Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study (FM TIPS): an embedded pragmatic clinical trial in physical therapy clinics

Abstract

Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain with significant movement-evoked pain. Transcutaneous electrical nerve stimulation (TENS), a non-pharmacological treatment, is efficacious for reduction of pain and fatigue in FM. While physical therapists are trained in the use of TENS, it is an underutilized tool in physical therapy (PT) clinics. To this end, we designed a pragmatic clinical trial to test if using TENS in a PT setting is feasible and if FM patients using TENS show reduced movement-evoked pain, improved adherence to PT, are more likely to reach their therapeutic goals. During a 1-year planning period the study team designed and set up procedures to implement the trial into 24 physical therapy clinics within 5 healthcare systems. Surveys and interviews with PT sites and interactions with the NIH Collaboratory group guided design of this pragmatic trial. The 24 PT clinics will be cluster-randomized and stratified by healthcare system into two groups: (1) No TENS (PT usual care) or (2) TENS+ (TENS plus PT usual care) with a goal of enrolling 600 participants the trial. Assessments will be collected at baseline then at 30-, 60-, 90- and 180-days from randomization through electronic data capture from participants directly and from the electronic health record. The primary outcome is a reduction in movement-evoked pain during a sit and stand test (baseline to 60 days) with secondary outcomes across multiple domains including pain, fatigue, sleep, disease impact, medication usage, psychosocial variables, patient-specific functional goals, and adherence to PT. Successful completion of this trial will provide generalizable effectiveness data on TENS for referring providers, physical therapists, patients, and insurers and will inform future pragmatic trials of non-pharmacological treatments conducted in PT practices. NIH; 4UH3AR076387-02 REVISED.