Scalp Acupuncture for Dyskinesia After Ischemic Stroke

Not Applicable

Active, not recruiting

• Conditions: Ischemic Stroke
• Interventions: Other: Conventional rehabilitation; Other: Scalp acupuncture

• Registration Number: NCT03120650
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2017-01-20
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-19
• Primary Completion: 2021-09-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07
• Study Completion: 2023-03-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional rehabilitation	Conventional rehabilitation	number:58 Rehabilitation will be conducted for 1 hour five times per week (Monday through Friday) for 8 weeks.
Scalp acupuncture	Scalp acupuncture	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.

Primary Outcome Measures

Name	Time	Method
The Fugl-Meyer Assessment (FMA)	8 week	Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.

Secondary Outcome Measures

Name	Time	Method
Stroke syndrome of traditional Chinese medicine (SSTCM)	8 week, 16 week	self-rating scale that reflects the quality of life of stroke patients
modified Barthel Index (mBI)	8 week, 16 week	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.
fractional amplitude of low frequency fluctuation (fALFF)	8 week	fALFF aquired by fMRI technique measures the relative contribution of low frequency fluctuations within a specific frequency band to the whole detectable frequencyrange
The Fugl-Meyer Assessment (FMA)	16 week	Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.

Trial Locations

Locations (2)

Longhua hospital; 🇨🇳 Shanghai, China

Longhua Hospital, Shanghai University of Traditional Chinese Medicine; 🇨🇳 ShangHai, Shanghai, China