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This pilot, randomized, sham-controlled, single-blind study will evaluate the effectiveness of repetitive peripheral magnetic stimulation (rPMS) in reducing pain in adults with tennis/golfer's elbow or carpal tunnel syndrome. Approximately 40 participants will be randomly assigned to active or sham stimulation delivered over two consecutive days. Outcomes, including pressure pain threshold, subjective pain ratings, and local tissue oxygenation (fNIRS), will be assessed at baseline, immediately post-intervention, and during follow-up up to 6 months to evaluate both clinical effects and underlying physiological mechanisms.
Objectives - The primary objective is to investigate the effect of active repetitive peripheral magnetic stimulation (rPMS) in reducing pain in individuals with either tennis/golfer elbow syndrome (either medial or lateral epicondylitis) or carpal tunnel syndrome in a pilot randomized placebo-controlled clinical trial. The secondary objective is to investigate the duration of the rPMS effects up to 6 months.
Study Population - The study population will consist of two groups of individuals: one group including 10 with tennis/golfer elbow syndrome and second group including 10 with carpal tunnel syndrome. Participants will be recruited from volunteers by advertising and/or doctors' referral.
Research Design and Study Procedure - This study design is a parallel-cohort exploratory single-blind, randomized, sham-controlled study investigating the effect of rPMS in pain reduction in individuals with either elbow or wrist chronic pain. Eligible participants in each group will be stratified by condition (elbow vs carpal tunnel) and randomized within each stratum to active or sham rPMS. The sham group participants will have the option to receive the active treatment after a month of receiving the sham treatment.
The rPMS protocol is two consecutive days of therapy. In each day, the participants will receive 400 pulses at 10 HZ in 1.5 sec trains with 10-second intertrain intervals. All participants will be assessed for their pain levels at baseline, immediately post-intervention, one week after the intervention and then every month up to 6 months follow-up sessions.
The assessments include subjective Visual Analogue Scale (VAS) score for pain on a scale of 0 to 10, the minimum pressure pain threshold (PPT) and near-infrared spectroscopy (NIRS) over the target area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two days active rPMS - Tennis/golfer syndrome | Experimental | Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive real rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
|
| Two days sham rPM - Tennis/golfer syndrome | Sham Comparator | Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
|
| Two days Active rPMS - Carpal Tunnel Syndrome | Experimental | Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive REAL rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
|
| Two days Sham rPMS - Carpal Tunnel syndrome | Sham Comparator | Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two days Active rPMS | Device | It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in pain pressure threshold (PPT) | PPT is measured by a pressure altimeter and identifies the minimum pressure that the subject feels pain. | from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual subjective pain scale | the visual subjective pain scale is a score using 0 to 10 on the pain level. | from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mari Garcia, M.Sc. | Contact | (204) 478-6352 | MARITERE.GARCIACAMPUZANO@umanitoba.ca | |
| Zahra Moussavi, Ph.D. | Contact | 204-474-7023 | Zahra.Moussavi@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Zahra Moussavi | University of Manitoba | Principal Investigator |
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This is a small pilot study. Once there is enough data with good quality, the investigators will consider data sharing.
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This study design is a parallel-cohort exploratory single-blind, randomized, sham-controlled study investigating the effect of rPMS in pain reduction in individuals with either elbow or wrist chronic pain.
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| Two days Sham rPMS | Device | Sham coil gives very weak pulses off target that does not penetrate to the skin. |
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| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D002349 | Carpal Tunnel Syndrome |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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