CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 459 enrolled
Drug / intervention
Transcutaneous Electrical Nerve Stimulation (TENS) with PT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04683042
NCT04683042Phase 3Completed

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

Kathleen Sluka·interventional·Posted Dec 24, 2020·Updated Oct 29, 2025

In Brief

A Phase 3 clinical trial evaluating Transcutaneous Electrical Nerve Stimulation (TENS) with PT and PT only for Fibromyalgia. Completed, enrolled 459 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 24, 2020
Enrollment StartJan 22, 2021
Primary CompletionMar 11, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.5 years ago

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) with PTdevice

Use of TENS units along with routine PT therapy

PT onlyother

Routine PT therapy only