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

National Taiwan University

Status: Unknown

Conditions: Stroke; Reflex Sympathetic Dystrophy of Upper Limb

Treatments: Other: physical therapy; Device: peripheral magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05112094

202105016RIPB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

peripheral magnetic stimulation

Experimental group

Description:

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)

Treatment:

Other: physical therapy

Device: peripheral magnetic stimulation

physical therapy only

Placebo Comparator group

Description:

regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)

Treatment:

Other: physical therapy