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TENS device shows promise for fibromyalgia pain relief in major trial

NCT ID NCT04683042

Symptom relief Sponsor: Kathleen Sluka Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding a TENS device (which uses mild electrical pulses) to regular physical therapy helps reduce pain during movement in people with fibromyalgia. Over 450 adults with fibromyalgia took part. Researchers measured pain levels and other symptoms to see if the combination approach works better than physical therapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

459 people

The number who actually took part.

Started

Jan 2021

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 until 99. 2. Clinician diagnosis of FM 3. Referred for land-based PT 4. Referred for treatment for FM or chronic pain (pain lasting more than 3 months) 5. Able to provide informed consent. 6. Fluent in reading English 7. Willing to use TENS Exclusion Criteria: 1. Contraindications to TENS use including: 1. Pacemaker, defibrillator, implanted neurostimulator or implanted device 2. Epilepsy 3. Currently pregnant or plan to become pregnant in the next 6 months 4. Allergic reaction to patches with gel 5. Current treatment for cancer 2. Currently enrolled in another pain control study 3. Use of TENS within the last 30 days 4. Clinically unstable medical or psychiatric issues

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Conditions

The condition(s) this trial relates to.

Chronic Pain fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

Contacts and locations

Locations

  • Advanced Physical Therapy Sport Medicine

    Appleton, Wisconsin, 54913, United States

  • Big Stone Therapies (BST)

    Big Stone City, South Dakota, 57216, United States

  • Genesis Physical Therapy

    Davenport, Iowa, 52807, United States

  • Kepros Physical Therapy and Performance

    Cedar Rapids, Iowa, 52404, United States

  • Rock Valley Physical Therapy

    Moline, Illinois, 61265, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60607, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.