Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome
Primary Purpose
Reflex Sympathetic Dystrophy of Upper Limb, Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
peripheral magnetic stimulation
physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Reflex Sympathetic Dystrophy of Upper Limb focused on measuring shoulder pain, magnetic stimulation, electric stimulation, reflex sympathetic dystrophy
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
peripheral magnetic stimulation
physical therapy only
Arm 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)
regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)
Outcomes
Primary Outcome Measures
pain
change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)
Secondary Outcome Measures
strength of upper limb
change of score of Manual muscle testing (0-5, higher scores mean a better outcome)
spasticity of upper limb
change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome)
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)
Full Information
NCT ID
NCT05112094
First Posted
October 3, 2021
Last Updated
October 27, 2021
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05112094
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflex Sympathetic Dystrophy of Upper Limb, Stroke
Keywords
shoulder pain, magnetic stimulation, electric stimulation, reflex sympathetic dystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
peripheral magnetic stimulation
Arm Type
Experimental
Arm 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)
Arm Title
physical therapy only
Arm Type
Placebo Comparator
Arm Description
regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day)
Intervention Type
Device
Intervention Name(s)
peripheral magnetic stimulation
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)
Primary Outcome Measure Information:
Title
pain
Description
change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)
Time Frame
0,7, 14,28 days
Secondary Outcome Measure Information:
Title
strength of upper limb
Description
change of score of Manual muscle testing (0-5, higher scores mean a better outcome)
Time Frame
0,7, 14,28 days
Title
spasticity of upper limb
Description
change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome)
Time Frame
0,7, 14,28 days
Title
range of motion of shoulder
Description
Change in range of motion in degree in flexion, extension, abduction, external and internal rotation (0-180 degrees,higher scores mean a better outcome)
Time Frame
0,7, 14,28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Yen Hsiao
Phone
0972652857
Email
myferrant@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Yen Y Hsiao, MDPHD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao Ming Yen, MDPHD
Phone
0972652857
Email
myferrant@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome
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