Effects of Peripheral Repetitive Peripheral Magnetic Stimulation on Individuals With Elbow or Wrist Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis or self-reported history consistent with either medial or lateral epicondylitis or carpal tunnel syndromes.
Presence of chronic pain in the target area (mentioned above) at the time of enrollment.
Ability to understand the study procedures and provide informed consent.
Disqualifiers
Contraindications to peripheral magnetic stimulation, including implanted electronic medical devices or metallic implants in locations deemed unsafe for stimulation.
Open wounds, active skin conditions, or other local conditions at the stimulation site.
Current neurological, musculoskeletal, or systemic medical conditions that, in the opinion of the investigators, would interfere with safe participation or interpretation of study outcomes.
Current upper-limb injury or condition other than tennis/golfer elbow or carpal tunnel syndromes that could confound pain or perfusion measurements.
Trial design
Design model
Parallel
Treatments tested in this trial
Two days Active rPMS
DeviceIt is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity.
Two days Sham rPMS
DeviceSham coil gives very weak pulses off target that does not penetrate to the skin.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Two days active rPMS - Tennis/golfer syndromeExperimental treatment 1 intervention
Group B: Two days sham rPM - Tennis/golfer syndromeSham comparator 1 intervention
Group C: Two days Active rPMS - Carpal Tunnel SyndromeExperimental treatment 1 intervention
Group D: Two days Sham rPMS - Carpal Tunnel syndromeSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain pressure threshold (PPT)
PPT is measured by a pressure altimeter and identifies the minimum pressure that the subject feels pain.
Time frame
from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.Secondary outcomes
1
Change in visual subjective pain scale
the visual subjective pain scale is a score using 0 to 10 on the pain level.
Time frame
from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov