Diagnosis and Non-Surgical Treatment of Sacroiliac Joint Pain - CAM 60123

Description
Sacroiliac joint (SIJ) arthrography using fluoroscopic guidance with an injection of an anesthetic has been explored as a diagnostic test for SIJ pain. Duplication of the patient’s pain pattern with the injection of contrast medium suggests a sacroiliac etiology, as does relief of chronic back pain with an injection of local anesthetic. Treatment of SIJ pain with corticosteroids, radiofrequency ablation (RFA), stabilization, or minimally invasive SIJ fusion has also been explored.

Objective
The objective of this evidence review is to evaluate the diagnostic and therapeutic use of corticosteroid injections and minimally invasive methods (radiofrequency ablation, sacroiliac joint fixation/fusion) for the diagnosis and treatment of sacroiliac joint pain.

Background   
SACROILIAC JOINT PAIN
Similar to other structures in the spine, it is assumed the sacroiliac joint (SIJ) may be a source of low back pain. In fact, before 1928, the SIJ was thought to be the most common cause of sciatica. In 1928, the role of the intervertebral disc was elucidated, and from that point forward, the SIJ received less research attention.

Diagnosis
Research into SIJ pain has been plagued by a lack of a criterion standard to measure its prevalence and against which various clinical examinations can be validated. For example, SIJ pain typically presents without any consistent, demonstrable radiographic or laboratory features and most commonly exists in the setting of morphologically normal joints. Clinical tests for SIJ pain may include various movement tests, palpation to detect tenderness, and pain descriptions by the patient. Further confounding the study of the SIJ is that multiple structures, (e.g., posterior facet joints, lumbar discs) may refer pain to the area surrounding the SIJ.

Because of inconsistent information obtained from history and physical examination, some have proposed the use of image-guided anesthetic injection into the SIJ for the diagnosis of SIJ pain. Treatments being investigated for SIJ pain include prolotherapy corticosteroid injection, radiofrequency ablation, stabilization, and arthrodesis. 

Regulatory Status
A number of radiofrequency generators and probes have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. In 2005, the SInergy® (Halyard; formerly Kimberly-Clark), a water-cooled single-use probe, was cleared by the FDA, listing the Baylis Pain Management Probe as a predicate device. The intended use is in conjunction with a radiofrequency generator to create radiofrequency lesions in nervous tissue.

FDA product codes: GXD, GXI.

Related Policies
20126 Prolotherapy
60125 Percutaneous Vertebroplasty and Sacroplasty
701116 Facet Joint Denervation
20194 Epidural Steroid Injections for Back Pain

Policy
Arthrography of the sacroiliac joint (SIJ) is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY.

Injection of anesthetic for diagnosing SIJ pain may be considered MEDICALLY NECESSARY when the following criteria have been met:

  • Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program.
  • Dual (controlled) diagnostic blocks with 2 anesthetic agents with differing duration of action are used.
  • The injections are performed under imaging guidance.

Injection of corticosteroid may be considered MEDICALLY NECESSARY for the treatment of SIJ pain when the following criteria have been met:

  • Pain has failed to respond to 3 months of conservative management, which may consist of therapies such as nonsteroidal anti-inflammatory medications, acetaminophen, manipulation, physical therapy, and a home exercise program.
  • The injection is performed under imaging guidance.
  • No more than 3 injections are given in 1 year.

Radiofrequency denervation of the SIJ is investigational/unproven therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines
This policy does not address the treatment of sacroiliac joint (SIJ) pain due to infection, trauma, or neoplasm.

Conservative nonsurgical therapy for the duration specified should include the following:

  • Use of prescription-strength analgesics for several weeks at a dose sufficient to induce a therapeutic response
    • Analgesics should include anti-inflammatory medications with or without adjunctive medications such as nerve membrane stabilizers or muscle relaxants.
  • Participation in at least 6 weeks of physical therapy (including active exercise) or documentation of why the individual could not tolerate physical therapy
  • Evaluation and appropriate management of associated cognitive, behavioral, or addiction issues
  • Documentation of individual compliance with the preceding criteria

A successful trial of controlled diagnostic lateral branch blocks consists of 2 separate positive blocks on different days with local anesthetic only (no steroids or other drugs), or a placebo-controlled series of blocks, under fluoroscopic guidance, that has resulted in a reduction in pain for the duration of the local anesthetic used (e.g., 3 hours longer with bupivacaine than lidocaine). There is no consensus on whether a minimum of 50% or 75% reduction in pain would be required to be considered a successful diagnostic block, although evidence supported a criterion standard of 75% to 100% reduction in pain with dual blocks. No therapeutic intra-articular injections (i.e., steroids, saline, other substances) should be administered for a period of at least 4 weeks before the diagnostic block. The diagnostic blocks should not be conducted under intravenous sedation unless specifically indicated (e.g., the individual is unable to cooperate with the procedure).

Coding
See the Codes table for details.

Benefit Application
BlueCard®/National Account Issues
State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Rationale
Diagnosis of Sacroiliac Joint Pain
Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

The use of diagnostic blocks to evaluate sacroiliac joint (SIJ) pain builds on the use of diagnostic blocks to evaluate pain in other joints. Blinded studies with placebo controls, although difficult to conduct when dealing with invasive procedures, are ideally required for scientific validation of SIJ blocks, particularly when dealing with pain relief well-known to respond to placebo controls. In the typical evaluation of a diagnostic test, the results of the sacroiliac diagnostic block would then be compared with a criterion standard. However, no current criterion standard for SIJ disease exists. In fact, some have positioned SIJ injection as the criterion standard against which other diagnostic tests and physical exam may be measured.2 Ultimately, the point of diagnosis is to select patients appropriately for treatment that improves outcomes. Diagnostic tests that differentiate patients who do or do not benefit from a particular treatment are clinically useful.

Clinical Context and Test Purpose
The purpose of diagnostic SIJ block in patients who have suspected SIJ pain is to inform a decision whether to proceed to appropriate treatment.

The question addressed in this evidence review is: Does the use of a diagnostic SIJ block improve the net health outcome in patients who have suspected SIJ pain?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with suspected SIJ pain.

Interventions
The test being considered is a diagnostic SIJ block. Sacroiliac blocks are administered under imaging guidance using a local anesthetic.

Comparators
The following practice is currently being used to diagnose SIJ pain: standard of care, which can include physical provocative tests to induce pain and diagnostic imaging. SIJ pain confirmed with at least 3 physical provocative tests and ≥ 50% acute decrease in pain upon SIJ diagnostic block following failed conservative management reflect typical criteria.

Outcomes
The general outcomes of interest are an accurate diagnosis, reductions in pain and medication usage, improvement in functional outcomes (e.g., activities of daily living), improvement in the quality of life (QOL), and adverse events (AEs). A diagnostic result should be available within 1 to 2 hours postinjection.

Study Selection Criteria
For the evaluation of the clinical validity of a diagnostic SIJ block, studies that meet the following eligibility criteria were considered:

  • Reported on the accuracy of the marketed version of the technology (including any algorithms used to calculate scores)
  • Included a suitable reference standard (including a description of the reference standard)
  • Patient/sample clinical characteristics were described
  • Patient/sample selection criteria were described

Clinically Valid
A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

Systematic Reviews
Simopoulous et al. (2015) conducted a systematic review evaluating 11 diagnostic accuracy studies.Studies were heterogeneous in patient selection, SIJ block procedure, assessment, and pain relief cutoff thresholds for diagnosis confirmation, which ranged from 50% to 90% reduction in pain. Four studies utilizing single blocks assessed at a cutoff threshold of at least a 75% decrease in pain score were found to have variable SIJ pain prevalence estimates of 10% to 64%. Eight studies utilizing dual blocks assessed at a cutoff threshold of at least a 70% decrease in pain score were found to have variable SIJ pain prevalence estimates of 10% to 40.4% with corresponding false-positive rates of 22% to 26%. The evidence for dual blocks was graded Level II.

Manchikanti et al. (2013) updated an evidence review with guidelines on the diagnosis of SIJ pain for the American Society of Interventional Pain Physicians.4 Various studies evaluating diagnostic blocks were reviewed in which the criteria for a positive test varied from 50% to 100% relief from either single or dual blocks. The most stringent criterion (75% to 100% relief with dual blocks) was evaluated in 7 studies. The prevalence of a positive test in the 7 studies ranged from 10% to 44.4% in patients with suspected sacroiliac disease. The evidence for diagnostic sacroiliac intra-articular injections was considered to be good using 75% to 100% pain relief with single or dual blocks as the criterion standard.

Manchikanti et al. (2010) published 2 systematic reviews for interventional techniques for treatment and diagnosis of low back pain.5,6 Evidence for diagnostic sacroiliac injections was considered to be fair to poor, and no additional literature was identified since a systematic review by Rupert et al. (2009).7

Chou et al. (2009) conducted 2 systematic reviews at the Oregon Evidence-based Practice Center that informed practice guidelines from the American Pain Society.8,9 The systematic reviews concluded that no reliable evidence existed to evaluate the validity or utility of diagnostic SIJ block as a diagnostic procedure for low back pain with or without radiculopathy, with a resulting guideline recommendation of insufficient evidence. Data on SIJ steroid injection were limited to a small controlled trial, resulting in a recommendation of insufficient evidence for therapeutic injection of this joint.

Clinically Useful
A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence
Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials (RCTs).

Direct evidence supporting the clinical utility of using diagnostic SIJ blocks in this population were not identified.

Chain of Evidence
Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Because the clinical validity of diagnostic SIJ blocks has not been established, a chain of evidence cannot be constructed.

Section Summary: Diagnosis of Sacroiliac Joint Pain
Findings from systematic reviews assessing the utility of diagnostic SIJ blocks are conflicting. In addition, there is no independent reference standard for the diagnosis of SIJ pain.

Treatment of Sacroiliac Joint Pain
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, QOL, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The RCT is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Treatment of Sacroiliac Joint Pain: Therapeutic Corticosteroid Injections
Clinical Context and Therapy Purpose

The purpose of therapeutic corticosteroid injections is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of therapeutic corticosteroid injections improve the net health outcome in individuals with SIJ pain?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with SIJ pain.

Interventions
The therapy being considered is a therapeutic corticosteroid injection.

Comparators
The following therapy is currently being used to treat SIJ: conservative management, including physical therapy.

Outcomes
The general outcomes of interest are symptoms (e.g., reductions in pain), functional outcomes, QOL, reductions in medication use, and treatment-related morbidity. Follow-up at 3 to 15 months is of interest to monitor outcomes.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and AEs, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews

Hansen et al. (2012) published a systematic review of SIJ interventions.10 The primary outcomes were short-term (≤ 6 months) or long-term (> 6 months) pain relief. Evidence quality was classified as good, fair, or limited/poor. Eleven studies (6 randomized, 5 nonrandomized trials) met the inclusion criteria. Reviewers found that evidence for intra-articular steroid injections was limited or poor, as was the evidence for periarticular injections (local anesthetic and steroid or botulinum toxin).

Randomized Controlled Trials
Tables 2 and 3 summarize the characteristics and results of select RCTs.

A trial by Visser et al. (2013) randomized 51 patients with SIJ and leg pain to physical therapy, manual therapy, or intra-articular injection of corticosteroid.11 Diagnosis of SIJ pain was based on provocation tests and not SIJ injections. In a blinded assessment, 25 (56%) patients were considered to be successfully treated at the 12-week follow-up visit based on complete relief of pain and improvement in the visual analog scale (VAS) score for pain.

Kim et al. (2010) reported a randomized, double-blind, controlled trial of intra-articular prolotherapy (see evidence review 2.01.26) compared with steroid injection for SIJ pain.12 The trial included 48 patients with SIJ pain. Intra-articular dextrose water prolotherapy or steroid injections were administered under fluoroscopic guidance on a biweekly schedule, with a maximum of 3 injections. Injections were stopped when pain relief was 90% or greater, which required a mean of 2.7 prolotherapy injections and 1.5 steroid injections. Pain (numeric rating scale) and disability (Oswestry Disability Index [ODI]) scores were assessed at baseline, 2 weeks, and then monthly upon completing treatment. At the 2-week follow-up, pain and disability scores were significantly improved in both groups, with no significant difference between groups. The numeric rating scale pain score improved from 6.3 to 1.4 in the prolotherapy group and from 6.7 to 1.9 in the steroid group. At 6 months after treatment, 63.6% of patients in the prolotherapy group remained improved from baseline (≥ 50%), compared with 27.2% in the steroid group. At the 15-month follow-up, the cumulative incidence of sustained pain relief was 58.7% in the prolotherapy group compared with 10.2% in the steroid group. The median duration of the recurrence of severe SIJ pain was 3 months for the steroid group.

Table 2. Characteristics of Key RCTs Assessing Therapeutic Corticosteroid Injection

Study Countries Sites Dates Participants Interventions
          Active Comparator
Visser et al. (2013)11 NL 1 NR Diagnosed with SIJ pain and/or leg pain between 4 wk and 1 y in duration 18 patients randomized to IA injection 15 patients randomized to PT and 18 to manual therapy
Kim et al. (2010)12 Korea 1 NR Diagnosed with SIJ paina who failed additional 1-mo treatment 26 patients randomized to steroid; 26 analyzed 24 patients randomized to IA prolotherapy; 23 analyzed

IA: intra-articular; NL: The Netherlands; NR: not reported; PT: physical therapy; RCT: randomized controlled trial; SIJ: sacroiliac joint.
a Confirmed by ≥ 50% improvement in response to a single local anesthetic block.

Table 3. Results of Key RCTs Assessing Therapeutic Corticosteroid Injection

Study Pain Outcomes Functional Outcomes
Visser et al. (2013)11 VAS (SD) RAND-36 Physical Functioning1
Baseline 3 Months Baseline 3 Months
IA Corticosteroid Injection 5.7 (1.7) 5.0 (1.9) 45.3 (16.8) 37.9 (15.4)
Physical therapy 4.3 (1.2) 3.9 (1.4) 27.5 (6.5) 51.25 (28.7)
Manual therapy 5.2 (1.4) 3.3 (2.3) 30.0 (18.6) 60.5 (24.3)
Kim et al. (2010)12 NRS (SD) ODI (SD)
Baseline 2 Weeks Baseline 2 Weeks
Steroid 6.7 (1.0) 1.4 (1.1) 35.7 (20.4) 15.5 (10.7)
Prolotherapy 6.3 (1.1) 1.4 (1.1) 33.9 (15.5) 11.1 (10)

IA: intra-articular; NRS: Numerical Rating Scale; ODI: Oswestry Disability Index; RCT: randomized controlled trial; SD: standard deviation; VAS: Visual Analog Scale
1 Survey measures of health-related quality of life scored on a scale from 0 to 100, with 100 representing the highest level of functioning in a given category.

The purpose of the study relevance, conduct, and design limitations tables (see Tables 4 and 5) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.

Table 4. Study Relevance Limitations

Study Populationa Interventionb Comparatorc Outcomesd Follow-Upe
Visser et al. (2013)11 4. Patients were recruited on the basis of SIJ-related leg pain with short duration of signs and symptoms. 2. Unclear which if any patients received a second injection.   4-5. Definition of successful treatment did not utilize standard pain relief threshold cutoff of at least 50%.  
Kim et al. (2010)12          

SIJ: sacroiliac joint.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 5. Study Design and Conduct Limitations

Study Allocationa Blindingb Selective Reportingc Data Completenessd Powere Statisticalf
Visser et al. (2013)11 3. Allocation not described. 1. Trial was single-blinded 1. Not registered.   2. Power not calculated for primary outcome. 3. Confidence intervals and/or p values not reported.
Kim et al. (2010)12 3. Allocation not described.   1. Not registered.    

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. No intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Case Series
Case series studies evaluating corticosteroid injections, described in systematic reviews, have shown variable findings at generally short-term follow-up.10,13

Section Summary: Therapeutic Corticosteroid Injections
Results from 2 small trials are insufficient to permit conclusions on the effect of this procedure on health outcomes. Steroid injections were not the most effective treatment in either trial and the degree of pain relief was limited. Larger trials with rigorous designs, preferably using sham injections, are needed to determine whether the treatment is effective.

Treatment of Sacroiliac Joint Pain: Radiofrequency Ablation
Clinical Context and Therapy Purpose

The purpose of radiofrequency ablation (RFA) is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with SIJ pain.

The question addressed in this evidence review is: Does the use of RFA improve the net health outcome in individuals with SIJ pain?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with SIJ pain.

Interventions
The therapy being considered is RFA, also known as radiofrequency neurotomy. RFA involves heating a portion of a pain-transmitting nerve to create a heat lesion. The goal of the heat lesion is to functionally denervate the SIJ and prevent the transmission of pain signals to the brain. Several variations of RFA are available, including water-cooled, pulsed, and conventional continuous RFA. Water-cooled RFA produces larger lesions than the other 2 modalities, however, lesion size is also dependent on temperature, needles size, and procedure duration. Lateral branch RFA targets the SIJ nerves.

Comparators
The following therapy is currently being used to treat SIJ pain: conservative therapy.

Outcomes
The general outcomes of interest are symptoms (e.g., reductions in pain), functional outcomes, QOL, reductions in medication use, and treatment-related morbidity. Follow-up at 3 and 15 months is of interest to monitor outcomes.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and AEs, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews

Tables 6 and 7 summarize the characteristics and results of select systematic reviews.

Chou et al. (2021) conducted a systematic review and meta-analysis on interventional treatments for acute and chronic pain for the Agency for Healthcare Research and Quality for use by the Centers for Medicare & Medicaid Services.14 The systematic review identified 2 trials (N = 79) on cooled RFA versus sham for SIJ pain with results at 3 months, and 1 trial (N = 28) on cooled RFA versus sham with results at 1 month. Meta-analysis indicated that cooled RFA is probably more effective for pain and function compared to sham at 1 and 3 months with moderate to large benefits. The strength of evidence was rated moderate for pain and function at 3 months and low for function at 1 month. When comparing cooled RFA to conventional RFA, 1 trial (N = 43) showed no differences at 1 or 3-month follow-up and a small, nonstatistically significant reduction in pain at 6 months. The strength of evidence was rated as low.

Chappel et al. (2020) performed a meta-analysis of RFA for chronic back pain.15 The review included 5 RCTs comparing RFA to sham or medical treatment in patients with chronic SIJ pain with follow-up from 1 to 3 months, and 1 study that had a follow-up to 12 months. This meta-analysis did not include pulsed RFA. Low-quality evidence indicated that RFA led to a modest reduction in pain at 1 to 3-month follow-up, but there was no significant reduction in pain in the single RCT (n = 228) that had 6- and 12-month follow-up.16 The RCT by Juch et al. (2017) with 12-month follow-up is described in greater detail below.

Chen et al. (2019) performed a meta-analysis of 5 RCTs comparing RFA to sham or medical treatment in patients with chronic SIJ pain.17 Various RFA procedures were represented, including percutaneous, cooled, and palisade SIJ radiofrequency neurotomy. Pain outcomes from all RCTs were pooled for the meta-analysis. Disability outcomes were only available for 2 studies utilizing cooled RFA. While studies showed no significant heterogeneity for disability outcomes, heterogeneity was high for pain outcomes.

Table 6. Characteristics of Systematic Reviews

Study Dates Trials Participants N (Range) Design Duration, mo
Chou et al. (2021)14 2007 – 2021 3 Patients with chronic SIJ pain treated by various RFA procedures compared to sham. 122 (28 to 51) RCTs 1 to 3
Chappel et al. (2020)15 2008 – 2019 5 Patients with chronic SIJ pain treated by various RFA procedures compared to sham or medical treatment. One trial with 12 mo follow-up had 228 participants. 384 RCTs 3 to 12
Chen et al. (2019)17 2012 – 2018 5 Patients with chronic SIJ pain treated by various RFA procedures compared to sham or medical treatment 311 (28 to 155) RCTs 3 to 6

SIJ: sacroiliac joint; RCT: randomized controlled trial; RFA: radiofrequency ablation.

Table 7. Results of Systematic Reviews

Study Pain Score Pain Score ODI Score GPE Score
Chou et al. (2021)14 3 mo vs sham RFA 6 mo vs conventional RFA    
Total N 79      
Cooled RFA -2.4 -3.8    
Sham or coventional RFA -0.8 -3.0    
p .04 .041    
Chappel et al. (2020)15 1 to 3 mo 6 mo    
Total N 5 studies1; n = 384 1 study1; n = 228    
MD (95% CI) -1.53 (-2.62 to 0.45) -0.28 (-1.00 to 0.44)    
p .02      
I2 (p) 83% NA    
Chen et al. (2019)17 Various RFA        
Total N 5 studies1; n = 311 See NRS Score1 2 studies; n = 79 1 study; n = 60
MD (95% CI) -2.13 (-3.4 to -0.87)   -8.91 (-16.44 to -1.38) 0.60 (-0.09 to 1.29)
p .001   .020 .090
I2 (p) 82.3% (NR)   44.8% (NR) NR

CI: confidence interval; GPE: Global Perceived Effect; MD: mean difference; NA: not applicable; NR: not reported; NRS: numerical rating scale; ODI: Oswestry Disability Index; RFA: radiofrequency ablation; VAS: visual analog score.
1 All pain scores (NRS, VAS) utilizing an 11-point scoring system were pooled together for the meta-analysis. 

Randomized Controlled Trials
Tables 8 and 9 summarize the characteristics and results of select RCTs.

Table 8. Characteristics of Key RCTs Assessing Radiofrequency Ablation

Study Countries Sites Dates Participants Interventions
          Active Comparator
Mehta et al. (2018)18 UK 1 2012 – 2015 Patients with SIJ pain confirmed by diagnostic intra-articular injection; only 17 of 30 enrolled patients were randomized due to results of interim analysis Multi-probe strip lesion RFA (n = 11) Sham (n = 6)
4 patients crossed over to active group after 3-month endpoint
Juch et al. (2017)16 Netherlands 16 2013 – 2014 Patients with chronic low back pain related to the SIJ RFA + exercise program (n = 116)
110 received RFA
81 received Palisade radiofrequency treatment
23 received cooled RFA
6 received multi-probe strip lesion RFA
Exercise program (n = 112)
69 completed program
18 did not complete program
25 with unknown completion
Van Tilburg et al. (2016)19 Netherlands NR 2012 – 2014 Patients with SIJ pain Percutaneous RFA to lateral branch and dorsal root primary ramus (n = 30) Sham (n = 30)
Zheng et al. (2014)20 China 1 2010 – 2012 Patients with ankylosing spondylitis and SIJ pain PSRN with computed tomography guidance (n = 82) Celecoxib treatment (n = 73)
Patel et al. (2012; 2016)21,22 U.S. NR 2008 – 2010 Patients with SIJ pain Lateral branch cooled RFA (n = 34) Sham (n = 17)

NR: not reported; PSRN: palisade sacroiliac joint radiofrequency neurotomy; RFA: radiofrequency ablation; RCT: randomized controlled trial: SIJ: sacroiliac joint.

Table 9. Results of Key RCTs Assessing Radiofrequency Ablation

Study Pain Outcomes Functional Outcomes Treatment Success
Mehta et al. (2018)18 NRS at Baseline (SD) NRS at Month 3 (SD) PCS1 at Baseline (SD) PCS at Month 3 (SD) Treatment Success
Strip lesion RFA 8.1 (0.8) 3.4 (2.0) 28.4 (7.1) 34.7 (10.8) NR
Sham 6.5 (2.0) 7.3 (0.8) 28.6 (5.0) 29.6 (5.6) NR
p Value NR < .001 NR 0.0645 NR
Juch et al. (2017)16 NRS at Month 3 (95% CI) NRS at Month 12 (95% CI) ODI at Month 3 (95% CI) ODI at Month 12 (95% CI) At Month 3, n/N (%) At Month 12, n/N (%)
RFA + exercise program 4.77 (4.31 to 5.24) 4.65 (4.16 to 5.13) 27.72 (24.50 to 30.95) 27.29 (23.89 to 30.69) 43/110 (39.10) 49/102 (48.03)
Exercise program 5.45 (4.94 to 5.95) 4.84 (4.30 to 5.38) 29.09 (25.47 to 2.71) 24.49 (20.74 to 28.23) 19/88 (21.59) 24/76 (31.78)
MD/RR (95% CI) -0.71 (-1.35 to -0.06) -0.07 (-0.74 to 0.60) -4.20 (-8.39 to -0.00) 2.11 (-2.25 to 6.47) 1.87 (1.13 to 2.71) 1.46 (0.92 to 2.02)
p Value .03 .83 .05 .34 .02 .10
Van Tilburg et al. (2016)19 Mean NRS at Baseline (SD) Mean NRS at Month 1 (SD) Mean GPE at Month 1 (SD) Mean GPE at Month 3 (SD) Treatment Success
Percutaneous RFA 7.2 (1.4) 5.4 (1.7) 3.2 (1.1) 3.4 (1.6) NR
Sham 7.5 (1.2) 5.4 (1.9) 3.3 (1.0) 3.4 (1.5) NR
P Value NR NR NR NR NR
Zheng et al. (2014)20 VAS at Week 12 (95% CI) VAS at Week 24 (95% CI) Mean BASFI2 at Baseline (95% CI) BASFI at Week 24 (95% CI) Treatment Success
PSRN 2.5 (2.2 to 3.0) 2.8 (2.5 to 3.2) 5.4 (5.0 to 5.8) 3.1 (2.7 to 3.6) NR
Celecoxib 4.4 (4.0 to 4.9) 5.0 (4.6 to 5.3) 5.3 (4.8 to 5.8) 5.0 (4.5 to 5.5) NR
MD (95% CI) -1.9 (-2.4 to -1.4) -2.2 (-2.6 to -1.6) NR -1.9 (-2.5 to -1.2) NR
p Value < .0001 < .0001 NR < .0001 NR
Patel et al. (2012; 2016)21,22 NRS at Baseline (SD) NRS at Month 3 (SD) ODI at Baseline (SD) ODI at Month 9 (SD) At Month 3, n/N (%) At Month 6, n/N (%)
Cooled RFA 6.1 (1.3) -2.4 (2.7) 37 (14) -11 (17) 16/34 (47) 13/34 (38)
Sham 5.8 (1.3) -0.8 (2.4) 35 (10) 2 (6) 2/17 (12) 7/16 (44)3
p Value .370 .035 .639 .011 .015 NR

BASFI: Bath Ankylosing Spondylitis Functional Index; CI; confidence interval; GPE: Global Perceived Effect; MD: mean difference; NR: not reported; NRS; Numeric Rating Scale; ODI: Oswestry Disability Index; PCS: Physical Component Score; RCT: randomized control trial; RFA: radiofrequency ablation; RR: relative risk; SD: standard deviation; VAS; Visual Analog Scale.
1 Higher scores on the SF-12 Physical Component Score (PCS) indicate improved outcomes.
2 The Bath Ankylosing Spondylitis Functional Index (BASFI) measures overall functional outcomes on a scale from 0 to 10 with 0 indicating best possible functioning.
3 Patients assigned to the sham group were allowed to crossover to active treatment after the 3-month study endpoint.

Mehta et al. (2018) published results from a double-blind, randomized, sham-controlled trial assessing the efficacy of radiofrequency neurotomy with a strip-lesioning device in patients with chronic SIJ pain.18 Seventeen of 30 enrolled patients were randomized to active (n = 11) or sham (n = 6) treatment. Recruitment was terminated after an interim analysis indicated a statistically significant difference in the pain outcome between groups. After the 3-month study endpoint, patients receiving sham treatment were allowed to crossover. While a statistically significant reduction in pain scores was reported at 3 months, there was no significant difference in functional outcome as measured by the Physical Component Score at 3 months. Due to the crossover design, it is difficult to gauge long-term outcomes and durability of the treatment.

Juch et al. (2017) reported a nonblinded multicenter RCT of radiofrequency denervation in 228 of 2498 patients with suspected sacroiliac pain who were asked to participate in the trial.16 Patient selection criteria included body mass index (< 35 kg/m2), age (< 70 years old), and pain reduction of at least 50% within 30 to 90 minutes of receiving a diagnostic sacroiliac block (n = 228). An additional 202 patients had a negative diagnostic sacroiliac block; 1666 patients declined to participate in the trial. Patients meeting criteria were randomized to exercise plus radiofrequency denervation (n = 116) or an exercise program alone (n = 112) and were followed for a year. The RFA group had a modest improvement for the primary outcome at 3 months (-0.71; 95% confidence interval [CI]: -1.35 to -0.06), but the control group improved over time and there were no statistically significant differences between the groups for pain intensity score (p = .09) or in the number of patients who had more than a 30% reduction in pain intensity (p = .48) at 12 months. Limitations included the use of several techniques to achieve radiofrequency denervation, self-selection, lack of blinding, and a high dropout rate (31%) in the control group.

Van Tilburg et al. (2016) reported a sham-controlled randomized trial of percutaneous RFA in 60 patients with SIJ pain.19 Patients selected had clinically suspected SIJ pain and a decrease of 2 or more points on a 10-point pain scale with a diagnostic sacroiliac block. At 3-month follow-up, there was no statistically significant difference in pain level over time between groups (group by period interaction, p = .56). Both groups improved over time (≥ 2 points out of 10; p-value for time, p < .001). In their discussion, trialists mentioned the criteria and method used for diagnosing SIJ pain might have resulted in the selection of some patients without SIJ pain.

Zheng et al. (2014) reported on an RCT of palisade sacroiliac RFA in 155 patients with ankylosing spondylitis.20 Palisade RFA uses a row of radiofrequency cannulae perpendicular to the dorsal sacrum. Inclusion criteria were ages 18 to 75 years; diagnosis of ankylosing spondylitis; chronic low back pain for at least 3 months; axial pain below L5; no peripheral involvement; pain aggravation on manual pressing of the SIJ area; and at least 50% pain relief following fluoroscopically guided anesthetic injection into the joint. Patients who met the inclusion criteria were randomized to palisade RFA or celecoxib. Blinded evaluation to 24 weeks found that RFA (2.8) resulted in lower global VAS scores than celecoxib (5.0; p < .001) as well as improved scores for secondary outcome measures. This study lacked a sham control.

Patel et al. (2012) reported a randomized, double-blind, placebo-controlled trial of lateral branch neurotomy with a cooled radiofrequency probe.21 Twelve-month follow-up was reported in 2016.22 Fifty-one patients who had a positive response to 2 lateral branch blocks were randomized 2:1 to lateral branch radiofrequency or to sham. At a 3-month follow-up, significant improvements were observed in pain levels (-2.4 vs -0.8), physical function (14 vs 3), disability (-11 vs 2), and QOL (0.09 vs 0.02) for radiofrequency treatment compared with controls (all respectively). With treatment success defined as a 50% or greater reduction in numeric rating scale score, 47% of radiofrequency-treated patients and 12% of sham-treated patients achieved treatment success. The treatment response was durable to 12 months in the 25 of 34 patients who completed all follow-up visits.22 Of the 9 patients who terminated study participation, 4 (12%) of 34 were considered treatment failures.

Tables 10 and 11 display notable relevance, design, and conduct limitations identified in each study.

Table 10. Study Relevance Limitations

Study Populationa Interventionb Comparatorc Outcomesd Follow-Upe
Mehta et al. (2019)18       1. Disability outcomes were not reported.  
Juch et al. (2017)16 4. Patients older than 70 years were excluded.   2. Not a sham control.    
Van Tilburg et al. (2016)19          
Zheng et al. (2014)20 1. Patients were required to have a diagnosis of ankylosing spondylitis in addition to chronic low back pain related to the SIJ.   2. Not a sham control.    
Patel et al. (2012)21,22        

SIJ: sacroiliac joint.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not established and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 11. Study Design and Conduct Limitations

Study Allocationa Blindingb Selective Reportingc Data Completenessd Powere Statisticalf
Mehta et al. (2019)18       3. 66.6% of sham group patients crossed over to treatment group at 3 mo Other: Small study size due to interim analysis  
Juch et al. (2017)16   1-2. Study was not blinded.        
Van Tilburg et al. (2016)19       3. 63.3% of sham group patients crossed over to the treatment group    
Zheng et al. (2014)20            
Patel et al. (2012)21,22       3. Patients in the sham group could cross over at 3 mo  

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.

Section Summary: Radiofrequency Ablation
Meta-analysis of available sham-controlled RCTs suggests that there may be a small effect of RFA on SIJ pain at short-term (1 to 3 months) follow-up. However, the randomized trials of RFA have methodologic limitations, and there is limited data on the duration of the treatment effect. The single RCT with 6 and 12-month follow-up showed no significant benefit of RFA compared to an exercise control group at these time points. In addition, heterogeneity of RFA treatment techniques precludes generalizing results across different studies.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2017 Input
Clinical input was sought to help determine whether the use of sacroiliac joint (SIJ) fusion for individuals with SIJ pain would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 10 respondents, including 5 specialty society-level responses from 7 specialty societies (2 were joint society responses) and 5 physician-level responses from 4 academic centers while this policy was under review in 2017.

For carefully selected patients as outlined in statements from the North American Spine Society who have SIJ pain who receive percutaneous and minimally invasive techniques of SIJ fusion, the clinical input supports this use provides a clinically meaningful improvement in the net health outcome and is consistent with generally accepted medical practice.

Further details from clinical input are included in the Appendix.

2014 Input
In response to requests, input was received from 4 physician specialty societies and 4 academic medical centers (5 responses) while this policy was under review in 2014. Input was mixed on the use of arthrography, radiofrequency ablation, and fusion of the SIJ. Most reviewers considered injection for diagnostic purposes to be medically necessary when using controlled blocks with at least 75% pain relief, and for injection of corticosteroids for treatment purposes. Treatment with prolotherapy, periarticular corticosteroid, and periarticular botulinum toxin were considered investigational by most reviewers.

2010 Input
In response to requests, input was received from 4 physician specialty societies (6 responses) and 3 academic medical centers (5 responses) while this policy was under review in 2010. Input was mixed. There was general agreement that the evidence for SIJ injections is limited, although most reviewers considered sacroiliac injections to be the best available approach for diagnosis and treatment in defined situations.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

North American Spine Society
The North American Spine Society (NASS) has developed appropriate use criteria for percutaneous SIJ fusion, SIJ injection, and radiofrequency ablation. These criteria can be accessed by payers through a registration process. For further information, see https://www.spine.org/Research-Clinical-Care/Quality-Improvement/Clinical-Guidelines.

American Society of Interventional Pain Physicians
In 2013, the American Society of Interventional Pain Physicians guideline recommended the use of controlled SIJ blocks with placebo or controlled comparative local anesthetic block when indications are satisfied with suspicion of SIJ pain.4 A positive response to a joint block is considered to be at least a 75% improvement in pain or in the ability to perform previously painful movements. For therapeutic interventions, the only effective modality with fair evidence was cooled radiofrequency neurotomy, when used after the appropriate diagnosis was confirmed by diagnostic SIJ injections.

American Society of Anesthesiologists & American Society of Regional Anesthesia and Pain Medicine
The American Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine have a 2010 guideline for chronic pain management.44 The guideline recommends that “Diagnostic sacroiliac joint injections or lateral branch blocks may be considered for the evaluation of patients with suspected sacroiliac joint pain.” Based on the opinions of consultants and society members, the guideline recommends that “Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain.”

International Society for the Advancement of Spine Surgery
In 2020, the International Society for the Advancement of Spine Surgery provided guidance on indications for minimally invasive SIJ fusion with placement of lateral transfixing devices.39

The Society recommended that "patients who have all of the following criteria may be eligible for lateral MIS [minimally invasive surgical] SIJF with placement of lateral transfixing devices:

  • Chronic SIJ pain (pain lasting at least 6 months)
  • Significant SIJ pain that impacts QOL [quality of life] or significantly limits activities of daily living
  • SIJ pain confirmed with at least 3 physical examination maneuvers that stress the SIJ [list provided above] and reproduce the patient’s typical pain
  • Confirmation of the SIJ as a pain generator with > 50% acute decrease in pain upon fluoroscopically guided diagnostic intra-articular SIJ block using a small volume (< 2.5 mL) of local anesthetic
  • Failure to respond to nonsurgical treatment consisting of NSAIDs [nonsteroidal anti-inflammatory drugs] and a reasonable course (4 to 6 weeks) of PT [physical therapy]. Failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability."

It was recommended that intra-articular SIJ steroid injection and radiofrequency ablation (RFA) of the SIJ lateral branch nerves may be considered but are not required.

Specifically not recommended were:

  • Minimally invasive posterior (dorsal) SIJ fusion.
  • Repeat intra-articular steroid injection.
  • Repeat SIJ radiofrequency ablation.

American Society of Pain and Neuroscience
In 2021, the American Society of Pain and Neuroscience published practice a guideline on radiofrequency neurotomy.45 All of the workgroup members utilized radiofrequency neurotomy in clinical practice. A consensus statement, based on Grade II-1 evidence (well-designed, controlled, nonrandomized clinical trial), was that "lateral branch radiofrequency neurotomy may be used for the treatment of posterior sacral ligament and joint pain following positive response to appropriately placed diagnostic blocks."

National Institute for Health and Care Excellence
In 2017, the National Institute for Health and Care Excellence guidance on minimally invasive SIJ fusion surgery for chronic sacroiliac pain included the following recommendations:

1.1 "Current evidence on the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery for chronic SI pain is adequate to support the use of this procedure.
1.2 Patients having this procedure should have a confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.
1.3 This technically challenging procedure should only be done by surgeons who regularly use image-guided surgery for implant placement. The surgeons should also have had specific training and expertise in minimally invasive SI joint fusion surgery for chronic SI pain.”46

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this policy are listed in Table 19.

Table 19. Summary of Key Trials

NCT No. Trial Name Planned Enrollment Completion Date
Ongoing      
NCT03601949a A Prospective, Multi-Center, Randomized, Assessor Blind, Controlled Study Comparing Lateral Branch Cooled Radiofrequency Denervation to Conservative Therapy as Treatment for Sacroiliac Joint Pain in a Military and Civilian Population 210 Jul 2022

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.

References

  1. Himstead AS, Brown NJ, Shahrestani S, et al. Trends in Diagnosis and Treatment of Sacroiliac Joint Pathology Over the Past 10 Years: Review of Scientific Evidence for New Devices for Sacroiliac Joint Fusion. Cureus. Jun 2021; 13(6): e15415. PMID 34249562
  2. Dreyfuss P, Michaelsen M, Pauza K, et al. The value of medical history and physical examination in diagnosing sacroiliac joint pain. Spine (Phila Pa 1976). Nov 15 1996; 21(22): 2594-602. PMID 8961447
  3. Simopoulos TT, Manchikanti L, Gupta S, et al. Systematic Review of the Diagnostic Accuracy and Therapeutic Effectiveness of Sacroiliac Joint Interventions. Pain Physician. Sep-Oct 2015; 18(5): E713-56. PMID 26431129
  4. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. Apr 2013; 16(2 Suppl): S49-283. PMID 23615883
  5. Manchikanti L, Datta S, Derby R, et al. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 1. Diagnostic interventions. Pain Physician. May-Jun 2010; 13(3): E141-74. PMID 20495596
  6. Manchikanti L, Datta S, Gupta S, et al. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. Jul-Aug 2010; 13(4): E215-64. PMID 20648212
  7. Rupert MP, Lee M, Manchikanti L, et al. Evaluation of sacroiliac joint interventions: a systematic appraisal of the literature. Pain Physician. Mar-Apr 2009; 12(2): 399-418. PMID 19305487
  8. Chou R, Atlas SJ, Stanos SP, et al. Nonsurgical interventional therapies for low back pain: a review of the evidence for an American Pain Society clinical practice guideline. Spine (Phila Pa 1976). May 01 2009; 34(10): 1078-93. PMID 19363456
  9. Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). May 01 2009; 34(10): 1066-77. PMID 19363457
  10. Hansen H, Manchikanti L, Simopoulos TT, et al. A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions. Pain Physician. May-Jun 2012; 15(3): E247-78. PMID 22622913
  11. Visser LH, Woudenberg NP, de Bont J, et al. Treatment of the sacroiliac joint in patients with leg pain: a randomized-controlled trial. Eur Spine J. Oct 2013; 22(10): 2310-7. PMID 23720124
  12. Kim WM, Lee HG, Jeong CW, et al. A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. J Altern Complement Med. Dec 2010; 16(12): 1285-90. PMID 21138388
  13. Kennedy DJ, Engel A, Kreiner DS, et al. Fluoroscopically Guided Diagnostic and Therapeutic Intra-Articular Sacroiliac Joint Injections: A Systematic Review. Pain Med. Aug 2015; 16(8): 1500-18. PMID 26178855
  14. Chou R, Fu R, Dana T, Pappas M, Hart E, Mauer KM. Interventional Treatments for Acute and Chronic Pain: Systematic Review. Comparative Effectiveness Review No. 247. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 75Q80120D00006.) AHRQ Publication No. 21-EHC030. Rockville, MD: Agency for Healthcare Research and Quality; September 2021. PMID: 34524764
  15. Chappell ME, Lakshman R, Trotter P, et al. Radiofrequency denervation for chronic back pain: a systematic review and meta-analysis. BMJ Open. Jul 21 2020; 10(7): e035540. PMID 32699129
  16. Juch JNS, Maas ET, Ostelo RWJG, et al. Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials. JAMA. Jul 04 2017; 318(1): 68-81. PMID 28672319
  17. Chen CH, Weng PW, Wu LC, et al. Radiofrequency neurotomy in chronic lumbar and sacroiliac joint pain: A meta-analysis. Medicine (Baltimore). Jun 2019; 98(26): e16230. PMID 31261580
  18. Mehta V, Poply K, Husband M, et al. The Effects of Radiofrequency Neurotomy Using a Strip-Lesioning Device on Patients with Sacroiliac Joint Pain: Results from a Single-Center, Randomized, Sham-Controlled Trial. Pain Physician. Nov 2018; 21(6): 607-618. PMID 30508988
  19. van Tilburg CW, Schuurmans FA, Stronks DL, et al. Randomized Sham-controlled Double-Blind Multicenter Clinical Trial to Ascertain the Effect of Percutaneous Radiofrequency Treatment for Sacroiliac Joint Pain: Three-month Results. Clin J Pain. Nov 2016; 32(11): 921-926. PMID 26889616
  20. Zheng Y, Gu M, Shi D, et al. Tomography-guided palisade sacroiliac joint radiofrequency neurotomy versus celecoxib for ankylosing spondylitis: a open-label, randomized, and controlled trial. Rheumatol Int. Sep 2014; 34(9): 1195-202. PMID 24518967
  21. Patel N, Gross A, Brown L, et al. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. Mar 2012; 13(3): 383-98. PMID 22299761
  22. Patel N. Twelve-Month Follow-Up of a Randomized Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Region Pain. Pain Pract. Feb 2016; 16(2): 154-67. PMID 25565322
  23. Whang P, Cher D, Polly D, et al. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 2015; 9: 6. PMID 25785242
  24. Polly DW, Cher DJ, Wine KD, et al. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. Nov 2015; 77(5): 674-90; discussion 690-1. PMID 26291338
  25. Polly DW, Swofford J, Whang PG, et al. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016; 10: 28. PMID 27652199
  26. Darr E, Meyer SC, Whang PG, et al. Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants. Med Devices (Auckl). 2018; 11: 113-121. PMID 29674852
  27. Sturesson B, Kools D, Pflugmacher R, et al. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. Mar 2017; 26(3): 708-719. PMID 27179664
  28. Dengler J, Sturesson B, Kools D, et al. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial. Acta Neurochir (Wien). Nov 2016; 158(11): 2219-2224. PMID 27629371
  29. Dengler JD, Kools D, Pflugmacher R, et al. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. Sep 2017; 20(6): 537-550. PMID 28934785
  30. Dengler J, Kools D, Pflugmacher R, et al. Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint. J Bone Joint Surg Am. Mar 06 2019; 101(5): 400-411. PMID 30845034
  31. Duhon BS, Cher DJ, Wine KD, et al. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Global Spine J. May 2016; 6(3): 257-69. PMID 27099817
  32. Duhon BS, Bitan F, Lockstadt H, et al. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016; 10: 13. PMID 27162715
  33. Whang PG, Darr E, Meyer SC, et al. Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants. Med Devices (Auckl). 2019; 12: 411-422. PMID 31576181
  34. Patel V, Kovalsky D, Meyer SC, et al. Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants. Med Devices (Auckl). 2020; 13: 173-182. PMID 32607011
  35. Vanaclocha V, Herrera JM, Saiz-Sapena N, et al. Minimally Invasive Sacroiliac Joint Fusion, Radiofrequency Denervation, and Conservative Management for Sacroiliac Joint Pain: 6-Year Comparative Case Series. Neurosurgery. Jan 01 2018; 82(1): 48-55. PMID 28431026
  36. Spain K, Holt T. Surgical Revision after Sacroiliac Joint Fixation or Fusion. Int J Spine Surg. 2017; 11: 5. PMID 28377863
  37. Schoell K, Buser Z, Jakoi A, et al. Postoperative complications in patients undergoing minimally invasive sacroiliac fusion. Spine J. Nov 2016; 16(11): 1324-1332. PMID 27349627
  38. Tran ZV, Ivashchenko A, Brooks L. Sacroiliac Joint Fusion Methodology - Minimally Invasive Compared to Screw-Type Surgeries: A Systematic Review and Meta-Analysis. Pain Physician. Jan 2019; 22(1): 29-40. PMID 30700066
  39. Lorio M, Kube R, Araghi A. International Society for the Advancement of Spine Surgery Policy 2020 Update-Minimally Invasive Surgical Sacroiliac Joint Fusion (for Chronic Sacroiliac Joint Pain): Coverage Indications, Limitations, and Medical Necessity. Int J Spine Surg. Dec 2020; 14(6): 860-895. PMID 33560247
  40. Rappoport LH, Luna IY, Joshua G. Minimally Invasive Sacroiliac Joint Fusion Using a Novel Hydroxyapatite-Coated Screw: Preliminary 1-Year Clinical and Radiographic Results of a 2-Year Prospective Study. World Neurosurg. May 2017; 101: 493-497. PMID 28216399
  41. Rappoport LH, Helsper K, Shirk T. Minimally invasive sacroiliac joint fusion using a novel hydroxyapatite-coated screw: final 2-year clinical and radiographic results. J Spine Surg. Jun 2021; 7(2): 155-161. PMID 34296027
  42. Araghi A, Woodruff R, Colle K, et al. Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Open Orthop J. 2017; 11: 1440-1448. PMID 29387289
  43. Fuchs V, Ruhl B. Distraction arthrodesis of the sacroiliac joint: 2-year results of a descriptive prospective multi-center cohort study in 171 patients. Eur Spine J. Jan 2018; 27(1): 194-204. PMID 29058134
  44. Benzon HT, Connis RT, De Leon-Casasola OA, et al. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. Apr 2010; 112(4): 810-33. PMID 20124882
  45. Lee DW, Pritzlaff S, Jung MJ, et al. Latest Evidence-Based Application for Radiofrequency Neurotomy (LEARN): Best Practice Guidelines from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2021; 14: 2807-2831. PMID 34526815
  46. National Institute for Health and Care Excellence. Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain [IPG578]. 2017; https://www.nice.org.uk/guidance/ipg578. Accessed October 4, 2022.

Coding Section

Codes

Number

Description

CPT

   
 

20610

Arthrocentesis, aspiration and/or injection, major joint or bursa (e.g., shoulder, hip, knee, subacromial bursa); without ultrasound guidance

 

27096

Injection procedure for sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy or CT) including arthrography when performed

 

64451

Injection anesthetic agent, nerves innervating the sacroiliac joint with image guidance

 

64625

Radiofrequency ablation, nerves innervating the sacroiliac joint, with image guidance (ie, fluoroscopy or computed tomography)

 

0775T (deletion 01/01/2024)

Arthrodesis, sacroiliac joint, percutaneous, with image guidance, includes placement of intra-articular implant(s) (e.g., bone allograft[s], synthetic device[s]) (eff 01/01/2023)

 

0809T (deletion 01/01/2024)

Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, placement of transfixing device(s) and intraarticular implant(s), including allograft or synthetic device(s) (eff 07/01/2023)

HCPCS

G0259

Injection procedure for sacroiliac joint; arthrography

 

G0260

Injection procedure for sacroiliac joint; provision of anesthetic, steroid and/or other therapeutic agent, with or without arthrography

ICD-10-CM

M46.1

Sacroiliitis, not elsewhere classified

 

M47.898

Other spondylosis, sacral and sacrococcygeal region

 

M47.899

Other spondylosis, site unspecified

 

M48.08

Spinal stenosis, sacral and sacrococcygeal region

 

M53.2X8

Spinal instabilities, sacral and sacrococcygeal region

 

M54.18

Radiculopathy, sacral and sacrococcygeal region

 

M54.30-M54.32

Sciatica; code range

 

M54.40-M54.42

Lumbago with sciatica; code range

 

M54.50-M54.59

Lower back pain; code range

 

M54.6

Pain in thoracic spine

 

S33.2

Dislocation of sacroiliac and sacrococcygeal joint

 

S33.6

Sprain of sacroiliac joint

ICD-10-PCS

 

ICD-10-PCS codes are only used for inpatient services

 

3E0U33Z, 3E0U3BZ, 3E0U3JZ, 3E0U3NZ

Administration, physiological systems and anatomical regions, introduction, joints, percutaneous, code by substance introduced (anti-inflammatory, anesthetic, contrast agent, analgesic)

 

BR0D0ZZ

Imaging, plain radiography of sacroiliac joints using high osmolar contrast

 

BR0D1ZZ

Imaging, plain radiography of sacroiliac joints using low osmolar contrast

 

BR0DYZZ

Imaging, plain radiography of sacroiliac joints using other contrast

 

0S573ZZ, 0S583ZZ

Surgical, lower joints, destruction, sacroiliac joints (right and left codes), no device

 

0SG704Z, 0SG804Z, 0SG707Z, 0SG807Z, 0SG70JZ, 0SG80JZ, 0SG70KZ, 0SG80KZ, 0SG70ZZ, 0SG80ZZ

Surgical, lower joints, fusion, open, sacroiliac joints (right and left codes) and various devices

 

0SG734Z, 0SG834Z, 0SG737Z, 0SG837Z, 0SG73JZ, 0SG83JZ, 0SG73KZ, 0SG83KZ, 0SG73ZZ, 0SG83ZZ

Surgical, lower joints, fusion, percutaneous, sacroiliac joints (right and left codes) and various devices

 

0SG744Z, 0SG844Z, 0SG747Z, 0SG847Z, 0SG74JZ, 0SG84JZ, 0SG74KZ, 0SG84KZ, 0SG74ZZ, 0SG84ZZ

Surgical, lower joints, fusion, percutaneous endoscopic, sacroiliac joints (right and left codes) and various devices

Type of Service

Medicine

 

Place of Service

Outpatient

 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward     

02/07/2024 Annual review, no change to policy intent. Updating description and background. Removing CPT code 27278 as that procedure is not addressed in this policy.
12/15/2023 Added CPT code 20278 eff 01/01/2024 and note for code deletion of 0775T and 809T
10/25/2023 Interim review removing SI joint infusion from policy as a new policy specific to SI joint infusion is being published.
03/13/2023 Adding CPT 0809T effective 04012023
02/02/2023 Annual review, no change to policy intent. Updating guidelines, rationale and references.

02/03/2022 

Annual review, adding policy verbiage related to transiliac placement of a titanium triangular implant. Also updating coding, description, background, rationale and references. Also updating regulatory status 

12/7/2021 

Updating policy with 2022 coding. Adding code 64628 and 64629. No other change made. 

06/01/2021

Adding archival date to related policy number 

02/10/2021 

Annual review, no change to policy intent. Updating description, rationale and references. 

02/03/2020 

Annual review, no change to policy intent. Updating rationale and references. 

02/13/2019 

Annual review, no change to policy intent. Updating description, rationale and references. 

03/13/2018 

Annual review, updating related policies, background, description, rationale and references. 

01/31/2018 

Interim review, updating title to indicate this policy relates to non surgical treatment of SI joint pain as a new policy title Sarcriliac Joint Fusion of Stabilization is being published. Removing surgical treatment from multiple areas of the policy. No change to the intent of diagnosis and non surgical treatment of SI joint pain. 

02/01/2017 

Annual review, no change to policy intent. Updating background, description, guidelines, rationale and references. 

02/15/2016 

Annual review, no change to policy intent. 

02/16/2015 

Added verbiage related to cooled RFA to guidelines. 

12/16/2014 

Updated to add: Injection of corticosteroid may be considered medically necessary for the treatment of sacroiliac joint.

02/24/2014

Annual review. Added regulatory status & related policies. Updated rationale, references and policy verbiage related to S/I fusion & stabilization. Intent unchanged.

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