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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Reflex Sympathetic Dystrophy of Upper Limb
• Intervention / Treatment: Device: peripheral magnetic stimulation; Other: physical therapy

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Yen Hsiao; Phone Number: 0972652857; Email: myferrant@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Hsiao Ming Yen, MDPHD; Phone Number: 0972652857; Email: myferrant@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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)
Placebo Comparator: physical therapy only; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ming Yen Y Hsiao, MDPHD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: electric stimulation; shoulder pain; magnetic stimulation; reflex sympathetic dystrophy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Stroke; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: 202105016RIPB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No