Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
2 other identifiers
interventional
459
1 country
6
Brief Summary
The purpose of this study is to determine if addition of Transcutaneous Electrical Nerve Stimulation (TENS) to routine physical therapy improves movement-evoked pain in patients with fibromyalgia (FM). The study will also determine if addition of TENS to routine physical therapy (PT) improves disease activity and symptoms, increases adherence to physical therapy, increases the likelihood of meeting patient specific functional goals, and reduces medication use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2021
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedStudy Start
First participant enrolled
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2025
CompletedOctober 29, 2025
October 1, 2025
4.1 years
December 22, 2020
October 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of movement-evoked pain (0-10 Low to High scale) during the Sit and Stand Test
Numeric rating scale of 0-10 for reduction of movement-evoked pain measured by 11-point NRS from baseline to 60 days.
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Secondary Outcomes (8)
Change in the resting pain score (0 - 10 Low to High scale)
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Pain interference (BPI) (0-10 Low to High Scale)
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
FM Disease activity (FIQR) (0-10 Low to High Scale)
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Resting fatigue (NRS) (0-10 Low to High Scale)
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
Movement-evoked fatigue (NRS) (0-10 Low to High Scale)
Research Homework before PT Visit 3 (Day 1), Day 60 +/- 5 days Home
- +3 more secondary outcomes
Study Arms (2)
TENS with PT
ACTIVE COMPARATORTENS with PT group: The TENS with PT group will receive usual PT care and following enrollment, during the second PT visit, participants will receive TENS units and instruction on use of the TENS units. TENS will be applied to the upper and lower back with butterfly electrodes using the following parameters: mixed frequency (2-125Hz), strong but comfortable intensity, variable pulse duration from 100-250 microseconds. TENS to be applied when the patient is active and doing exercises at home and during PT sessions for 30 minutes at least 2 hours per day. The TENS with PT group will complete TENS use to the end of the study at 6 months.
No TENS with PT
OTHERThe No TENS group will receive usual PT care until the primary endpoint timeframe of 60 days. After completion of the research homework at 60 days, TENS units will be mailed to the participants and a study team member will complete virtual TENS instruction. The no TENS group will complete TENS to the end of the study at 6 months.
Interventions
Use of TENS units along with routine PT therapy
Eligibility Criteria
You may qualify if:
- Age 18 until 99.
- Clinician diagnosis of FM
- Referred for land-based PT
- Referred for treatment for FM or chronic pain (pain lasting more than 3 months)
- Able to provide informed consent.
- Fluent in reading English
- Willing to use TENS
You may not qualify if:
- Contraindications to TENS use including:
- Pacemaker, defibrillator, implanted neurostimulator or implanted device
- Epilepsy
- Currently pregnant or plan to become pregnant in the next 6 months
- Allergic reaction to patches with gel
- Current treatment for cancer
- Currently enrolled in another pain control study
- Use of TENS within the last 30 days
- Clinically unstable medical or psychiatric issues
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kathleen Slukalead
Study Sites (6)
University of Illinois at Chicago
Chicago, Illinois, 60607, United States
Rock Valley Physical Therapy
Moline, Illinois, 61265, United States
Kepros Physical Therapy and Performance
Cedar Rapids, Iowa, 52404, United States
Genesis Physical Therapy
Davenport, Iowa, 52807, United States
Big Stone Therapies (BST)
Big Stone City, South Dakota, 57216, United States
Advanced Physical Therapy Sport Medicine
Appleton, Wisconsin, 54913, United States
Related Publications (1)
Post AA, Dailey DL, Bayman EO, Chimenti RL, Costigan M, Franck C, Huff T, Johnson E, Koepp M, Lafontant DE, McCabe ME, Neill-Hudson T, Vance CGT, Van Gorp B, Zimmerman BM, Ecklund D, Crofford LJ, Sluka KA. The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial. Phys Ther. 2022 Nov 6;102(11):pzac116. doi: 10.1093/ptj/pzac116.
PMID: 36036838DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Sluka, PhD, PT
University of Iowa
- PRINCIPAL INVESTIGATOR
Leslie Crofford, MD
Vanderbilt University
- STUDY DIRECTOR
Dana Dailey, PhD, PT
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Kathleen A. Sluka, PhD, PT, FAPTA
Study Record Dates
First Submitted
December 22, 2020
First Posted
December 24, 2020
Study Start
January 22, 2021
Primary Completion
March 11, 2025
Study Completion
March 11, 2025
Last Updated
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Analysis datasets will be made available at the time of publication of the primary manuscript. Complete datasets and accompanying resources will be deposited to the designated NIH Helping to End Addiction Long-term initiative (HEAL) data repository after the completion of the primary aim manuscript.
- Access Criteria
- In accordance with NIH Collaboratory policies, we will prepare the primary analysis datasets (at a minimum) for submission to the Collaboratory Coordinating Center. In accordance with International Committee of Medical Journal Editors (ICMJE) policies, we will prepare the primary analysis datasets for review and reproducibility by peer-reviewed journals. We will prepare the final datasets and accompanying resource documents for final deposit to the designated NIH HEAL data repository. Publications will be made available to the public using open access publishing, so they become available immediately to the public. All publications will be accessible through PubMED, google scholar, and available to the public through open access.
The current study is expected to generate patient-reported outcomes for individuals with fibromyalgia across a broad spectrum of domains, pain, fatigue, function, psychological factors, and quality of life. We will also collect some data from the electronic health record about number of physical therapy visits, Current Protocol Terminology (CPT) codes for treatments, and the patient-specific functional scale. In addition, we will have TENS usage data downloaded from the TENS devices that will show the number of minutes of TENS use and the number of 30 minute sessions completed. Data will be collected prior to the intervention (baseline data) and 30, 60, 90 and 180 days after enrollment.