NCT02011854

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.

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
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

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

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

3 years

First QC Date

December 10, 2013

Last Update Submit

December 12, 2013

Conditions

Keywords

acupuncture,rehabilitation,Shoulder-hand Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Fugl-Meyer scale

    4 weeks and 8 weeks after treatment

Other Outcomes (1)

  • Barthel index (BI)

    4 weeks and 8 weeks after treatment

Study Arms (2)

Acupuncture with rehabilitation

EXPERIMENTAL

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

Device: rehabilitationDevice: Acupuncture

rehabilitation

OTHER

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

Device: rehabilitation

Interventions

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

Acupuncture with rehabilitationrehabilitation
Acupuncture with rehabilitation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pudong New Area TCM Hospital

Shanghai, Shanghai Municipality, 201299, China

RECRUITING

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy

Interventions

RehabilitationAcupuncture Therapy

Condition Hierarchy (Ancestors)

Complex Regional Pain SyndromesAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesComplementary Therapies

Study Officials

  • Huang Zouqin, Dcctor

    Pudong New Area TCM Hospital

    STUDY DIRECTOR

Central Study Contacts

huang Zouqin, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 13, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations