Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome

Study Overview
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Brief Summary
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Shoulder-hand syndrome is a common complication following stroke, constituting of excessive pain, swelling, heat, limited range of motion, and trophic change of the affected limbs. It not only has an extensive negative impact on both physical and psychological aspects of a stroke patient's well-being, but also impose burden on the health care system and the patient's family. Despite its relatively high incidence, there is neither well-established treatment protocol, nor high quality evidence for a single effective treatment. The objective of the present study is to investigate the efficacy, including pain, spasticity, and subluxation reduction, muscle strengthening, and shoulder range of motion improvement, of high-intensity peripheral magnetic stimulation generated by the super-inductive system to treat patients with post-stroke shoulder-hand syndrome.

Detailed Description
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The present study aims to investigate the therapeutic effects achieved by the peripheral magnetic stimulation for treating post-stroke shoulder-hand syndrome. The investigators plan to use high-intensity peripheral magnetic stimulation generated by the super-inductive system for treatment of post-stroke shoulder-hand syndrome. In terms of study design, the treatment group will receive 10 sessions of high-intensity peripheral magnetic stimulation 5 days a week for 2 weeks, with physical and occupational therapy kept as usual; while the control group will only receive conventional physical and occupational therapy. Comprehensive assessment, including history taking and physical examination testing for muscle strength, spasticity, shoulder range of motion, before and after the intervention will be conducted for evaluation.

Official Title
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Therapeutic Effect of Peripheral Magnetic Stimulation Generated by the Super-inductive System to Treat Patient With Post-stroke Shoulder-hand Syndrome

Conditions
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Reflex Sympathetic Dystrophy of Upper Limb, Stroke

Intervention / Treatment
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* Device: peripheral magnetic stimulation
* Other: physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: >=20 years old Stroke in recent 6 months Clear consciousness Clinical diagnosis of post-stroke shoulder-hand syndrome Exclusion criteria: Acute bursitis, tendonitis or tendon tear Fracture, dislocation or joint infection within 3 months Malignancy at treatment site Seizure Prosthesis or implant at treatment site Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peripheral magnetic stimulation<br>peripheral magnetic stimulation (50-80% output, 20-40Hz, pulse duration 3-5 seconds, for 15 minutes) + physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day) | Device: peripheral magnetic stimulation<br>* peripheral magnetic stimulation at ipsilateral shoulder ((50-80% output, 20-40Hz, pulse duration 3-5 seconds, for 15 minutes) ) + regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)<br>Other: physical therapy<br>* regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)<br>|
| Placebo Comparator: physical therapy only<br>regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day) | Other: physical therapy<br>* regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome) | 0,7, 14,28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| strength of upper limb | change of score of Manual muscle testing (0-5, higher scores mean a better outcome) | 0,7, 14,28 days | 
| spasticity of upper limb | change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome) | 0,7, 14,28 days | 
| range of motion of shoulder | Change in range of motion in degree in flexion, extension, abduction, external and internal rotation (0-180 degrees,higher scores mean a better outcome) | 0,7, 14,28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder pain, magnetic stimulation, electric stimulation, reflex sympathetic dystrophy