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

Completed · Phase 3

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT04683042

Run by

Kathleen Sluka

People needed

459

Starts

2021-01-22

Expected to finish

2025-03-11

Last updated by the study team

2025-10-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 until 99.
• Clinician diagnosis of FM
• Referred for land-based PT
• Referred for treatment for FM or chronic pain (pain lasting more than 3 months)
• Able to provide informed consent.
• Fluent in reading English
• Willing to use TENS

You may not qualify if…

• Contraindications to TENS use including:
• Pacemaker, defibrillator, implanted neurostimulator or implanted device
• Epilepsy
• Currently pregnant or plan to become pregnant in the next 6 months
• Allergic reaction to patches with gel
• Current treatment for cancer
• Currently enrolled in another pain control study
• Use of TENS within the last 30 days
• Clinically unstable medical or psychiatric issues

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States
• Rock Valley Physical Therapy — Moline, Illinois, United States
• Kepros Physical Therapy and Performance — Cedar Rapids, Iowa, United States
• Genesis Physical Therapy — Davenport, Iowa, United States
• Big Stone Therapies (BST) — Big Stone City, South Dakota, United States
• Advanced Physical Therapy Sport Medicine — Appleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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