Acupuncture for Post-stroke Shoulder-hand Syndrome

December 12, 2013 updated by: Zouqin Huang

Acupuncture and Traditional Chinese Medicine Combined With Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome in Community Hospital: a Multicenter，Randomized，Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201299
        • Recruiting
        • Pudong New Area TCM Hospital
        • Contact:
        • Contact:
          • Huang Zouqin
          • Phone Number: 13564599607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture with rehabilitation
Electric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks
Device: Acupuncture
Device: rehabilitation
rehabilitation,To treat five times a week,Total course is eight weeks
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS)
Time Frame: 4 weeks and 8 weeks after treatment
To evaluate the pain in shoulder joint
4 weeks and 8 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer scale
Time Frame: 4 weeks and 8 weeks after treatment
To evaluate the limb movement function
4 weeks and 8 weeks after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index (BI)
Time Frame: 4 weeks and 8 weeks after treatment
To evaluate patient's ability in daily life
4 weeks and 8 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zouqin Huang

Collaborators

Longhua Hospital

Investigators

  • Study Director: Huang Zouqin, Dcctor, Pudong New Area TCM Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 13, 2013

Study Record Updates

Last Update Posted (Estimate)

December 13, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PW2013A-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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