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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:
Participants will:
Study Design
Randomization with minimization will be performed using MinimPy software to ensure group balance, considering the following factors:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche sur le vieillissement | Sherbrooke | Quebec | J1H 2J7 | Canada |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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.
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| 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 |
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| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |