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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
116
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.
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.
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Longhua hospital
Shanghai, China
The Fugl-Meyer Assessment (FMA)
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
Time frame: 8 week
The Fugl-Meyer Assessment (FMA)
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
Time frame: 16 week
modified Barthel Index (mBI)
to evaluate the daily life function, including stool, urine, dressing, using the toilet, eating, transfer, walking for 45 meters, wearing clothes, going up and down stairs, and bathing.
Time frame: 8 week, 16 week
Stroke syndrome of traditional Chinese medicine (SSTCM)
self-rating scale that reflects the quality of life of stroke patients
Time frame: 8 week, 16 week
fractional amplitude of low frequency fluctuation (fALFF)
fALFF aquired by fMRI technique measures the relative contribution of low frequency fluctuations within a specific frequency band to the whole detectable frequencyrange
Time frame: 8 week
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