UH3 Project: Fibromyalgia TENS in Physical Therapy Study (FM-TIPS)
Overview
Principal Investigators:
Sponsoring Institution: University of Iowa
Collaborators:
- Advanced Physical Therapy and Sports Medicine
- Big Stone Physical Therapy
- Genesis Healthcare Systems
- Kepros Physical Therapy and Performance
- Rock Valley Physical Therapy
- University of Illinois Chicago
NIH Institute Providing Oversight: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Program Official: Charles Washabaugh, PhD (NIAMS)
Project Scientist: Joe Bonner, PhD (National Institute of Child Health and Human Development [NICHD]/National Center for Medical Rehabilitation Research [NCMRR])
ClinicalTrials.gov Identifier: NCT04683042
Trial Status: Enrolling
Trial Summary
Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness, and stiffness associated with fatigue and sleep disturbance. The goal of reducing opioid use in patients with chronic pain requires that proven non-pharmacological treatments are applied in clinical practice. We have recently completed the FAST (Fibromyalgia Activity Study with TENS) trial demonstrating efficacy of Active TENS compared with Placebo TENS or No Treatment in women with FM. FAST was the first study to conclusively demonstrate efficacy of TENS in musculoskeletal pain.
While physical therapists are trained in the use of TENS, it is underused in clinical practice. This application proposes to conduct an embedded pragmatic trial to compare effectiveness of physical therapy with or without the addition of TENS for FM patients within physical therapy (PT) practices as the study sites. The overall goal of this proposal is to (1) demonstrate the feasibility of adding TENS to treatment of patients with FM in a real-world PT practice setting, and (2) to determine if the addition of TENS to PT reduces pain, increases adherence to PT, and allows patients with FM to reach their specific functional goals with less medication use.
- UG3
- Aim 1: Recruit physical therapy practices as research sites for this embedded pragmatic clinical trial and understand usual practice for patients with FM to inform trial processes.
- Aim 2: Ensure adequacy of infrastructure at potential study sites to complete a PT-embedded pragmatic trial.
- UH3
- Aim 1: Assess the feasibility of using TENS in addition to physical therapy for treatment of patients with FM using a cluster-randomized pragmatic clinical trial of routine PT (as selected by the therapist on an individual basis) with or without TENS.
- Aim 2: Determine if TENS use improves the symptoms of FM, increases adherence to physical therapy, increases the likelihood of meeting therapeutic goals, and reduces medication use.
This study will address the critical need to develop a strategy for implementing effective nonpharmacologic treatments for FM. Our multidisciplinary research team will leverage their experience from a recently completed randomized controlled trial and an implementation study for TENS in primary care practice to complete a real-world trial of TENS for FM in a PT setting. Successful completion of this trial will provide generalizable effectiveness data for referring providers, physical therapists, and insurers and will inform future pragmatic trials of nonpharmacologic treatments conducted in PT practices.
Data and Resource Sharing
- FM TIPS-2021-UH3 Follow-up
FM TIPS-Ethics and Regulatory UH3 Follow-up
- FM TIPS-UG3 Minutes and Supplement_C
FM TIPS Ethics and Regulatory Discussion
Featured Interviews
Co–principal investigators Dr. Kathleen Sluka and Dr. Leslie Crofford discuss the FM TIPS NIH Collaboratory Trial.
News and Interviews
- News_Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
January 8, 2024: Pragmatic Trials Researchers Share Lessons From Collecting Patient-Reported Outcomes in the Electronic Health Record
- News_Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
December 13, 2022: In Our Tenth Year, a Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
- Video_Update on the FM-TIPS Demonstration Project
Video Interview: Update on the FM-TIPS NIH Collaboratory Trial
- News_FM-TIPS Seeks More Treatment Options for Patients With Fibromyalgia
May 24, 2022: FM-TIPS Seeks More Treatment Options for Patients With Fibromyalgia
- News_FM TIPS begins enrollment
March 18, 2021: FM-TIPS Becomes First PRISM Trial to Begin Enrollment
- News_Study Snapshots for PRISM Projects
January 11, 2021: Study Snapshots for Four PRISM UH3 Trials Are Available
- News_PRISM_Continuation
October 6, 2020: Four PRISM Trials Awarded Continuation from Planning to Implementation Phase
- News_FM TIPS Explores Novel Fibromyalgia Treatment in Physical Therapy Practices
March 4, 2020: FM TIPS Explores Novel Fibromyalgia Treatment in Physical Therapy Practices: An Interview With Dr. Kathleen Sluka and Dr. Leslie Crofford
- An Interview With Dr. Kathleen Sluka and Dr. Leslie Crofford
Video Interview: Interview With Dr. Kathleen Sluka and Dr. Leslie Crofford
Publications
- Vance et al Medicina (Kaunas) 2022
Using TENS for pain control: update on the state of the evidence
- Post et al Phys Ther 2022
FM-TIPS Study Design Paper
- Shraim et al Pain 2022
Features and methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a Delphi expert consensus study
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Raja et al Pain 2020
The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises
- FM-TIPS Study Snapshot
FM-TIPS Study Snapshot
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_How Are PRO Measures Used
Living Textbook: How are PRO Measures Used?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
Presentations
- 2023 AAHPM Upstreaming PC_ ED Opportunities Tan 23Mar2023.pptx
Upstreaming Palliative Care: Emergency Department Opportunities
- SC-Mtg-2023-Day2-Sluka
Kathleen Sluka FM-TIPS Presentation 2023 Steering Committee Meeting
- SC-Mtg-2022-Day-2-Sluka
FM-TIPS Presentation at 2022 Steering Committee Meeting
- GR-Video-07-24-20
TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (GR Video 2020)
- GR-Slides-07-24-20
TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (GR Slides 2020)
- FM TIPS_Sluka_Crofford_PRISM Kickoff_FINAL1
FM-TIPS Presentation at PRISM Kickoff Meeting