Effects of Peripheral Repetitive Peripheral Magnetic Stimulation on Individuals With Elbow or Wrist Chronic Pain

NCT07544914 | Not Yet Recruiting

• 1 other identifier: Rithim Harmony - 5266
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tennis Elbow Syndrome; Golfer's Elbow; Carpal Tunnel Syndrome (CTS)

Keywords

rPMS; elbow; wrist; chronic pain; NIRS

Outcome Measures

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.

  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

  from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.

Study Arms (4)

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.

Device: Two days Active rPMS

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.

Device: Two days Sham rPMS

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.

Device: Two days Active rPMS

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.

Device: Two days Sham rPMS

Interventions

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.

Two days Active rPMS - Carpal Tunnel Syndrome; Two days active rPMS - Tennis/golfer syndrome

Two days Sham rPMS DEVICE

Sham coil gives very weak pulses off target that does not penetrate to the skin.

Two days Sham rPMS - Carpal Tunnel syndrome; Two days sham rPM - Tennis/golfer syndrome

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy.
• Inability to tolerate the stimulation or measurement procedures.
• Inability to adequately understand study instructions or provide informed consent.

Sponsors & Collaborators

• University of Manitoba: lead

MeSH Terms

Conditions

Elbow Tendinopathy; Carpal Tunnel Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zahra Moussavi

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari Garcia, M.Sc.

CONTACT

(204) 478-6352; MARITERE.GARCIACAMPUZANO@umanitoba.ca

Zahra Moussavi, Ph.D.

CONTACT

204-474-7023; Zahra.Moussavi@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04