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Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial
NCT04683042 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04683042
The ClinicalTrials.gov registry entry for NCT04683042 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 459 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kathleen Sluka, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04683042 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Illinois, Iowa, South Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04683042?
The interventions under investigation include: Transcutaneous Electrical Nerve Stimulation (TENS) with PT (DEVICE), PT only (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04683042?
This trial is sponsored by Kathleen Sluka, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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