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The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. | LitMetric

AI Article Synopsis

  • The study investigates whether adding transcutaneous electrical nerve stimulation (TENS) to standard physical therapy can help reduce movement-related pain in people with fibromyalgia.
  • It uses a randomized design across multiple clinics, enrolling 600 participants who will receive either TENS or standard treatment, assessing pain reductions over 60 days.
  • Results will provide valuable data for healthcare decision-makers regarding the effectiveness of TENS in treating fibromyalgia and will guide future research on similar non-drug therapies for chronic pain management.

Article Abstract

Objectives: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting.

Methods: Fibromyalgia TENS in Physical Therapy Study is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term Initiative. This trial will utilize a randomized cluster design that includes more than 110 physical therapists in 24 to 30 physical therapy clinics within 6 health care systems and 7 states. Clinics will be randomized to TENS or No-TENS, stratified by health care system and clinic size. The plan is to enroll 600 participants, with all participants completing physical therapy as prescribed by their physical therapist. Participants at TENS clinics will utilize TENS for a minimum of 2-hour per day while at the physical therapy clinic and at home when active. The primary outcome is reduction in movement-evoked pain from baseline to day 60 on an 11-point numeric rating scale when participants sit and stand 5 times (Sit and Stand Test). Secondary outcomes include resting pain and fatigue, pain interference, fibromyalgia disease activity, movement-evoked fatigue, multidimensional assessment of fatigue, rapid assessment of physical activity, patient global impression of change, and common data elements shared across studies supported through the Helping to End Addiction Long-Term Initiative.

Impact: The findings from this study will provide effectiveness data on TENS for individuals with fibromyalgia for health care policymakers, clinicians, and insurers. Data from this study will also inform future pragmatic trials for nonpharmacological interventions and chronic musculoskeletal pain conditions.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10071449PMC
http://dx.doi.org/10.1093/ptj/pzac116DOI Listing

Publication Analysis

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