Medical Policy

Policy Num:      08.001.060
Policy Name:    Dry Hydrotherapy for Chronic Pain Conditions
Policy ID:          [08.001.060]  [Ac / B / M- / P-]  [2.01.105]

Last Review:      December 12, 2024
Next Review:      December 20, 2025
 

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08.001.007 - Dry Needling of Trigger Points for Myofascial Pain
02.001.103 - Trigger Point and Tender Point Injections
02.001.031 - Biofeedback as a Treatment of Chronic Pain
02.001.015 - Paraspinal Surface Electromyography to Evaluate and Monitor Back Pain
02.001.077 - Epidural Steroid Injections for Back Pain
05.001.014 - Intravenous Anesthetics for the Treatment of Chronic Pain and Psychiatric Disorders
05.001.037 - Medical Cannabis for the Treatment of Pain and Spasticity
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08.001.011 - Manipulation Under Anesthesia

Dry Hydrotherapy for Chronic Pain Conditions

Summary

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.

Summary of Evidence

For individuals with chronic pain conditions (eg, 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.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine whether the use of dry hydrotherapy improves the net health outcome in individuals with chronic pain conditions.

Policy Statements

The use of dry hydrotherapy massagers for the treatment of chronic pain conditions is considered investigational.

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.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

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.), Pro S10 or ComfortWave S10 branded hydromassage tables (Sidmar Manufacturing Inc.), and SolaJet® Dry-Hydrotherapy Systems.

Rationale

This evidence review was created in May 2022 with a search of the PubMed database. The most recent literature update was performed through October 28, 2024.

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.

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.

Population Reference No. 1

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 individuals with chronic pain conditions (eg, 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 (eg, 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 (ie, 'table') or chair (ie, 'lounge') device models, respectively. For hydrotherapy bed models, individual 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 (eg, visual analog scale [VAS] for change in pain intensity), functional outcomes (eg, 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.^2, 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 (eg, 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.^3, 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."^4, 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.

For individuals with chronic pain conditions (eg, 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.

Supplemental Information

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 US professional society, an international society with US 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.^5, 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.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in October 2024 did not identify any ongoing or unpublished trials that would likely influence this review.

References

1. Sidmar. Healthcare Data. 2023; https://sidmar.com/healthcare/healthcare-data/. Accessed October 28, 2024.
2. 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 October 28, 2024.
3. Chiropractic Economics. AquaMED and HydroMassage announce brand integration. January 28, 2009; https://www.chiroeco.com/aquamed-and-hydromassage-announce-brand-integration/. Accessed October 28, 2024.
4. HydroMassage. HydroMassage Benefits: Ways Water Massage Can Improve Wellness & Recovery. January 20, 2022; https://www.hydromassage.com/blog/hydromassage-benefits-for-wellness-recovery/. Accessed October 28, 2024.
5. 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 October 28, 2024.

Codes

Policy History