TENS Therapy for Fibromyalgia
(TENSXFibro Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Université de Sherbrooke

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the short-term (24-hour) effect of conventional transcutaneous electrical nerve stimulation (TENS) compared to Sham TENS on pain induced by resistance training in women with fibromyalgia. The main questions it aims to answer are: 1. Can conventional TENS effectively reduce pain intensity and unpleasantness during and after a resistance training session in women with fibromyalgia? 2. Is there a significant difference between the effects of conventional TENS and Sham TENS on exercise-induced pain in this population? Researchers will compare a conventional TENS group to a Sham TENS group to see if active TENS application during and after resistance training sessions leads to reduced pain levels and improved pain perception. Participants will: * Undergo a supervised resistance training session * Receive either conventional TENS or ShamTENS treatment during and after exercise * Complete pain assessments, measuring both intensity and unpleasantness, before, during, and up to 24 hours after exercise sessions

Research Team

Eligibility Criteria

This trial is for postmenopausal women with fibromyalgia who experience pain during exercise. Participants will be involved in a resistance training session and receive either real or sham TENS therapy to manage their pain.

Inclusion Criteria

I am 50 years old or older.

I can avoid caffeine, painkillers for 6 hours, and not smoke for 2 hours before the test.

I have gone through menopause.

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Exclusion Criteria

Have already participated in a research project involving TENS or used a TENS device in the past.

Have one or more contraindications to physical activity

Are physically active prior to the start of the study

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Treatment Details

Interventions

TENS Therapy (Electrotherapy)

Trial OverviewThe study tests if conventional TENS can reduce the intensity and unpleasantness of pain more effectively than Sham TENS during and after resistance training in postmenopausal women with fibromyalgia.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Conventional TENS with Resistance ExerciseExperimental Treatment1 Intervention

Conventional TENS will be administered using a 2-channel TENS unit (Biomed 2000XL) and carbon electrodes. Electrodes will be placed on the area identified by the participant as most painful (loco dolenti). The TENS parameters will be set to conventional stimulation (100 Hz, 60 ms), with the intensity adjusted to produce a strong paresthesia sensation without causing pain. TENS will be applied for 10 minutes before the first set and maintained throughout the exercise sets.

Group II: Sham TENS with Resistance ExercisePlacebo Group1 Intervention

The sham TENS procedure will mimic the conventional TENS procedure, but the modified TENS device will not deliver electrical stimulation. Participants will be blinded to the intervention they will receive and will be told they could receive 2 types of TENS.