Clinical trial NCT02871453: Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Ischemic Stroke Patients
Official title: Scalp Acupuncture for Motor Dysfunction in Ischemic Stroke: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Hemiplegia
Keywords: Ischemic Stroke
Motor Dysfunction
Scalp Acupuncture
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2016-08-18
Enrollment: 116
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators design a randomized, control study to evaluate the therapeutic effect of scalp acupuncture using Jiao's motor area for motor dysfunction in ischemic stroke patients using the following outcomes: motor function, activity of daily living,quality of life.

Detailed description: Functional disorder is a common and serious consequence of stroke. A large proportion of stroke patients develop motor dysfunction in the early stage after stroke. Acupuncture is often used as an adjunct to mainstream rehabilitation after stroke. Jiao's scalp acupuncture is a contemporary acupuncture technique integrating traditional Chinese needling methods with western medical knowledge of representative areas of the cerebral cortex. It has been widely applied to be a kind of effective treatment for stroke in China. But, there is meta-analysis suggests that with stroke rehabilitation, acupuncture has no additional effect on motor recovery but has a small positive effect on disability, which may be due to a true placebo effect and varied study quality. The efficacy of acupuncture without stroke rehabilitation remains uncertain, mainly because of the poor quality of such studies.

The objective of this proposed study is to determine whether scalp acupuncture treatment could improve significantly motor function in ischemic stroke patients.

In this 8-week, assessor-blind, randomized, controlled study of scalp acupuncture as additional treatment with the rehabilitation treatment, a total of 116 patients with ischemic stroke patients will be recruited. The patients will be randomly assigned to scalp acupuncture combined with rehabilitation treatment (n =58) or rehabilitation treatment (n =58). (40 sessions, 5 sessions a week). Changes in the motor function over time are measured using Fugl-Meyer Scale, Modified Barthel Index and SS-QOL scale. The study will be conducted at Shanghai University of Traditional Chinese Medicine, Long Hua Hospital, Fudan University, Hua Shan Hospital.

Eligibility criteria: Inclusion Criteria:

1. The ages of stroke patients from 40 years old to 70 years old
2. Stroke diagnosed according to the criteria of cerebral arterial thrombosis in Western medicine and apoplexy in Chinese medicine
3. Ischemic stroke confirmed by CT brain or MRI brain, with stable medical condition and awareness clear
4. Recent stroke from 1 month to 6 months after onset
5. Stroke with limb motor dysfunction
6. Sufficient cognition to follow commands and Mini-Mental State Examination (MMSE) score \> 24
7. Voluntary participation and informed consent signed.

Exclusion Criteria:

1. Stroke with conscious disturbance or serious cognitive impairment
2. Presence of another chronic disorder, including severe Parkinson's disease, cardiac disease, cancers, epilepsy, or chronic alcoholism
3. Impaired hepatic or renal function
4. bleeding tendency
5. Being oversensitive to acupuncture
6. participation in another clinical trial.

Primary outcomes:
measure: Change from Baseline FMA at 4 weeks, 8 weeks
timeFrame: The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
Secondary outcomes:
measure: Change from Baseline MBI at 4 weeks, 8 weeks
timeFrame: The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
measure: Change from Baseline SS-QOL at 4 weeks, 8 weeks
timeFrame: The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
measure: Change from Baseline SSTCM at 4 weeks, 8 weeks
timeFrame: The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jian Pei, MD
role: STUDY_CHAIR
References:
citation: Wang J, Pei J, Khiati D, Fu Q, Cui X, Song Y, Yan M, Shi L, Cai Y, Ma Y. Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial. Trials. 2017 Jun 20;18(1):287. doi: 10.1186/s13063-017-2000-x.