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

NCT06834308 | Completed

• 1 other identifier: 2025-5394
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Conditions

Fibromyalgia

Keywords

Fibromyalgia; TENS; Exercise; Exercise-Induced Pain; Sham; Conventional; Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Unpleasantness of pain

  At baseline, immediately post-exercise, 15 minutes post-exercise, end of the day of the visit, and 24 hours post-exercise.

Study Arms (2)

Conventional TENS with Resistance Exercise

EXPERIMENTAL

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)

Sham TENS with Resistance Exercise

SHAM COMPARATOR

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)

Interventions

Transcutaneous electrical nerve stimulation (TENS) DEVICE

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

Conventional TENS with Resistance Exercise

SHAM Transcutaneous electrical nerve stimulation (TENS) DEVICE

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

Sham TENS with Resistance Exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 2J7, Canada

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding assessment: Participants' treatment expectations (before and after the first TENS application) will be used as an indicator of blinding success. The outcome assessor's blinding will be assessed by asking them to guess the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at Faculty of Medecine and Health Sciences of Université de Sherbrooke

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 19, 2025
• Study Start: February 18, 2025
• Primary Completion: July 9, 2025
• Study Completion: July 10, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

CA (1)