Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Ischemic Stroke Patients

Ischemic Stroke Clinical Trial

Official title:

Scalp Acupuncture for Motor Dysfunction in Ischemic Stroke: a Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871453
• Other study ID #: ZYSNXD-CC-HPGC-JD-004
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Jian Pei, MD
• Phone: 021-64385700
• Email: jianpei99[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Hemiplegia
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Scalp Acupuncture Treatment
The Motor Area of the scalp acupuncture is located over the anterior central convolution of the cerebral cortex, being a line starting from a point 0.5cm posterior to the midpoint of the anterior-posterior midline of the head and stretching diagonally to the juncture between the eyebrow-occipital line and the anterior border of the corner of temporal hairline is indistinct, draw a vertical line upward from the middle point of the zygomatic arch to the eyebrow-occipital line, the intersection of the two lines is the projection of the Motor Area. Needles will be inserted in an about 15 degree angle to a depth of 1.0-1.5cm. Needles are rotated at least 200 revolutions per minute for 1 minute every 10 minutes for a total of 60 minutes. five times a week, 8 weeks in total.

Other:
• Rehabilitation treatment
The rehabilitation program was designed according to the Chinese stroke rehabilitation treatment guidelines, which included physical therapy (PT) and occupational therapy (OT). The rehabilitation programs will be carried out five times a week (that is, Monday to Friday) for 8 weeks, and every time the rehabilitation treatment( PT and OT) will last approximately for 1 hour. All rehabilitation treatment will be carried out by qualified therapists.

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of Traditional Chinese Medicine	ShangHai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline FMA at 4 weeks, 8 weeks	The Fugl-Meyer Assessment (FMA) scale for motor function, the FMA was developed as the first quantitative evaluative instrument for measuring sensorimotor stroke recovery, which includes an assessment of the upper extremity (UE, 66 points) and lower extremity (LE, 34 points). The motor domain has well-established reliability and validity as an indicator of motor impairment severity across different stroke recovery time points	The FMA will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
Secondary	Change from Baseline MBI at 4 weeks, 8 weeks	The Barthel Index(BI) is a scale that measures ten basic aspects of activity daily living related to self-care and mobility. For the Chinese Modified Barthel Index(MBI) version, the ten items are: continence of bowels and bladder, feeding, dressing, transferring to and from a toilet, grooming, bathing, moving from wheelchair to bed and return, walking on level surface for 45 meters, and ascend and descend stairs. Standard for Evaluation:Each item (activity) be divided into 5 levels, different level represents a different degree of independence, the lowest level is 1 and the highest level is 5.The more higher level, more independence. The normal score is 100. If a person score is 100, he is able to get along without attendant care.	The MBI will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
Secondary	Change from Baseline SS-QOL at 4 weeks, 8 weeks	The Stroke-Specific Quality of Life Scale (SS-QOL) is a patient-reported outcome measure intended to provide an assessment of health-related quality of life, specific to patients with stroke. The SS-QOL questionnaire consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work. Scoring of the SS-QOL is rated on a 5-point Likert scale. Response options are scored as 5 ("no help needed/no trouble at all/strongly disagree"), 4 ("a little help/a little trouble/moderately disagree"), 3 ("some help/some trouble/neither agree nor disagree"), 2 ("a lot of help/a lot of trouble/moderately agree"), and 1 ("total help/could not do it at all/strongly agree"). The domains are scored separately, and a total score is also calculated, with higher scores indicating better function.	The SS-QOL will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).
Secondary	Change from Baseline SSTCM at 4 weeks, 8 weeks	The Stroke Syndrome of TCM (SSTCM) was developed mainly based on quantified index of TCM symptoms. The SSTCM includes signs and symptoms which were the most concern of the patients and doctors themselves after stroke. SSTCM mainly consists of two domains: TCM symptoms and pulse conditions and tongue pictures. TCM symptoms area contains 24 items. The assessment standards of each item was divided into four levels and corresponding scores (normal = 0, light = 1, middle=2, heavy = 3) according different degree base on the severity of the symptoms and the impacts on life. Pulse conditions and tongue pictures record contents only, not to score. The total score is calculated from the domain one, with lower scores indicating the lighter degree of the symptom severity and the less impact on life. The SSTCM was evaluated by experienced traditional Chinese medicine doctors who were accepted the unification of assessment training.	The SSTCM will be assessed at baseline, interventions period (4 weeks, 8 weeks) and fellow-up period at (1 month, 2 months).