BCBS/Regence Medical Policy Manual on CALMARE / Scrambler / TENS for Neuropathic Pain

                                                                               

Medical Policy Manual 
Topic: Transcutaneous Electrical Modulation Pain Reprocessing
Date of Origin: November 2011
Section: Medicine
Last Reviewed Date: November 2012
Policy No: 143
Effective Date: January 1, 2013

IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION
Transcutaneous electrical modulation pain reprocessing (TEMPR), also called scrambler therapy, is intended to interrupt transmission of pain signals by delivering electrical stimulation that is interpreted by the nervous system as “no pain”. Scrambler therapy is performed using a type of transcutaneous electrical stimulation (TENS) device that is specifically designed for this therapy. Cutaneous nerves are stimulated using 5 surface electrode pairs (i.e., channels) that are placed in the dermatomes above and below the pain area.
Unlike conventional TENS, scrambler therapy is administered in the office setting under physician supervision. According to Competitive Technologies, Inc., the makers of Calmare® Pain Therapy device, “the physician provides the initial consultation to discern the most effective path for electrode placement. Treatment applications are interactive between the patient and the provider, with the provider attending and making adjustments approximately every 10 minutes throughout the treatment session, which typically lasts an hour.”

Regulatory Status
The Calmare® Pain Therapy device (Competitive Technologies, Inc.) has 510k approval (K081258) from the U.S. Food and Drug Administration (FDA) under the name Scrambler Therapy MC-5A TENS


MEDICAL POLICY CRITERIA
Transcutaneous electrical modulation pain reprocessing (e.g., scrambler therapy) is considered investigational for the treatment of acute or chronic pain, including but not limited to the following:
A.
Arthritis (any type)
B.
Back and neck pain, chronic or acute
C.
Cancer pain
D.
Chemotherapy-related pain
E.
Musculoskeletal pain
F.
Neuropathic pain
G.
Pain syndromes [e.g., complex regional pain syndrome (CRPS); reflex sympathetic dystrophy (RSD)]
H.
Post-operative pain
I.
Traumatic injury
J.
Visceral pain

SCIENTIFIC EVIDENCE

Background
The most clinically relevant outcomes of therapy for intractable pain are improvements in pain and/or function. Both of these outcomes can be influenced by nonspecific effects, placebo response, natural history of the disease, and regression to the mean; therefore, these therapies need to be evaluated in randomized, controlled trials that maintain satisfactory blinding of the treatment assignment. The appropriate control for electrical stimulation devices for treatment of pain is sham treatment. Pain outcomes require quantifiable pre- and post-treatment measures, which are most commonly measured with a visual analogue scale (VAS). Collectively, the pain measurement literature cautions against using only statistical significance of difference in mean change in scores to determine clinical significance. More meaningful to patients and clinicians is the correlation of improvement in pain scores with improvement in function and quality of life. Thus, quantifiable pre- and post-treatment measures of functional status are also necessary.


Literature Review

Randomized controlled trials (RCTs)
There are no randomized trials that compare active with sham scrambler therapy. The only published RCT is a small, short-term pilot study that compared scrambler therapy with pain medication in 55 patients matched for type of pain which included postoperative neuropathic pain, postherpetic neuralgia, or spinal canal stenosis.[1,2] The authors reported significantly greater pain reduction in the scrambler therapy group compared with the medication control group at 1-, 2-, and 3-month follow-up. While this RCT is useful in informing hypothesis formation, it does not permit conclusions on efficacy and safety due to small size, lack of a sham control group, and short-term followup period.

Nonrandomized trials
The remaining published trials are limited to nonrandomized trials.[3-6] Evidence from these studies is unreliable due to methodological limitations, such as non-random allocation of treatment, non-blinded study design, and lack of comparison groups.

Clinical Practice Guidelines
There are no clinical practice guidelines from professional associations that recommend scrambler therapy.

Summary
The evidence is not sufficient to permit conclusions about the benefits of transcutaneous electrical modulation pain reprocessing (scrambler therapy) as a treatment for pain from any etiology; therefore this therapy is considered investigational.

REFERENCES
1. Marineo, G, Iorno, V, Gandini, C, Moschini, V, Smith, TJ. Scrambler Therapy May Relieve Chronic Neuropathic Pain More Effectively Than Guideline-Based Drug Management: Results of a Pilot, Randomized, Controlled Trial. J Pain Symptom Manage. 2011 Jul 13. PMID: 21763099
2. Marineo, G, Iorno, V, Gandini, C, Moschini, V, Smith, TJ. Scrambler therapy may relieve chronic neuropathic pain more effectively than guideline-based drug management: results of a pilot, randomized, controlled trial. J Pain Symptom Manage. 2012 Jan;43(1):87-95. PMID: 21763099
3. Sabato, AF, Marineo, G, Gatti, A. Scrambler therapy. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):479-82. PMID: 16012423
4. Marineo, G. Untreatable pain resulting from abdominal cancer: new hope from biophysics? JOP. 2003 Jan;4(1):1-10. PMID: 12555009
5. Smith, TJ, Coyne, PJ, Parker, GL, Dodson, P, Ramakrishnan, V. Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare(R)) for chemotherapy-induced peripheral neuropathy. J Pain Symptom Manage. 2010 Dec;40(6):883-91. PMID: 20813492
6. Ricci, M, Pirotti, S, Scarpi, E, et al. Managing chronic pain: results from an open-label study using MC5-A Calmare(R) device. Support Care Cancer. 2012 Feb;20(2):405-12. PMID: 21394458

CROSS REFERENCES
Functional Neuromuscular Electrical Stimulation, Regence Medical Policy Manual, Durable Medical Equipment, Policy No. 83.04
Interferential Stimulation for the Treatment of Pain, Regence Medical Policy Manual, Durable Medical Equipment, Policy No. 83.07
Sympathetic Electrical Stimulation Therapy, Regence Medical Policy Manual, DME, Policy No. 83.08
Pulsed Electrical Stimulation for the Treatment of Arthritis, Regence Medical Policy Manual, DME, Policy No. 83.10
Percutaneous Neuromodulation Therapy (PNT), Regence Medical Policy Manual, Surgery, Policy No. 44



© 2013 L. Ryan