Description
Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Electromyography biofeedback has been evaluated as a method to reduce chronic or recurrent pain of musculoskeletal or psychosomatic origin.

For individuals who have chronic pain (including low back, knee, neck and shoulder, orofacial, and abdominal pain as well as fibromyalgia, osteoarthritis, systemic lupus erythematosus, and vulvar vestibulitis) who receive biofeedback, the evidence includes multiple randomized controlled trials (RCTs) for different pain syndromes. The relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The results of these RCTs, some of which were sham-controlled, did not consistently report a benefit for biofeedback. Some RCTs reported improved outcomes with biofeedback, but these improvements were often of uncertain clinical significance or were not durable. Many other RCTs have found that biofeedback did not provide a significantly greater benefit in outcomes when it was used instead of or in addition to other conservative interventions such as exercise. Overall, the available RCTs were limited by small sample sizes and high dropout rates. This evidence base does not permit conclusions about the specific effects of biofeedback beyond the nonspecific effects of sham interventions, nor does it permit conclusions about the contribution of biofeedback beyond that of other conservative treatments for pain. The evidence is insufficient to determine the effects of the technology on health outcomes.   

Background
Biofeedback is a technique intended to teach patients the self-regulation of certain unconscious or involuntary physiologic processes. Biofeedback equipment converts physiological signals into outputs given to patients. The technique involves the feedback of a variety of types of information not usually available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiologic process in a specific way. Biofeedback has been proposed as a treatment for a variety of diseases and disorders including anxiety, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud disease, and insomnia. The type of feedback used in an intervention (e.g., visual, auditory) depends on the nature of the disease or disorder being treated.

Biofeedback may be administered, using different techniques and monitoring devices and sensors (e.g., electromyograph), in an outpatient setting by psychiatrists, psychologists, and general practitioners. Biofeedback training is done either in individual or group sessions, alone or in combination with other behavioral therapies designed to teach relaxation. A typical program consists of 10 to 20 training sessions of 30 minutes each. Sessions can take up to 90 minutes. Training sessions are performed in a quiet, nonstimulating environment. Patients are instructed to use mental imagery techniques to affect the physiologic variable being monitored, and feedback is provided for the successful alteration of that physiologic parameter in the form of lights or tone, verbal praise, or other auditory or visual stimuli. This evidence review focuses on the use of biofeedback for the treatment of chronic pain.

Treatment for chronic pain is often multimodal and typically includes psychological therapy. Psychological techniques vary but may include cognitive therapy, which teaches subjects the ability to cope with stressful stimuli by attempting to alter negative thought patterns and dysfunctional attitudes, and behavioral approaches to reduce muscle tension and break the pain cycle. Relaxation, using any of a variety of techniques including meditation or mental imagery, is considered a behavioral therapy that may be used alone or as a component of a cognitive-behavioral therapy program. Electromyography biofeedback has also been used for the treatment of chronic pain, on the assumption that the ability to reduce muscle tension will be improved through the feedback of data to the patient regarding the degree of muscle tension. While some consider electromyography biofeedback to be a method used to obtain relaxation, others consider biofeedback to be distinct from other relaxation techniques.

Electroencephalographic biofeedback, also called neurofeedback, which measures brainwave activity, is addressed in evidence review 20128. Evidence pertaining to the use of biofeedback for chronic insomnia is addressed in evidence review 20128. Evidence pertaining to the use of biofeedback for miscellaneous indications (treatment of hypertension, anxiety, asthma, movement disorders [e.g., motor function after stroke, injury, or lower-limb surgery], and other applications) is addressed in evidence review 20153. Evidence pertaining to the use of biofeedback for headache is addressed in evidence review 20129. Evidence pertaining to the use of biofeedback for urinary incontinence is addressed in evidence review 20127. Evidence pertaining to the use of biofeedback for fecal incontinence or constipation is addressed in evidence review 20164.

Regulatory Status
Since 1976, a large number of biofeedback devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. Food and Drug Administration product code: HCC.

Related Policies
20127 Biofeedback as a Treatment of Urinary Incontinence in Adults
20128 Neurofeedback
20129 Biofeedback as a Treatment of Headache
20153 Biofeedback for Miscellaneous Indications
20164 Biofeedback as a Treatment of Fecal Incontinence or Constipation

Policy:
Biofeedback as a treatment of chronic pain, including, but not limited to, low back pain, is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.  

Biofeedback may be offered as part of a comprehensive program in pain management as offered by pain management centers.

Rationale
The evidence review was created in April 1998 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through Sept. 13, 2023.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, 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 technology, 2 domains are examined: the relevance and quality and credibility. To be relevant, studies must represent 1 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 randomized controlled trial (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.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., people of color [African American, Asian, Black, Latino and Native American]; LGBTQIA [lesbian, gay, bisexual, transgender, queer, intersex, asexual]; women; and people with disabilities [physical and invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Psychological treatments involve both nonspecific and specific therapeutic effects. Nonspecific effects (sometimes called placebo effects) occur as a result of contact with the therapist, positive expectations on the part of the patient and therapist, and other beneficial effects that occur as a result of the patient being in a therapeutic environment. Specific effects are those that occur only because of the active treatment, beyond any nonspecific effects that may be present. This literature review focuses on identifying evidence that the effects of biofeedback are distinct from nonspecific placebo effects. Because establishing an ideal placebo control is problematic with psychological treatments and because treatment of chronic pain is typically multimodal, isolating the specific contribution of biofeedback is challenging.

Biofeedback
Clinical Context and Therapy Purpose
The purpose of electromyography (EMG) biofeedback in individuals who have chronic pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

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

Populations
The relevant population of interest is individuals with chronic pain, including low back, knee, neck and shoulder, orofacial, and abdominal pain as well as fibromyalgia, osteoarthritis, systemic lupus erythematosus, and vulvar vestibulitis.

Interventions
The therapy being considered is EMG biofeedback.

Comparators
The following therapies are currently being used to treat chronic pain: pharmacologic and nonpharmacologic therapy. For chronic pain management, a multimodal, multidisciplinary approach that is individualized to the patient is recommended.¹ A multimodal approach to pain management consists of using treatments (i.e., nonpharmacologic and pharmacologic) from 1 or more clinical disciplines incorporated into an overall treatment plan. This allows for different avenues to address the pain condition, often enabling a synergistic approach that impacts various aspects of pain, including functionality. The efficacy of such a coordinated, integrated approach has been documented to reduce pain severity, improve mood and overall quality of life, and increase function.

Outcomes
The general outcomes of interest are reductions in symptoms and medication usage and improvements in functional outcomes.

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommends that chronic pain trials should consider assessing outcomes representing 6 core domains: pain, physical functioning, emotional functioning, participant ratings of improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition.² Table 1 summarizes provisional benchmarks for interpreting changes in chronic pain clinical trial outcome measures per IMMPACT.³

Table 1. Benchmarks for Interpreting Changes in Chronic Pain Outcome Measures

Outcome Domain and Measure	Type of Improvement	Change
Pain intensity 0 to 10 numeric rating scale	Minimally important Moderately important Substantial	10% to 20% decrease ≥ 30% decrease ≥ 50% decrease
Physical functioning Multidimensional Pain Inventory Interference Scale Brief Pain Inventory Interference Scale	Clinically important Minimally important	≥ 0.6 point decrease 1 point decrease
Emotional functioning Beck Depression Inventory Profile of Mood States Total Mood Disturbance Specific Subscales	Clinically important Clinically important Clinically important	≥ 5 point decrease ≥ 10 to 15 point decrease ≥ 2 to 12 point change
Global Rating of Improvement Patient Global Impression of Change	Minimally important Moderately important Substantial	Minimally improved Much improved Very much improved

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 adverse events, 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
General Chronic Pain
Systematic Reviews
Several meta-analyses have reviewed RCTs assessing psychological therapies for a variety of non-headache chronic pain conditions. A Cochrane review by Williams et al. (2020) focused on chronic pain in adults.⁴ Two RCTs were identified that compared behavioral therapy with an active control designed to change behavior (i.e., exercise or instruction). Three RCTs had sufficient follow-up to be included in a comparison of behavioral therapy and usual treatment. Reviewers found no evidence that behavioral therapy had any effect on pain compared to active control or usual treatment. Additionally, there was no evidence of a difference between behavioral therapy and active control or usual treatment in terms of disability at the end of treatment.

Another Cochrane review by Fisher et al. (2018) focused on children and adolescents with chronic and recurrent pain.⁵ Although psychological therapies were found to improve pain, only 1 study evaluated biofeedback in nonheadache pain. Biofeedback did not improve abdominal pain more than cognitive-behavioral therapy (CBT) in this trial;⁶ see the section on Abdominal Pain. Palermo et al. (2010) published a meta-analysis of studies on psychological therapies for the management of chronic pain in children and adolescents.⁷ These authors did not identify any additional RCTs on biofeedback for managing non-headache pain.

Low Back Pain
Systematic Reviews
A Cochrane review by Henschke et al. (2010) assessed behavioral treatments for chronic low back pain and conducted a meta-analysis of 3 small randomized trials that compared EMG biofeedback with a waiting-list control group.⁸ In the pooled analysis, there were a total of 34 patients in the intervention group and 30 patients in the control group. The standardized mean difference (SMD) in short-term pain was -0.80 (95% confidence interval [CI], -1.32 to -0.28); this difference was statistically significant favoring the biofeedback group. Reviewers did not conduct meta-analyses of trials comparing biofeedback with sham biofeedback and therefore were unable to control for any nonspecific effects of treatment.

Randomized Controlled Trials
At least 1 RCT has compared biofeedback with a sham intervention for the treatment of low back pain. Kapitza et al. (2010) compared the efficacy of respiratory biofeedback with sham biofeedback in 42 patients with low back pain.⁹ Both groups showed a reduction in pain levels on a 10-point visual analog scale (VAS) at the end of the intervention period and at 3-month follow-up. Between-group differences were not statistically significant. For example, 3 months after the intervention, mean change in pain with activity decreased by 1.12 points in the intervention group and 0.96 points in the sham control group (p>.05); mean change in pain at rest decreased by 0.79 points in the intervention group and 0.49 points in the control group (p > .05).

Lazaridou et al. (2023) conducted a prospective, single-center RCT to assess the impact of surface EMG biofeedback versus continued care (no intervention) on chronic lower back pain in adults.¹⁰ Sixty-six patients were randomized 2:1 to receive EMG biofeedback or no additional intervention for 8 weeks and included in analysis. Compared to usual care, patients receiving EMG biofeedback reported lower pain intensity on the Brief Pain Inventory (BPI) questionnaire after 8 weeks (mean difference [MD], 0.9; 95% CI, -1.07 to -0.32; p ≤ .01). Compared to baseline scores, individuals in the EMG biofeedback group demonstrated statistically significant reductions in pain interference (MD, 1.3; 95% CI, 0.42 to 2.1; p ≤ .01), disability (MD, 4.32; 95% CI, 1.2 to 7.3; p ≤ .01), and significant increases in low back pain thresholds (MD, 0.5; 95% CI, -0.87 to -0.05; p ≤ .01). Significant changes were also observed in muscle tension for the lower back muscles in the EMG biofeedback group (p < .001).

Several trials with active comparison groups have not found that biofeedback is superior to alternative treatments. Tan et al. (2015) evaluated 3 self-hypnosis interventions and included EMG biofeedback as a control intervention.¹¹ This RCT enrolled 100 patients with chronic low back pain. After the 8-week intervention, reported reductions in pain intensity were significantly higher in the combined hypnosis groups than in the biofeedback group (p = .042).

A trial published by Glombiewski et al. (2010) assessed whether the addition of EMG biofeedback to CBT improved outcomes in 128 patients with low back pain.¹² Patients were randomized to 1 of 3 groups: CBT, CBT plus biofeedback, or waiting-list control. Both treatments improved outcomes including pain intensity compared with the waiting-list control (moderate effect size of 0.66 for pain intensity in the CBT plus biofeedback group). However, the addition of biofeedback did not improve outcomes over CBT alone.

Chronic Knee Pain
Systematic Reviews
Karaborklu Argut et al. (2022) conducted a systematic review of 8 RCTs of patients who had undergone orthopedic knee surgery.¹³ Therapeutic EMG biofeedback during rehabilitation was more effective for improving muscle strength and activation compared to home exercise, standard rehabilitation, or electrical stimulation. There were no clear trends in the effect of EMG biofeedback on pain or knee range of motion.

Collins et al. (2012) conducted a systematic review and meta-analysis of RCTs on nonsurgical interventions for anterior knee pain.¹⁴ In a pooled analysis of data from 2 trials, there was no significant benefit of adding EMG biofeedback to an exercise-only intervention at 8 to 12 weeks (SMD, -0.22; 95% CI, -0.65 to 0.20).

Chronic Neck and Shoulder Pain
Systematic Reviews
Campo et al. (2021) published a systematic review and meta-analysis that evaluated the effectiveness of biofeedback for improving pain, disability, and work ability in adults with neck pain.¹⁵ The review included 15 RCTs with 8 studies utilizing EMG biofeedback and 7 studies of pressure biofeedback (Table 2). There was no restriction on the control intervention (e.g., no treatment, placebo, active treatment) or co-intervention, provided the independent effects of biofeedback could be elucidated. An overview of the characteristics and results is presented in Tables 3 and 4. Results suggest that biofeedback has a moderate effect on reducing short-term disability and a small effect on reducing intermediate-term disability with no effect on pain or work ability in the short- and intermediate-term. Of note, there were a variety of control interventions across included studies (e.g., exercise, electroacupuncture, electrotherapy, education) with few studies directly comparing biofeedback to no treatment or placebo.

Kamonseki et al. (2021) completed a systematic review and meta-analysis of 5 RCTs that examined the effects of EMG biofeedback for shoulder pain and function.¹⁶ Study characteristics and results are presented in Tables 3 and 4. Overall, the evidence did not support the use of EMG biofeedback for reducing shoulder pain and improving shoulder function.

Table 2. Comparison of Studies Included in Systematic Reviews and Meta-Analyses

Study	Campo et al. (2021)15	Kamonseki et al. (2021)16
Juul-Kristensen et al. (2019)17		⚫
Kosterink et al. (2010)18	⚫	⚫
Ma et al. (2011)19	⚫	⚫
Middaugh et al. (2013)20		⚫
Sandsjo et al. (2010)21	⚫	⚫
Arami et al. (2012)22	⚫
Bissett et al. (1985)23	⚫
Bobos et al. (2016)24	⚫
Delive et al. (2011)25	⚫
Ehrenborg et al. (2010)26	⚫
Eslamian et al. (2020)27	⚫
Iqbal et al. (2013)28	⚫
Jull et al. (2002)29	⚫
Jull et al. (2007)30	⚫
Nezamuddin et al. (2013)31	⚫
Voerman et al. (2007)32	⚫
Wani et al. (2013)33	⚫

Table 3. Systematic Review and Meta-Analysis Characteristics

Study	Dates	Trials	Participants	N (Range)	Design	Duration
Campo et al. (2021)15	To Sept 2020	15	Adults with neck pain including pain associated with radiculopathy, cervicogenic headaches, whiplash, shoulder pain, and work-related injuries administered biofeedback (EMG or pressure) on at least 2 occasions	990 (27 to 200)	RCT (8 studies EMG; 7 pressure)	8 days to 6 weeks (duration of interventions)
Kamonseki et al. (2021)16	To Dec 2020	5	Adults with shoulder pain	272 (15 to 72)	RCT (all EMG)	4 weeks to 6 months (follow-up period)

EMG: electromyography; RCT: randomized controlled trial.

Table 4. Systematic Review and Meta-Analysis Results

Study	Pain (short-term: 4 to 6 weeks)	Pain (intermediate-term: 8 to 12 weeks)	Disability (short-term: 4 to 6 weeks)	Disability (intermediate-term: 8 to 12 weeks)	Work ability (short-term: 4 to 6 weeks)	Work ability (intermediate-term: 8 to 12 weeks)
Campo et al. (2021)15
Total N	602 (11 RCTs)	383 (6 RCTs)	627 (9 RCTs)	458 (5 RCTs)	190 (3 RCTs)	190 (3 RCTs)
Between-group difference in SMC (95% CI)	-0.26 (-0.77 to 0.24)	-0.15 (-0.34 to 0.05)	-0.42 (-0.59 to -0.26)	-0.30 (-0.53 to -0.06)	-0.01 (-0.26 to 0.28)	-0.03 (-0.26 to 0.31)
Certainty of Evidencea	Moderate	Low	Moderate	Moderate	Low	Low
Kamonseki et al. (2021)16
	Shoulder pain intensity	Shoulder function
Total N	250 (5 RCTs)	175 (3 RCTs)
SMD (95% CI)	-0.21 (-0.67 to 0.34)	-0.11 (-0.41 to 0.19)
p value (I2)	.36 (65%)	.48 (0%)
Quality of Evidencea	Very low	Very low

CI: confidence interval; RCT: randomized controlled trial; SMC: standardized mean change; SMD: standardized mean difference.
^a High certainty: we are very confident that the true effect lies close to that of the estimate of the effect; moderate certainty: we are moderately confident in the effect estimate.; low certainty: our confidence in the effect estimate is limited; very low certainty: we have very little confidence in the effect estimate.

Randomized Controlled Trial
de Oliveira et al. (2022) conducted an RCT in 24 patients with subacromial pain syndrome who received exercise or exercise plus EMG biofeedback for 8 weeks.³⁴ The primary outcomes were pain and shoulder function. At 8 weeks, pain was better in the exercise-only group (mean numeric pain rating, 0.5 vs 2 with exercise plus biofeedback; p = .01); however, this outcome was not different between groups at other time points. The only other significant finding was forward rotation of the scapula, which was better in the biofeedback group at 12 weeks (p = .006). All other outcomes were similar between groups.

Ribeiro and Silva (2019) published an RCT assessing whether visual feedback improves range of motion in patients with chronic idiopathic neck pain.³⁵ Forty-two patients from a single Portuguese clinic were included in the study and randomly assigned to either the visual feedback group (n = 21) or the control group (n = 21). There was no effect of time and intervention on pain intensity (p = .729), but there was a significant interaction between time and intervention in neck flexion (p < .001). The study was limited by its small sample size, short duration of intervention, and by the researcher assessing patients not being blinded.

Orofacial Pain
Systematic Reviews
A Cochrane review by Aggarwal et al. (2011) identified 17 trials evaluating nonpharmacologic psychological interventions for adults with chronic orofacial pain (e.g., temporomandibular joint disorder).³⁶ For studies reporting on short-term pain relief (≤ 3 months), a significantly greater reduction in pain was found for interventions that combined CBT plus biofeedback compared with usual care (2 studies; SMD, 0.46; 95% CI, 0.02 to 0.90). However, when reviewers assessed results from studies reporting on long-term pain relief (≥ 6 months), no significant benefit was found with a combined intervention of CBT plus biofeedback, and there were no studies that compared CBT alone with CBT plus biofeedback. For studies reporting on biofeedback-only interventions, a pooled analysis of 2 studies on short-term pain relief did not find a significant benefit compared with usual care (SMD, -0.41; 95% CI, -1.06 to 0.25). Only 1 study reported long-term pain relief after a biofeedback-only intervention, so a pooled analysis could not be done. Reviewers concluded that there was weak evidence to support psychosocial interventions for managing chronic orofacial pain and the most promising evidence was for CBT, with or without biofeedback. The authors noted that the trials comprising the review were few in number and had a high-risk of bias.

The conclusions drawn from this Cochrane review are similar to those of earlier systematic reviews on the treatment of temporomandibular joint disorder.^37,38 These older reviews also concluded that there was weak evidence that psychosocial/physical therapy interventions (including biofeedback) are beneficial for treating temporomandibular joint disorder and that, of the few studies available, they tended to be of poor methodologic quality.

Abdominal Pain
Systematic Reviews
In a systematic review of therapies for recurrent abdominal pain in children by Weydert et al. (2003), the behavioral interventions of CBT and biofeedback had a generally positive effect on nonspecific recurrent abdominal pain and were deemed safe.³⁹ The specific effects of biofeedback were not isolated in this systematic review and therefore cannot be assessed.

Randomized Controlled Trials
In a study by Humphreys and Gevirtz (2000), 64 children and teenagers diagnosed with recurrent abdominal pain were randomized to groups treated with increased dietary fiber; fiber and biofeedback; fiber, biofeedback, and CBT; or fiber, biofeedback, CBT, and parental support.⁶ The similar nature of the 3 multicomponent treatment groups was associated with greater pain reduction than the fiber-only group. This trial did not address placebo effects.

Fibromyalgia
Systematic Reviews
Glombiewski et al. (2013) published a systemic review and meta-analysis of RCTs reporting data on the efficacy of EMG and electroencephalography (EEG) biofeedback (i.e., neurofeedback) for treating patients with fibromyalgia.⁴⁰ Reviewers identified 7 RCTs that compared biofeedback with a control method in patients with fibromyalgia. Studies in which biofeedback was evaluated only as part of multicomponent interventions were excluded. Three studies used EEG biofeedback and 4 used EMG biofeedback (N = 321 patients). A sham intervention was used as a control condition in 4 studies, 2 using EEG biofeedback and 2 using EMG biofeedback. In a pooled analysis of the studies using EMG biofeedback, a significant reduction in pain intensity was found compared with a different intervention (effect size, Hedges g = 0.86; 95% CI, 0.11 to 0.62). A pooled analysis of studies on EEG biofeedback did not find a significant benefit in pain reduction compared with control methods. Pooled analyses of studies of EMG and EEG biofeedback did not find a significant benefit of either intervention on other outcomes such as sleep problems, depression, and health-related quality of life. None of the studies reviewed were of high quality, with the risk of bias assessed as unclear or high for all included studies. In addition, all studies reported short-term outcomes, resulting in a lack of evidence on whether longer-term outcomes improved with these interventions. (For more information on EEG biofeedback, see evidence review 2.01.28.)

Randomized Controlled Trials
In a small, double-blind RCT from Asia, Babu et al. (2007) compared actual and sham biofeedback for effects on pain, fitness, function, and tender points in 30 patients with fibromyalgia.⁴¹ Pain reduction, as assessed on a VAS, did not differ significantly between groups. The trialists calculated that a sample size of 15 patients could detect a difference of 5 cm (on a 10-cm scale) on a VAS, suggesting that the trial lacked adequate power.

A larger unblinded RCT by van Santen et al. (2002) evaluated 143 women with fibromyalgia, and compared EMG biofeedback with fitness training and usual care.⁴² The primary outcome was pain measured on a VAS. Compared with usual care, the investigators reported no clear improvements in objective or subjective patient outcomes with biofeedback (or fitness training).

Another RCT on EMG biofeedback for fibromyalgia was conducted by Buckelew et al. (1998), and enrolled 119 patients; however, the trial did not follow a double-blind design.⁴³ Patients were randomized to 1 of 4 treatment groups: (1) biofeedback/relaxation training, (2) exercise training, (3) combination treatment, and (4) an educational/attention control program. While the combination treatment group had better tender point index scores than other treatment groups, this trial did not address placebo effects or the impact of adding biofeedback to relaxation therapy.

Osteoarthritis
Systematic Reviews
A systematic review by Macfarlane et al. (2012) evaluated practitioner-based complementary and alternative medicine treatments (defined as any treatment not taken orally or applied topically) for osteoarthritis and identified 2 trials on biofeedback.⁴⁴ One was an RCT by Yilmaz et al. (2010) that assessed whether the addition of EMG biofeedback to strengthening exercises improved outcomes in 40 patients with knee osteoarthritis.⁴⁵ After a 3-week treatment period, no significant differences between the 2 treatments regarding pain or quality of life were found. The other RCT, by Durmus et al. (2007), compared electrical stimulation with biofeedback-assisted exercise in 50 women with knee osteoarthritis.⁴⁶ After 4 weeks of treatment, there were no statistically significant differences between groups in pain and functioning scores.

Systemic Lupus Erythematosus
Randomized Controlled Trials
In an RCT by Greco et al. (2004), of 92 patients with systemic lupus erythematosus, those treated with 6 sessions of biofeedback-assisted CBT for stress reduction had statistically greater reductions in pain posttreatment than a symptom-monitoring support group (p = .044) and a group receiving usual care (p = .028).⁴⁷ However, these reductions in pain were not sustained at a 9-month follow-up.

Vulvar Vestibulitis
Randomized Controlled Trials
A randomized study by Bergeron et al. (2001) of 78 patients with dyspareunia resulting from vulvar vestibulitis compared treatment with EMG biofeedback, surgery, or CBT.⁴⁸ Patients who underwent surgery had significantly lower pain scores than patients who received biofeedback or CBT. No placebo treatment was used.

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

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.

American College of Occupational and Environmental Medicine
In 2020, the American College of Occupational and Environmental Medicine updated their guideline on noninvasive and minimally invasive management of low back disorders.⁴⁹ The role of biofeedback is not addressed in this updated guideline.

American College of Physicians
In 2017, the American College of Physicians issued practice guidelines on noninvasive treatments for acute, subacute, and chronic low back pain.⁵⁰ For patients with chronic low back pain, the guidelines recommended that initial treatment should be nonpharmacologic, such as "exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavior therapy or spinal manipulation" (strong recommendation).

American Society of Anesthesiologists & American Society of Regional Anesthesia and Pain Medicine
In 2010, practice guidelines from the American Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine suggested that "cognitive behavioral therapy, biofeedback, or relaxation training....may be used as part of a multimodal strategy for patients with low back pain, as well as for other chronic pain conditions."⁵¹

North American Spine Society
In 2020, the North American Spine Society published a guideline for the diagnosis and treatment of low back pain.⁵² Although nonpharmacologic therapies are addressed in this guideline, the specific role of biofeedback for low back pain is not addressed.

U.S. Department of Veterans Affairs and U.S. Department of Defense
In 2022, the U.S. Department of Veterans Affairs and U.S. Department of Defense updated their guideline on the diagnosis and treatment of low back pain.⁵³ The guideline recommends several nonpharmacologic therapies for chronic low back pain (e.g., cognitive-behavioral therapy [CBT] and/or mindfulness-based stress reduction, progressive relaxation, exercise including yoga, pilates, and tai chi) but does not address the role of biofeedback.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Current ongoing and unpublished clinical trials that might influence this review are listed in Table 5.

Table 5. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT04607460	Biofeedback EMG Alternative Therapy for Chronic Low Back Pain and Chronic Cancer Pain (BEAT-Pain): A Pilot Efficacy Study	330	Dec 2023
NCT04197284	Comparison of Efficacy of Biofeedback, Electrical Stimulation and Therapeutic Exercise in Patients With Knee Osteoarthritis	93	Jun 2022 (unknown)
NCT05425121	Effects of Core Stability Exercises With Surface Electromyography Biofeedback on Postural Stability and Sensory Integration of Balance in Patients With Mechanical Low Back Pain	52	Dec 2024

NCT: national clinical trial.

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Coding Section

Codes	Number	Description
CPT	90875-90876	Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (e.g., insight oriented, behavior modifying or supportive sychotherapy); code range
	90901	Biofeedback training by any modality
ICD-9 Procedure	94.39	Other individual psychotherapy (includes biofeedback)
ICD-9 Diagnosis		Investigational for all codes
HCPCS	E0746	Electromyography (EMG), biofeedback device
ICD-10-CM (effective 10/01/15)		Investigational for all codes
	G56.40-G56.42	Causalgia of upper limb code range
	G57.70-G57.72	Causalgia of lower limb code range
	G89.0-G89.4	Pain, not elsewhere classified code range
	G90.50-G90.59	Complex regional pain syndrome I code range
	M25.50-M25.579	Pain in joint code range
	M54.00-M54.9	Dorsalgia code range
	M79.60-M79.676	Pain in limb, hand, foot, fingers and toes code range
	R52	Pain, unspecified
ICD-10-PCS (effective 10/01/15)		ICD-10-PCS codes are only for use on inpatient services.
	GZC9ZZZ	Mental health, none, other biofeedback
Type of Service	Medicine
Place of Service	Physician Office

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, 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     

04/01/2024	Annual review, no change to policy intent. Updating rationale and references.
04/01/2023	Annual review, no change to policy intent. Updating rationale and references
04/01/2022	Annual review, no change to policy intent. Updating background, rationale and references.
04/01/2021	Annual review, no change to policy intent. Updating background, rationale and references.
04/01/2020	Annual review, no change to policy intent. Updating description, regulatory status, rationale and references.
04/01/2019	Annual review, no change to policy intent. Updating rationale and references.
04/18/2018	Annual review, no change to policy intent. Updating rationale and references.
04/03/2017	Annual review, no change to policy intent.
04/07/2016	Annual review, no change to policy intent. Updated background, description, rationale and references.
04/16/2015	Annual review, no change to policy intent. Updated background, description, rationale, references. Added coding and regulatory status.
04/09/2014	Annual review. Updated related policies, benefit application, rationale and references. No change to policy intent.