TENS Therapy to Reduce Exercise-Induced Pain in Women With Fibromyalgia (TENSXFibro)

The Effect of Transcutaneous Electrical Nerve Stimulation on Exercise-Induced Pain in Women Living With Fibromyalgia

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation (TENS); Device: SHAM Transcutaneous electrical nerve stimulation (TENS)

Detailed Description

Study Design

Randomization with minimization will be performed using MinimPy software to ensure group balance, considering the following factors:

• Pain intensity, assessed using a pain scale (0-10)
• Fibromyalgia severity, assessed using the Fibromyalgia Impact Questionnaire
• Age

Participants will be informed that different types of TENS stimulation may or may not produce a sensation, and this does not impact treatment effectiveness.

Resistance Exercise Protocol The resistance training protocol involves a leg press exercise performed at a 90° starting angle. Participants will undergo a familiarization period, a warm-up, and a repetitions-to-failure (RTF) test to determine their 5-repetition maximum (RM). The Epley equation will be used to predict the 1RM. Participants will then perform two sets of 10 repetitions at 60% of their estimated 1RM, with a 1-minute rest between sets. A kinesiologist will supervise the training session.

Data Collection

Baseline Assessments:

Demographic information (age, gender identity, height, weight, medication) Physical activity level (Physical Activity Questionnaire for Adults) Fibromyalgia severity (Fibromyalgia Impact Questionnaire) Kinesiophobia (Tampa Scale of Kinesiophobia) Treatment expectations (Numerical scale from -100 to 100) Blood pressure Repetitions to Failure Test (RTF)

Participants will also complete a digital logbook via REDCap to record their pain levels at the end of the day and 24 hours post-exercise.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 2J7
      • Centre de recherche sur le vieillissement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be 40 years of age or older.
• Have a diagnosis of fibromyalgia.
• Experience persistent pain in the lumbo-pelvic and lower limb region with an intensity ≥ 3/10 on a numerical scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable).
• Refrain from consuming caffeine and analgesics 6 hours before the experiment, and refrain from smoking cigarettes 2 hours before the experiment.

Exclusion Criteria:

• Are physically active prior to the start of the study, i.e., they meet the recommendations of 150 minutes per week of moderate to vigorous intensity activity or practice 2 times 30 minutes of muscle-strengthening exercises per week for 2 months.
• Suffer from poorly controlled cardiovascular diseases.
• Have one or more contraindications to physical activity
• Have one or more contraindications to TENS
• Have already participated in a research project involving TENS or used a TENS device in the past 10 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional TENS with Resistance Exercise; 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.	Device: Transcutaneous electrical nerve stimulation (TENS); Conventional TENS (100 Hz, 60 ms pulse width) will be applied for 10 minutes prior to and during resistance exercise (2 sets of 10 reps at 60% 1RM leg press). TENS' intensity will be adjusted to produce strong paresthesia without pain. Electrodes will be placed on participant-identified most painful area. Resistance exercise will consist of two sets of ten repetition with 1 min rest
Sham Comparator: Sham TENS with Resistance Exercise; 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.	Device: SHAM Transcutaneous electrical nerve stimulation (TENS); The participants will be able to see the same parameters as the conventional TENS (100 Hz, 60 ms pulse width) on the screen, but there will be no actual stimulation. Sham TENS will be applied for 10 minutes prior to and during resistance exercise (2 sets of 10 reps at 60% 1RM leg press). TENS' intensity will be adjusted to 4Hz for all participants in the Sham arm. Electrodes will be placed on participant-identified most painful area. Resistance exercise will consist of two sets of ten repetition with 1 min rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured using a Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst pain imaginable."	At baseline, immediately post-exercise, 15 minutes post-exercise, end of the day of the visit, and 24 hours post-exercise.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unpleasantness of pain	The unpleasantness of pain will be measured using a Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents "pain is not unpleasant" and 10 represents "pain is the most unpleasant imaginable."	At baseline, immediately post-exercise, 15 minutes post-exercise, end of the day of the visit, and 24 hours post-exercise.

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Actual): July 9, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; TENS; Women; Fibromyalgia; Sham; Conventional; Exercise-Induced Pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2025-5394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No