TENS for chronic low back pain

2021/08/26

CMS issued the National Coverage Decision (NCD) for Medical Insurance on June 8, 2012, allowing coverage of Transcutaneous Electrical Nerve Stimulation (TENS) for the treatment of chronic low back pain (CLBP). The issuance of this decision (that is, June 8, 2015) was carried out within the scope of Evidence Development (CED) that meets the following criteria.

A. The beneficiary has participated in the approved clinical study and met all the following requirements. Research must use proven and reliable instruments to solve one or more of the following problems in a random, controlled design. When the effects of previous use of TENS are properly considered in the research protocol, this can include a random crossover design.
1). Can the use of TENS provide clinically significant pain relief for CLBP's medical insurance beneficiaries?
2). Does the use of TENS provide clinically meaningful functional improvements for Medicare beneficiaries with CLBP?
3). Will the use of TENS affect the use of other medical treatments or services used in CLBP medical management?
B. The design of these studies must enable the control group and control group patients to receive the same concurrent treatment and sham (placebo) TENS or active TENS intervention.
The results of other clinical studies may provide sufficient evidence to provide information on this topic for future non-communicable diseases. CMS will maintain a list of all approved studies and post the list on this website.

Currently, CMS has not approved clinical studies involving TENS in the treatment of CLBP.

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