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Acupuncture for Post-stroke Shoulder-hand Syndrome

Primary Purpose

Shoulder-hand Syndrome

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

rehabilitation

Acupuncture

About this trial

This is an interventional treatment trial for Shoulder-hand Syndrome focused on measuring acupuncture，rehabilitation,Shoulder-hand Syndrome

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pudong New Area TCM HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Acupuncture with rehabilitation

rehabilitation

Arm Description

Electric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks

rehabilitation,To treat five times a week,Total course is eight weeks

Outcomes

Primary Outcome Measures

Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS)

To evaluate the pain in shoulder joint

Secondary Outcome Measures

Fugl-Meyer scale

To evaluate the limb movement function

Full Information

NCT ID

NCT02011854

First Posted

December 10, 2013

Last Updated

December 12, 2013

Sponsor

Zouqin Huang

Collaborators

Longhua Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02011854

Brief Title

Acupuncture for Post-stroke Shoulder-hand Syndrome

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zouqin Huang

Collaborators

Longhua Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder-hand Syndrome

Keywords

acupuncture，rehabilitation,Shoulder-hand Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture with rehabilitation

Arm Type

Experimental

Arm Description

Electric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks

Arm Title

rehabilitation

Arm Type

Other

Arm Description

rehabilitation,To treat five times a week,Total course is eight weeks

Intervention Type

Device

Intervention Name(s)

rehabilitation

Intervention Description

rehabilitation,To treat five times a week,Total course is eight weeks

Intervention Type

Device

Intervention Name(s)

Acupuncture

Primary Outcome Measure Information:

Title

Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS)

Description

To evaluate the pain in shoulder joint

Time Frame

4 weeks and 8 weeks after treatment

Secondary Outcome Measure Information:

Title

Fugl-Meyer scale

Description

To evaluate the limb movement function

Time Frame

4 weeks and 8 weeks after treatment

Other Pre-specified Outcome Measures:

Title

Barthel index (BI)

Description

To evaluate patient's ability in daily life

Time Frame

4 weeks and 8 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

huang Zouqin, Dr.

Phone

021-58989669/2727

hzqmusic@yeah.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huang Zouqin, Dcctor

Organizational Affiliation

Pudong New Area TCM Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Pudong New Area TCM Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201299

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huang Zouqin, Doctor

Phone

021-58989669/2727

hzqmusic@yeah.net

First Name & Middle Initial & Last Name & Degree

Huang Zouqin

Phone

13564599607

12. IPD Sharing Statement

Learn more about this trial

Acupuncture for Post-stroke Shoulder-hand Syndrome

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