Clinical trial NCT05112094: Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome
Official title: Therapeutic Effect of Peripheral Magnetic Stimulation Generated by the Super-inductive System to Treat Patient With Post-stroke Shoulder-hand Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reflex Sympathetic Dystrophy of Upper Limb
Stroke
Keywords: shoulder pain
magnetic stimulation
electric stimulation
reflex sympathetic dystrophy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain
timeFrame: 0,7, 14,28 days
Secondary outcomes:
measure: strength of upper limb
timeFrame: 0,7, 14,28 days
measure: spasticity of upper limb
timeFrame: 0,7, 14,28 days
measure: range of motion of shoulder
timeFrame: 0,7, 14,28 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ming Yen Y Hsiao, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: