Coverage Policy Manual
Policy #: 2023006
Category: Medicine
Initiated: May 2023
Last Review: February 2024
  Stationary Ultrasonic Diathermy Devices
Description:
An ultrasonic diathermy device applies ultrasonic energy to specific body parts at a frequency higher than 20 kilohertz in order to generate deep heat within body tissues for the treatment of certain medical conditions, such as the alleviation of pain, muscle spasms, and joint contractures. Newer portable stationary devices can be self-applied and used at home to deliver diathermy via continuous low-intensity therapeutic ultrasound. Electrodes attached to adhesive bandages are applied to the skin over the desired treatment area. The continuous low-intensity ultrasound unit can provide treatment for several hours.
 
Therapeutic Ultrasound
Therapeutic ultrasound is a noninvasive method used to treat a variety of musculoskeletal conditions (FDA, 2020). Therapeutic ultrasound produces acoustic vibrations of high frequency (≥20 kilohertz) that are outside the range of human hearing (Matthews, 2022). The vibrations generated during therapeutic ultrasound allow the body to generate heat in targeted tissues that are high in collagen (muscles, tendons, ligaments, etc); this is referred to as ultrasound/ultrasonic diathermy. The increased vibrations and heat to the affected areas simulate soft tissue injury repair and pain relief.
 
Conventionally, high-frequency/high-intensity therapeutic ultrasound is provided in a clinic setting with an average length of treatment ranging from 5 to 10 minutes per session (FDA, 2020; Matthews, 2022). In this setting, the ultrasound is transmitted through a wand that is applied to the skin with gentle, circular movements. A hypo-allergenic gel aids in the transmission of ultrasonic energy and prevents overheating at the surface of the applicator.
 
It is important to note that individuals with implanted metal devices, including pacemakers, prostheses, and intrauterine devices, are at risk of serious injury if they undergo diathermy (FDA, 2020). Furthermore, patients with certain medical conditions, including cancer and others, may not be appropriate candidates for diathermy.
 
Ultrasonic Diathermy Devices
Newer portable/wearable, stationary devices can be used at home to deliver diathermy via continuous low-intensity therapeutic ultrasound (Uddin, 2021). Electrodes attached to adhesive bandages are self-applied to the skin over the desired treatment area. This type of treatment may also be referred to as sustained acoustic medicine. Similar to conventional high-frequency/high-intensity therapeutic ultrasound, a high-frequency/low-intensity ultrasonic diathermy device applies ultrasonic energy to specific body parts in order to generate deep heat within body tissues for the treatment of certain medical conditions, such as the alleviation of pain, muscle spasms, and joint contractures. The continuous low-intensity ultrasound device provides treatment for several hours.
 
Regulatory Status
Several stationary ultrasonic diathermy devices have been granted 510(k) clearance by the United States Food and Drug Administration (FDA) including Manasport™ (ManaMed, Inc., Las Vegas, NV), Sustained Acoustic Medicine (sam®) (ZetrOZ™, Inc., Trumbull, CT), and PainShield™ MD (NanoVibronix Inc., Elmsford, NY). The intended use of these devices is to supply ultrasound “to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, muscle spasms, joint contractures, and increase local circulation.”
 
FDA product code: PFW
Policy/
Coverage:
Effective May 2023
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Ultrasonic diathermy devices for the treatment of musculoskeletal pain do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, ultrasonic diathermy devices for the treatment of musculoskeletal pain are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
This evidence review was created in October 2022 with a search of the PubMed database. The most recent literature update was performed through October 24, 2022.
 
Musculoskeletal Pain
The purpose of stationary ultrasonic diathermy devices in patients who have musculoskeletal pain is to provide a treatment option that is an alternative to or an improvement on existing therapies. For chronic pain management, a multimodal, multidisciplinary approach that is individualized to the patient is recommended (U.S. Department of HHS, 2019). 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.
 
Systematic Reviews
A systematic review evaluating the clinical effects of stationary ultrasonic diathermy devices on musculoskeletal conditions was conducted by Winkler et al (Winkler, 2022). Winkler et al summarized the clinical effects of the sustained acoustic medicine (sam®) device versus placebo control in individuals with musculoskeletal injuries (Winkler, 2021). The analysis included 13 studies divided into 3 treatment areas: upper shoulder, neck, and back (3 studies); knee joint (4 studies); and soft tissue injuries of the musculoskeletal system (6 studies). The following clinical outcomes were evaluated: pain, function, and diathermy. Overall, therapy with a SAM device reduced pain, improved overall health quality, and generated deep therapeutic heat. Limitations of this analysis included heterogeneity in treatment area, therapy implementation, and clinical outcomes, small sample sizes, and short follow-up.
 
Randomized Controlled Trials
There are no RCTs published after the Winkler et al systematic review evaluating the clinical effects of stationary ultrasonic diathermy devices on musculoskeletal pain.
 
Six RCTs were included in the Winkler review (Lewis et al [2013], Petterson et al [2020], Langer et al [2015], Draper et al [2018], Rigby et al [2015], and Langer et al [2017]), of which 3 were rated as "excellent quality" using the Downs and Black checklist for quality evaluation of RCTs and non-RCTs (Lewis, 2013; Petterson, 2020; Langer, 2015; Draper, 2018; Rigby, 2015; Langer, 2017). Three studies were rated as "excellent quality" (Petterson, 2020; Draper, 2018; Langer, 2017). In 2 of these RCTS, treatment with a SAM device for 4 hours daily for 4 to 6 weeks demonstrated improvements in pain scores in individuals with upper trapezius myofascial pain and mild to moderate knee osteoarthritis with moderate to severe associated pain (Petterson, 2020; Draper, 2018). Limitations of the available data include heterogeneity in treatment areas, treatment implementation, and clinical outcomes, small sample sizes, and short follow-up. The third study rated as excellent quality (Langer et al [2017]) was done in healthy individuals and did not evaluate relevant clinical outcomes (Langer, 2017).
 
Practice Guidelines and Position Statements
No guidelines that discuss the role of stationary ultrasonic diathermy devices in individuals with musculoskeletal pain were identified.
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below.
 
Summary of Key Trials
 
Ongoing
  • NCT05050448 Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis has a planned enrollment of 60, and an anticipated completion date of September 2022
  • NCT05254574 Sustained Acoustic Medicine for Knee Osteoarthritis Pain has a planned enrollment of 90, and an anticipated completion date of January 2023
Unpublished
  • NCT04177537 Efficacy of SAM Sport as an Addon to Traditional Therapy in Treating Sports-related Injuries has a planned enrollment of 15, and an anticipated completion date of October 2015
  • NCT05254470 Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care has a planned enrollment of 135, and an anticipated completion date of February 2022
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
K1004Low frequency ultrasonic diathermy treatment device for home use
K1036Supplies and accessories (e.g., transducer) for low frequency ultrasonic diathermy treatment device, per month
References: Draper DO, Klyve D, Ortiz R, et al.(2018) Effect of low-intensity long-duration ultrasound on the symptomatic relief of knee osteoarthritis: a randomized, placebo-controlled double-blind study. J Orthop Surg Res. Oct 16 2018; 13(1): 257. PMID30326947

Langer MD, Byrne HK, Henry T, et al.(2017) The effect of low intensity wear-able ultrasound on blood lactate and muscle performance after high intensity resistance exercise. J Exerc Physiol. 2017;20(4):132-146

Langer MD, Lewis GK.(2015) Sustained Acoustic Medicine: A Novel Long Duration Approach to Biomodulation Utilizing Low Intensity Therapeutic Ultrasound. Proc SPIE Int Soc Opt Eng. May 2015; 9467. PMID 30078928

Lewis GK, Langer MD, Henderson CR, et al.(2013) Design and evaluation of a wearable self-applied therapeutic ultrasound device for chronic myofascial pain. Ultrasound Med Biol. Aug 2013; 39(8): 1429-39. PMID 23743101

Matthews MJ, Stretanski MF.(2022) Ultrasound Therapy. In: StatPearls [Internet]. StatPearls Publishing; 2022.

Petterson S, Plancher K, Klyve D, et al.(2020) Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial. J Pain Res. 2020; 13: 1277-1287.PMID 32606899

Rigby JH, Taggart RM, Stratton KL, et al.(2015) Intramuscular Heating Characteristics of Multi hour Low-Intensity Therapeutic Ultrasound. J Athl Train. Nov 2015; 50(11): 1158-64. PMID 26509683

U. S. Food and Drug Administration (FDA).(2022) Ultrasonic Therapy Product or Ultrasonic Diathermy. Updated September 28, 2020.Accessed October 26, 2022.

U.S. Department of Health and Human Services (HHS).(2019) Pain management best practices. May 2019.https://www.hhs.gov/sites/default/files/pain-mgmt-best-practices-draft-final-report-05062019.pdf. Accessed October 26,2022.

Uddin SMZ, Komatsu DE, Motyka T, et al.(2021) Low-Intensity Continuous Ultrasound Therapies—A Systematic Review of Current State-of-the-Art and Future Perspectives. J Clin Med. Jun 18 2021; 10(12). PMID 34207333

Winkler SL, Urbisci AE, Best TM.(2021) Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematicreview and meta-analysis. BMC Sports Sci Med Rehabil. Dec 18 2021; 13(1): 159. PMID 34922606
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.