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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 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.

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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.

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

FieldValue
Enrollment Target 459 participants
Start Date 2021-01-22
Est. Completion 2025-03-11
Phase Phase 3

Sponsor

Kathleen Sluka

2 total trials

What the Registry Record Tells You About NCT04683042

The ClinicalTrials.gov registry entry for NCT04683042 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 459 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 173-participant average among 76 other Fibromyalgia trials with a reported enrollment target (165% higher). The listed sponsor is Kathleen Sluka, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 4 distinct geographic areas - top geographies include 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.

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