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

Not Applicable

• Conditions: Reflex Sympathetic Dystrophy of Upper Limb; Stroke
• Interventions: Device: peripheral magnetic stimulation; Other: physical therapy

• Registration Number: NCT05112094
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-08-01
• Study First Submitted: 2021-10-03
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
peripheral magnetic stimulation	physical therapy	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)
peripheral magnetic stimulation	peripheral magnetic stimulation	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)
physical therapy only	physical therapy	regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)

Primary Outcome Measures

Name	Time	Method
pain	0,7, 14,28 days	change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan