Acupuncture for Post-stroke Shoulder-hand Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborator:
Longhua Hospital
Information provided by (Responsible Party):
Zouqin Huang, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT02011854
First received: December 10, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

Shoulder-hand syndrome,a common complication of stroke patient,which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community hospital.


Condition Intervention Phase
Shoulder-hand Syndrome
Device: rehabilitation
Device: Acupuncture
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture and Traditional Chinese Medicine Combined With Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome in Community Hospital: a Multicenter,Randomized,Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS) [ Time Frame: 4 weeks and 8 weeks after treatment ] [ Designated as safety issue: Yes ]
    To evaluate the pain in shoulder joint


Secondary Outcome Measures:
  • Fugl-Meyer scale [ Time Frame: 4 weeks and 8 weeks after treatment ] [ Designated as safety issue: Yes ]
    To evaluate the limb movement function


Other Outcome Measures:
  • Barthel index (BI) [ Time Frame: 4 weeks and 8 weeks after treatment ] [ Designated as safety issue: Yes ]
    To evaluate patient's ability in daily life


Estimated Enrollment: 90
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture with rehabilitation
Electric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks
Device: rehabilitation
rehabilitation,To treat five times a week,Total course is eight weeks
Device: Acupuncture
rehabilitation
rehabilitation,To treat five times a week,Total course is eight weeks
Device: rehabilitation
rehabilitation,To treat five times a week,Total course is eight weeks

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Ischemic stroke and shoulder hand syndrome,conscious,For 2 weeks to 6 months,Patients with I or Ⅱ period.

Exclusion Criteria:

- Disturbance of consciousness,With shoulder joint disease or muscle disease,Patients with shoulder hand syndrome Ⅲ period,Serious primary diseases such as heart,liver and kidney,Mental illness.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011854

Contacts
Contact: huang Zouqin, Dr. 021-58989669/2727 hzqmusic@yeah.net

Locations
China, Shanghai
Pudong New Area TCM Hospital Recruiting
Shanghai, Shanghai, China, 201299
Contact: Huang Zouqin, Doctor    021-58989669/2727    hzqmusic@yeah.net   
Contact: Huang Zouqin    13564599607      
Sponsors and Collaborators
Zouqin Huang
Longhua Hospital
Investigators
Study Director: Huang Zouqin, Dcctor Pudong New Area TCM Hospital
  More Information

No publications provided

Responsible Party: Zouqin Huang, Attending physician, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02011854     History of Changes
Other Study ID Numbers: PW2013A-41
Study First Received: December 10, 2013
Last Updated: December 12, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shanghai University of Traditional Chinese Medicine:
acupuncture,rehabilitation,Shoulder-hand Syndrome

Additional relevant MeSH terms:
Syndrome
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 19, 2014