Acupuncture for Post-stroke Shoulder-hand Syndrome | NCT02011854

Studies
Acupuncture for Post-stroke Shoulder-hand Syndrome

NCT02011854

Sponsor

Zouqin Huang

Status

Unknown status

Last Update Posted

Dec 13, 2013Estimated

Enrollment

90Estimated

Phase

Phase 2Phase 3

Conditions

Shoulder-hand Syndrome

Interventions

rehabilitation
Acupuncture

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Oct 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Dec 10, 2013

First Submission Date that Met QC Criteria

Dec 12, 2013

First Posted Date

Dec 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2013

Last Update Posted Date

Dec 13, 2013Estimated

Name	Class
Longhua Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture with rehabilitation	Experimental	Electric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks	Device: rehabilitation Device: Acupuncture
rehabilitation	Other	rehabilitation,To treat five times a week,Total course is eight weeks	Device: rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rehabilitation	Device	rehabilitation,To treat five times a week,Total course is eight weeks	Acupuncture with rehabilitation rehabilitation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
huang Zouqin, Dr.	Contact	021-58989669/2727		hzqmusic@yeah.net

Overall Officials

Name	Affiliation	Role
Huang Zouqin, Dcctor	Pudong New Area TCM Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pudong New Area TCM Hospital	Recruiting	Shanghai	Shanghai Municipality	201299	China

Condition Browse Module

MeSH Terms

ID	Term
D012019	Reflex Sympathetic Dystrophy

Ancestor Terms

ID	Term
D020918	Complex Regional Pain Syndromes
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided