Clinical trial NCT03120650: Scalp Acupuncture for Dyskinesia After Ischemic Stroke
Official title: Scalp Acupuncture for Dyskinesia After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2017-04-19
Enrollment: 116
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scalp acupuncture formed by combining traditional Chinese acupuncture techniques and modern theories in medical anatomy has been widely used to treat ischemic stroke in China, but effective clinical trials that verify its efficacy are lacking. This study proposes to verify the effects of Lu's scalp acupuncture on ischemic stroke by comparing differential improvement of motor function between conventional rehabilitation alone and conventional rehabilitation with Lu's scalp acupuncture.

Detailed description: A randomized, controlled, parallel, clinical trial. 116 ischemic stroke patients will be collected with dyskinesia from Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Huashan Hospital, Fudan University in China. All patients will be equally randomized into either a control group (conventional rehabilitation) or an experimental group (scalp acupuncture + conventional rehabilitation). In the control group, patients will receive conventional rehabilitation according to the Guidelines for Stroke Rehabilitation in China. In the experimental group, conventional rehabilitation will be supplemented with oblique acupuncture at approximately 15° and an insertion depth of 25-35 mm in the motor areas of the scalp. Twisting speed will be 200 times per minute. Acupuncture will be performed six times per day in 1-minute bouts, with a 4-minute rest following each bout. Patients in both groups will receive rehabilitation five times per week for 8 consecutive weeks. The primary outcome will be the difference in Fugl-Meyer motor function score between posttreatment (4 weeks, 8 weeks, and 6 months of follow-up) and baseline.

The secondary outcomes will be differences in the Modified Barthel Index, stroke-specific quality of life, and stroke syndrome of traditional Chinese medicine.

Eligibility criteria: Inclusion Criteria:

* Meet to criteria for diagnosis and efficacy evaluation of stroke, formulated by The State Administration of Traditional Chinese Medicine Encephalopathy Emergency Cooperative Group in 1996 (trial implementation)

  * Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China in 2014 (Neurology Branch of Chinese Medical Association and Cerebrovascular Disease Association of Neurology Branch of Chinese Medical Association, 2015)
  * Ischemic stroke diagnosed by CT or magnetic resonance imaging (MRI), with the presence of stable vital signs and awareness
  * An age of 40-70 years Onset within 1-6 months
  * Motor dysfunction in the extremities
  * A Mini-Mental State Examination (Pangman et al., 2000) score \> 24 points

Exclusion Criteria:

* Consciousness disorder or severe cognitive impairment

  * Severe Parkinson's disease, heart disease, cancer, epilepsy, or chronic alcoholism
  * Hepatic or renal impairment
  * Hemorrhagic tendency
  * Sensitivity to acupuncture
  * Congenital disability
  * Pregnancy
  * Currently participating in other clinical trials

Primary outcomes:
measure: The Fugl-Meyer Assessment (FMA)
timeFrame: 8 week
Secondary outcomes:
measure: The Fugl-Meyer Assessment (FMA)
timeFrame: 16 week
measure: modified Barthel Index (mBI)
timeFrame: 8 week, 16 week
measure: Stroke syndrome of traditional Chinese medicine (SSTCM)
timeFrame: 8 week, 16 week
measure: fractional amplitude of low frequency fluctuation (fALFF)
timeFrame: 8 week
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Longhua hospital
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: jian
role: STUDY_DIRECTOR
References:
citation: Zhan Y, Pei J, Wang J, Fu Q, Xu J, Yan M, Cai Y, Cui X, Ye W, Fan M, Yu Q, Jia J. Motor function and fALFF modulation in convalescent-period ischemic stroke patients after scalp acupuncture therapy: a multi-centre randomized controlled trial. Acupunct Med. 2023 Apr;41(2):86-95. doi: 10.1177/09645284221086289. Epub 2022 Jun 7.