Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
CompletedPhase 3NCT04683042
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
- Conditions
- Interventions
- Device: Transcutaneous Electrical Nerve Stimulation (TENS) with PT
- Other: PT only
- Sponsor
- Kathleen Sluka
- Organization
- University of Iowa
- Start date
- 2021-01-22
- Primary completion
- 2025-03-11
- Sex
- All
- Age range
- from 18 Years to 99 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age 18 until 99. 2. Clinician diagnosis of FM 3. Referred for land-based PT 4. Referred for treatment for FM or chronic pain (pain lasting more than 3 months) 5. Able to provide informed consent. 6. Fluent in reading English 7. Willing to use TENS Exclusion Criteria: 1. Contraindications to TENS use including: 1. Pacemaker, defibrillator, implanted neurostimulator or implanted device 2. Epilepsy 3. Currently pregnant or plan to become pregnant in the next 6 months 4. Allergic reaction to patches with gel 5. Current treatment for cancer 2. Currently enrolled in another pain control study 3. Use of TENS within the last 30 days 4. Clinically unstable medical or psychiatric issues
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04683042