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Fibromyalgia TENS in Physical Therapy Study (TIPS): an Embedded Pragmatic Clinical Trial

NCT04683042 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2025-10-29

No results posted yet for this 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

  • Fibromyalgia

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS) with PT

Use of TENS units along with routine PT therapy

OTHER

PT only

Routine PT therapy only

Sponsors & Collaborators

  • Kathleen Sluka

    lead OTHER

Principal Investigators

  • Kathleen Sluka, PhD, PT · University of Iowa

  • Leslie Crofford, MD · Vanderbilt University

  • Dana Dailey, PhD, PT · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2025-03-11
Completion
2025-03-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04683042 on ClinicalTrials.gov