Journal article
The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study (FM-TIPS) Protocol: A Multisite Embedded Pragmatic Trial
Physical therapy : journal of the American Physical Therapy Association, Vol.102(11), pzac116
08/29/2022
DOI: 10.1093/ptj/pzac116
PMCID: PMC10071449
PMID: 36036838
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.
Details
- Title: Subtitle
- The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study (FM-TIPS) Protocol: A Multisite Embedded Pragmatic Trial
- Creators
- Andrew A Post - Roy J. and Lucille A. Carver College of MedicineDana L Dailey - Saint Ambrose UniversityEmine O Bayman - University of IowaRuth L Chimenti - Roy J. and Lucille A. Carver College of MedicineMichele Costigan - The University of Iowa Clinical Trials Statistical and Data Management Center , Iowa City IA , USACarla Franck - University of IowaTrevis Huff - University of IowaElizabeth Johnson - Vanderbilt University Medical CenterMaxine Koepp - University of IowaDavid-Erick Lafontant - University of IowaMegan E McCabe - University of IowaTina Neill-Hudson - University of IowaCarol G T Vance - Roy J. and Lucille A. Carver College of MedicineBarb Van Gorp - Roy J. and Lucille A. Carver College of MedicineBridget M Zimmerman - University of IowaDixie Ecklund - University of IowaLeslie J Crofford - Vanderbilt University Medical CenterKathleen A Sluka - Roy J. and Lucille A. Carver College of Medicine
- Resource Type
- Journal article
- Publication Details
- Physical therapy : journal of the American Physical Therapy Association, Vol.102(11), pzac116
- DOI
- 10.1093/ptj/pzac116
- PMID
- 36036838
- PMCID
- PMC10071449
- NLM abbreviation
- Phys Ther
- ISSN
- 0031-9023
- eISSN
- 1538-6724
- Grant note
- DOI: 10.13039/100000002, name: National Institutes of Health, award: UG3AR076387; DOI: 10.13039/100000069, name: National Institute of Arthritis and Musculoskeletal and Skin Diseases; name: Management of Pain to Reduce Opioid Prescribing Resource Coordinating Center, award: U24AT010961
- Language
- English
- Date published
- 08/29/2022
- Academic Unit
- Iowa Neuroscience Institute; Biostatistics; Nursing; Anesthesia; Physical Therapy and Rehabilitation Science; Neuroscience and Pharmacology
- Record Identifier
- 9984296995802771
Metrics
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