Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Tianjin University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tianjin University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01003470
First received: October 27, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cerebral Infarction
Other: acupuncture
Behavioral: rehabilitation
Other: acupuncture and rehabilitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Tianjin University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visualized anologue score [ Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. ] [ Designated as safety issue: Yes ]
  • Spasm evaluation [ Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. ] [ Designated as safety issue: Yes ]
  • Safety evaluation [ Time Frame: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 288
Study Start Date: October 2006
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003470

Contacts
Contact: Lixin Fu, M.D. 86-13821316617 fulixin66@126.com

Locations
China, Tianjin
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM) Recruiting
Tianjin, Tianjin, China, 300193
Contact: Lixin Fu, M.D.    86-13821316617    fulixin66@126.com   
Sponsors and Collaborators
Tianjin University of Traditional Chinese Medicine
Investigators
Study Director: Sicheng Wang, Master State Administration of Traditional Chinese Medicine of China
  More Information

Additional Information:
Publications:
Responsible Party: Ministry of Science and Technology of the People's Republic of China, State Administration of Traditional Chinese Medicine of China
ClinicalTrials.gov Identifier: NCT01003470     History of Changes
Other Study ID Numbers: KTRDP- 2006BAI12B02-2
Study First Received: October 27, 2009
Last Updated: October 27, 2009
Health Authority: China: Ministry of Health

Keywords provided by Tianjin University of Traditional Chinese Medicine:
cerebral infarction
Paralysis
acupuncture
rehabilitation
trial

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014