Status:
COMPLETED
Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
Lead Sponsor:
Kathleen Sluka
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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)...
Detailed Description
This study is a pragmatic clinical trial in outpatient PT practices utilizing cluster randomization by healthcare system and facility size. Sites will be randomized to enroll all eligible and consente...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT04683042
Start Date
January 22 2021
End Date
March 11 2025
Last Update
October 29 2025
Active Locations (6)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
2
Rock Valley Physical Therapy
Moline, Illinois, United States, 61265
3
Kepros Physical Therapy and Performance
Cedar Rapids, Iowa, United States, 52404
4
Genesis Physical Therapy
Davenport, Iowa, United States, 52807