NCT05112094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 8, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

October 3, 2021

Last Update Submit

October 27, 2021

Conditions

Reflex Sympathetic Dystrophy of Upper LimbStroke

Keywords

shoulder painmagnetic stimulationelectric stimulationreflex sympathetic dystrophy

Outcome Measures

Primary Outcomes (1)

  • pain

    change of 10-point Visual Analog Scale (0-10, higher scores mean a worse outcome)

    0,7, 14,28 days

Secondary Outcomes (3)

  • strength of upper limb

    0,7, 14,28 days

  • spasticity of upper limb

    0,7, 14,28 days

  • range of motion of shoulder

    0,7, 14,28 days

Study Arms (2)

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)

Device: peripheral magnetic stimulationOther: physical therapy

physical therapy only

PLACEBO COMPARATOR

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

Other: physical therapy

Interventions

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)

peripheral magnetic stimulation
physical therapyOTHER

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

peripheral magnetic stimulationphysical therapy only

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=20 years old
  • Stroke in recent 6 months
  • Clear consciousness
  • Clinical diagnosis of post-stroke shoulder-hand syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Reflex Sympathetic DystrophyStrokeShoulder Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Complex Regional Pain SyndromesAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Ming Yen Y Hsiao, MDPHD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Yen Hsiao

CONTACT

0972652857myferrant@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2021

First Posted

November 8, 2021

Study Start

August 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

November 8, 2021

Record last verified: 2021-07

Locations

TW(1)