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.
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.
- Conventional rehabilitation Procedure
Intervention Desc: Rehabilitation plans will be made according to the Guidelines for Stroke Rehabilitation in China (Cerebrovascular Disease Association and the Neurological Rehabilitation Association of Neurology Branch of the Chinese Medical Association, 2012), including physical therapy and occupational therapy. ARM 1: Kind: Experimental Label: Conventional rehabilitation Description: number:58 Rehabilitation will be conducted for 1 hour five times per week (Monday through Friday) for 8 weeks.
- Scalp acupuncture Other
Intervention Desc: Acupoint selection: Shenting (DU24; Baihui (DU20; and upper 1/5 and middle 2/5 in the contralateral motor area (upper: 0.5 cm posterior to the midpoint of the front and rear midline; middle 2/5: intersection between the eyebrow line and the leading edge of the temple hairline. ARM 1: Kind: Experimental Label: Scalp acupuncture Description: number:58 The needle will be maintained in place for 30 minutes. Patients in both groups will receive rehabilitation five times per week (Monday through Friday) for 8 consecutive weeks.
|Type||Measure||Time Frame||Safety Issue|
|Primary||The Fugl-Meyer motor function score||3year|
|Secondary||Modified Barthel Index||3year|
|Secondary||Stroke syndrome of traditional Chinese medicine (SSTCM)||3year|