Reflex Sympathetic Dystrophy of Upper LimbNCT05112094
Peripheral Magnetic Stimulation to Treat Patient With Post-stroke Shoulder-hand Syndrome
A study testing peripheral magnetic stimulation and physical therapy in people with Reflex Sympathetic Dystrophy of Upper Limb and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Reflex Sympathetic Dystrophy of Upper Limb, Stroke
- What is being tested?
- peripheral magnetic stimulation and physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2021to 20 Nov 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=20 years old
- Stroke in recent 6 months
- Clear consciousness
- Clinical diagnosis of post-stroke shoulder-hand syndrome
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Reflex Sympathetic Dystrophy of Upper Limb, Stroke
- Being tested
- peripheral magnetic stimulation, physical therapy
- Keywords
- shoulder pain, magnetic stimulation, electric stimulation, reflex sympathetic dystrophy
- Medical subject headings
- Reflex Sympathetic Dystrophy, Stroke, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral magnetic stimulationDevice
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)
physical therapyOther
regular physical therapy(shoulder range of motion exercise and stretching 30-40 minutes per day)
| Study group | Role | What they receive |
|---|---|---|
| peripheral magnetic stimulation | Experimental | 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) Receives: Device: peripheral magnetic stimulation; Other: physical therapy |
| physical therapy only | Placebo comparator | regular physical therapy (shoulder range of motion exercise and stretching 30-40 minutes per day) Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)
Measured: 0,7, 14,28 days
Secondary outcomes (3)
strength of upper limb
change of score of Manual muscle testing (0-5, higher scores mean a better outcome)
Measured: 0,7, 14,28 days
spasticity of upper limb
change of Modified Ashworth Scale (0-4, higher scores mean a worse outcome)
Measured: 0,7, 14,28 days
range of motion of shoulder
Change in range of motion in degree in flexion, abduction, external and internal rotation (0-180 degrees,higher scores mean a better outcome)
Measured: 0,7, 14,28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Jul 2021
- Primary completion29 Jun 2022
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflex Sympathetic Dystrophy of Upper LimbStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Yen Y Hsiao, MDPHD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112094
- Sponsor's protocol ID
- 202105016RIPB
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No