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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112094
• Other study ID #: 202105016RIPB
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 2022

Study information

• Verified date: July 2021
• Source: National Taiwan University Hospital
• Contact: Ming Yen Hsiao
• Phone: 0972652857
• Email: myferrant[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Stroke

Intervention

Device:
• peripheral magnetic stimulation
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)

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)	0,7, 14,28 days
Secondary	strength of upper limb	change of score of Manual muscle testing (0-5, higher scores mean a better outcome)	0,7, 14,28 days
Secondary	spasticity of upper limb	change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome)	0,7, 14,28 days
Secondary	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