Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

October 27, 2009 updated by: Tianjin University of Traditional Chinese Medicine
The purpose of this study is to evaluate the therapeutic effect of acupuncture method of "Xing Nao Kai Qiao" for paralysis as an apoplectic sequela in a multicenter randomized and controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation therapy. In addition, evaluating the trial in the view of medical economics.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center randomized controlled trial comparing three treatment groups.The trial is completed in the following three hospitals: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM) of China, Tianjin Hospital of TCM of China, and Qingdao Haici Medical group of Shangdong province of China.

The total observation period within this study is 24 weeks for each patient. All patients should remain hemiplegia within 15～90 days after stroke. After randomization the patients will receive 4 sessions of 30 minutes' duration during a period of 4 weeks. The outcome measurement is completed both in the different times as follows: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

288 patients were randomised into three groups: acupuncture group, rehabilitation group,and acupuncture plus rehabilitation group.The patients in the three groups are blinded as to which treatment method they received. The central randomization is used in this trial, which is performed by the Drug Clinical Research Center of Shanghai University of TCM of China. This trial is performed according to the principles of the Declaration of Helsinki (Version Edinburgh 2000). And the trial protocol has been approved by local institutional review board and ethics committee.

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300193
        • Recruiting
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM)
        • Contact:

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cerebral infarction diagnosed according to the diagnostic standard of western medicine
  2. Apoplexy diagnosed according to the diagnostic standard of traditional Chinese medicine for apoplexy
  3. Cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral CT or MRI
  4. The incidence of apoplexy less than twice and the time of onset 15~3 months
  5. Age: 40-75 years, non-limited gender
  6. NDS score of limb functional defect ≥10
  7. The patient was alert and the vital signs are stable
  8. Participant signed the informed consent form

Exclusion Criteria:

  1. TIA or RIND
  2. The nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease
  3. Pregnant or breast-feeding women
  4. Complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath

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
Other: acupuncture
Xing Nao Kai Qiao Acupuncture
Active Comparator: rehabilitation
Behavioral: rehabilitation
Kinesitherapy
Active Comparator: acupuncture and rehabilitation
Other: acupuncture and rehabilitation
Xing Nao Kai Qiao Acupuncture plus Kinesitherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score of neurological defect
Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Visualized anologue score
Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
Spasm evaluation
Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
Safety evaluation
Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.
before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment.

Collaborators and Investigators

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

Sponsor

Tianjin University of Traditional Chinese Medicine

Investigators

  • Study Director: Sicheng Wang, Master, State Administration of Traditional Chinese Medicine of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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, 2006

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2009

Last Update Submitted That Met QC Criteria

October 27, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTRDP- 2006BAI12B02-2

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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