Scalp Acupuncture for Dyskinesia After Ischemic Stroke (LUSA)

Shanghai University of Traditional Chinese Medicine

Status: Active, not recruiting

Conditions: Ischemic Stroke

Treatments: Other: Scalp acupuncture; Other: Conventional rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03120650

LUS64385700

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

Scalp acupuncture

Experimental group

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.

Treatment:

Other: Scalp acupuncture

Conventional rehabilitation

Active Comparator group

Description:

number:58 Rehabilitation will be conducted for 1 hour five times per week (Monday through Friday) for 8 weeks.

Treatment:

Other: Conventional rehabilitation