Scalp Acupuncture for Dyskinesia After Ischemic Stroke
LUSA
1 other identifier
interventional
116
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2017
CompletedFirst Submitted
Initial submission to the registry
April 11, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedSeptember 7, 2022
September 1, 2022
4.7 years
April 11, 2017
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The Fugl-Meyer Assessment (FMA)
Fugl-Meyer motor function score can effectively assess the degree of dyskinesia at different times during recovery after stroke.
8 week
Secondary Outcomes (4)
The Fugl-Meyer Assessment (FMA)
16 week
modified Barthel Index (mBI)
8 week, 16 week
Stroke syndrome of traditional Chinese medicine (SSTCM)
8 week, 16 week
fractional amplitude of low frequency fluctuation (fALFF)
8 week
Study Arms (2)
Scalp acupuncture
EXPERIMENTALnumber: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.
Conventional rehabilitation
ACTIVE COMPARATORnumber:58 Rehabilitation will be conducted for 1 hour five times per week (Monday through Friday) for 8 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
Longhua hospital
Shanghai, 200032, China
Related Publications (1)
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.
PMID: 35673804DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
jian
Shanghai University of Traditional Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2017
First Posted
April 19, 2017
Study Start
January 20, 2017
Primary Completion
September 20, 2021
Study Completion
March 20, 2023
Last Updated
September 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share