The Effect of Transcutaneous Electrical Nerve Stimulation on Exercise-Induced Pain in Women Living With Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Université de Sherbrooke
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Pain intensity
Study Overview
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:
- Can conventional TENS effectively reduce pain intensity and unpleasantness during and after a resistance training session in women with fibromyalgia?
- 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Transcutaneous electrical nerve stimulation (TENS) (Device)
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.
Intervention: SHAM Transcutaneous electrical nerve stimulation (TENS) (Device)
Outcomes
Primary Outcomes
Pain intensity
Time Frame: At baseline, immediately post-exercise, 15 minutes post-exercise, end of the day of the visit, and 24 hours post-exercise.
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."
Secondary Outcomes
- Unpleasantness of pain(At baseline, immediately post-exercise, 15 minutes post-exercise, end of the day of the visit, and 24 hours post-exercise.)
Investigators
Guillaume Léonard
Professor at Faculty of Medecine and Health Sciences of Université de Sherbrooke
Université de Sherbrooke