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NCT04683042 · ClinicalTrials.gov registry record · Phase 3
Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
A Phase 3 study of Fibromyalgia, sponsored by Kathleen Sluka.
- Completed
- Registry status
- Phase 3
- Development phase
- 459
- Enrollment target
- 6
- Study locations
NCT04683042: Completed Phase 3 study of Fibromyalgia, sponsored by Kathleen Sluka.
NCT04683042 is a Phase 3 study of Fibromyalgia that has completed, run by Kathleen Sluka. The registered enrollment target is 459 participants, above the 173-participant average among 76 other Fibromyalgia trials with a reported enrollment target (165% higher). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04683042, a Phase 3 study of Fibromyalgia, has completed, sponsored by Kathleen Sluka.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 459 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Numeric rating scale of 0-10 for reduction of movement-evoked pain measured by 11-point NRS from baseline to 60 days.
Conditions Studied
Interventions
- DEVICE Transcutaneous Electrical Nerve Stimulation (TENS) with PT
- OTHER PT only
Study Locations (6)
Illinois
- University of Illinois at Chicago - Chicago
- Rock Valley Physical Therapy - Moline
Iowa
- Kepros Physical Therapy and Performance - Cedar Rapids
- Genesis Physical Therapy - Davenport
South Dakota
- Big Stone Therapies (BST) - Big Stone City
Wisconsin
- Advanced Physical Therapy Sport Medicine - Appleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 459 participants |
| Start Date | 2021-01-22 |
| Est. Completion | 2025-03-11 |
| Phase | Phase 3 |
What the finished NCT04683042 record still lists
NCT04683042 is an interventional study that assigns participants to a tested intervention. The registered 459 participants enrollment target is mid-sized for trials with a published cap, above the 173-participant average among 76 other Fibromyalgia trials with a reported enrollment target (165% higher).
The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 2 interventions - of which Transcutaneous Electrical Nerve Stimulation (TENS) with PT is the first listed.
NCT04683042 lists 6 locations in 4 states (Illinois, Iowa, South Dakota).
Frequently Asked Questions
What is clinical trial NCT04683042 about?
NCT04683042 is a clinical study titled "Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial". 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 disea...
What is the current status of trial NCT04683042?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 459 participants. The study started on 2021-01-22. Estimated completion is 2025-03-11.
What conditions does trial NCT04683042 study?
This clinical trial studies the following conditions: Fibromyalgia.
What interventions are being tested in trial NCT04683042?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (TENS) with PT (DEVICE), PT only (OTHER).
Who is sponsoring clinical trial NCT04683042?
This trial is sponsored by Kathleen Sluka, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04683042 being conducted?
This trial has 6 study locations across Illinois, Iowa, South Dakota, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04683042's enrollment target sits among peer trials
459 6th of 76 higher than 71 of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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