Description
Dry hydrotherapy, also known as hydromassage or aquamassage, is a massage treatment modality that circulates heated, pressurized water in a self-contained device such as a bed or chair. The individual remains clothed and dry as they sit or lie on top of a waterproof barrier containing rotating and pulsating interior jets. Purported benefits of dry hydrotherapy include alleviation of pain, increased blood circulation, improved range of motion, and decreased need for other interventions.

Background
Dry Hydrotherapy
Dry hydrotherapy, also known as hydromassage or aquamassage, is a massage treatment modality that circulates streams of heated, pressurized water in a self-contained device such as a bed or chair. The individual remains clothed and dry as they sit or lie on top of a waterproof barrier containing rotating and pulsating interior jets. Purported benefits of dry hydrotherapy include alleviation of pain, increased blood circulation, improved range of motion, deep relaxation, and reduction of stress and anxiety. Use of dry hydrotherapy has also been suggested to reduce the need for other interventions, by combining the effects of traditional wet hydrotherapy, massage therapy, acupressure, heat therapy, soft tissue manipulation, and trigger point therapy without the need for additional health staff.

Specific physiological effects claimed on the Sidmar manufacturer site for its hydromassage tables include purported physiological effects stemming from application of radiant heat and massage.¹ Purported physiologic effects of radiant heat include analgesic, antispasmodic, decongestive, sedative, and vasodilatory properties, leading to reduced pain, increased relaxation, enhanced capillary blood flow, decreased spasticity, tenderness, and spasm, and increased rates of healing. Purported benefits of massage include increased local blood supply, increased lymphatic drainage and reduction of swelling, muscle relaxation, prevention of adhesions and fibrosis, decreased tendency toward muscle atrophy, and pain reduction and increased ease of mobility.

Regulatory Status
Dry hydrotherapy devices are classified by the U.S. Food and Drug Administration (FDA) as class I therapeutic massagers, which are defined as electrically powered devices intended for medical purposes, such as to relieve minor muscle aches and pains. Class I devices are exempt from 510(k) requirements and do not require submission of clinical data regarding efficacy but only notification of FDA prior to marketing (FDA Product Code: ISA; Sec. 890.5660).

Dry hydrotherapy does not involve water immersion and should not be confused with immersion hydromassage baths or powered sitz baths (FDA Product Code: ILJ; Sec. 890.5100).

Examples of currently marketed dry hydrotherapy devices include but may not be limited to HydroMassage branded (previously AquaMED) beds and loungers (JTL Enterprises Inc.),² Massage Time Pro S10 or ComfortWave S10 branded hydromassage tables (Sidmar Manufacturing Inc.),³ and SolaJet^® Dry-Hydrotherapy Systems.⁴ 

Policy 
The use of dry hydrotherapy massagers for the treatment of chronic pain conditions is investigational/unproven therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines
Coding 
See the Codes table for details.

Benefit Application
BlueCard/National Account Issues
Dry hydrotherapy may be offered as part of a comprehensive program in pain management as offered by pain management, chiropractic, or physical therapy centers.

Rationale
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, 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 a technology, 2 domains are examined: the relevance and the 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.

Dry Hydrotherapy for Chronic Pain Conditions
Clinical Context and Therapy Purpose
The purpose of dry hydrotherapy is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with chronic pain conditions (e.g., musculoskeletal, neuropathic, and mixed pain conditions).

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

Populations
The relevant population(s) of interest is individuals with chronic pain conditions (e.g., musculoskeletal, neuropathic, or mixed pain conditions).

Interventions
The therapy being considered is non-immersive dry hydrotherapy. A session of dry hydrotherapy may be tailored to the individual in terms of temperature, intensity, localization, and duration, and is typically delivered in increments of 15 to 30 minutes. Regular sessions of at least once or twice a week have been recommended for full benefits. Dry hydrotherapy is typically delivered in a supine or seated position with bed (i.e., 'table') or chair (i.e., 'lounge') device models, respectively. For hydrotherapy bed models, patient position can be further manipulated to target treatment to affected sites.

Comparators
The following interventions are currently being used to treat chronic pain conditions: physical therapy, pharmacotherapy, and other conservative therapies.

Outcomes
The general outcomes of interest are symptoms (e.g., visual analog scale [VAS] for change in pain intensity), functional outcomes (e.g., range of motion), quality of life, medication use, and health resource utilization. Follow-up over months is of interest to monitor for outcomes in chronic pain conditions.

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.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
No peer-reviewed studies on the use of dry hydrotherapy in individuals with chronic pain conditions were identified.

Health Technology Assessments
In 1998, the Washington State Department of Labor & Industries released a technology assessment on the AquaMED dry hydrotherapy unit distributed by JTL Enterprises.⁵ Reviewers did not identify any peer-reviewed publications and summarized limited data reported on the original AquaMED website, including partial excerpts from a masters thesis from the University of West Florida psychology department, measurements from paraspinal scans from 10 patients before and after treatment, conclusions of ultrasound imaging of 20 patients before and after treatment, and results of thermographic imaging on 4 patients before and after therapy. The reviewers also noted that they could not identify any published research that supports claims that dry hydrotherapy can take the place of multiple modalities (e.g., heat packs, wet hydrotherapy, massage and/or soft tissue manipulation) or that it provides any durable benefits.

Notably, JTL Enterprises, the parent company of both AquaMED and HydroMassage dry hydrotherapy units, announced a brand integration to market both devices under the HydroMassage brand in 2009.⁶ In January 2020, the HydroMassage website listed a disclaimer stating that "all benefits of HydroMassage are temporary and apply only to the areas massaged. HydroMassage does not claim to cure or heal any conditions."⁷ Manufacturer-provided clinical data previously shared on the AquaMED website is no longer available.

Section Summary: Dry Hydrotherapy for Chronic Pain Conditions
No published, peer-reviewed literature was identified evaluating the use of dry hydrotherapy in individuals with chronic pain conditions. A technology assessment for the AquaMED device released from the Washington State Department of Labor & Industries in 1998 concluded that it could not identify any published research that supports claims that dry hydrotherapy can take the place of multiple modalities or that it provides any durable health benefits. Well-conducted studies comparing dry hydrotherapy to established interventions for chronic pain conditions are required to evaluate health outcomes.

Summary of Evidence
For individuals with chronic pain conditions (e.g., musculoskeletal, neuropathic, and mixed pain conditions) who receive dry hydrotherapy, there are no published, peer-reviewed studies. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and resource utilization. A health technology assessment released in 1998 for the AquaMED device also failed to identify published research to support claims that dry hydrotherapy can take the place of multiple modalities or that it provides any durable health benefits. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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.

National Institute for Health and Care Excellence
In 2017, the National Institute for Health and Care Excellence (NICE) published a guidance on the diagnosis and management of spondyloarthritis in individuals over 16 years of age.⁸ The guidance recommends consideration of hydrotherapy as an adjunctive therapy to manage pain or improve function for individuals with axial spondyloarthritis. However, it is unclear whether this recommendation applies to the use of dry hydrotherapy.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in May 2022 did not identify any ongoing or unpublished trials that would likely influence this review.

References

1. Sidmar. Healthcare Data. 2022; https://sidmar.com/healthcare/healthcare-data/. Accessed May 20, 2022.
2. HydroMassage. Featured Products. 2022; https://www.hydromassage.com/products/. Accessed May 20, 2022.
3. Sidmar. Shop. 2022; https://sidmar.com/shop/. Accessed May 19, 2022.
4. SolaJet. The SolaJet. 2021; https://www.solajet.com/products. Accessed May 20, 2022.
5. Washington State Department of Labor & Industries. AquaMED Technology Assessment. 1998; https://www.lni.wa.gov/patient-care/treating-patients/treatment-guidelines-and-resources/_docs/AquaMedTA.pdf. Accessed May 20, 2022.
6. Chiropractic Economics. AquaMED and HydroMassage announce brand integration. January 28, 2009; https://www.chiroeco.com/aquamed-and-hydromassage-announce-brand-integration/. Accessed May 20, 2022.
7. HydroMassage. HydroMassage Benefits: Ways Water Massage Can Improve Wellness & Recovery. January 20, 2022; https://www.hydromassage.com/blog/hydromassage-benefits-for-wellness-recovery/. Accessed May 19, 2022.
8. National Institute for Health and Care Excellence (NICE). NICE guideline [NG65]. Spondyloarthritis in over 16s: diagnosis and management. February 28, 2017; https://www.nice.org.uk/guidance/ng65. Accessed May 20, 2022.

Coding Section

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" 

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