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

NCT ID: NCT02871453

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Ischemic Stroke; Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture combined rehabilitation

Scalp acupuncture treatment

Rehabilitation treatment

Group Type: EXPERIMENTAL

Scalp Acupuncture Treatment

Intervention Type: DEVICE

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.

Rehabilitation

Rehabilitation treatment

Group Type: EXPERIMENTAL

Rehabilitation treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Acupuncture

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Pei, MD

Role: STUDY_CHAIR

Shanghai University of Traditional Chinese Medicine

Locations

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Pei, MD

Role: CONTACT

jianpei99@yahoo.com

021-64385700 ext. 3534

Facility Contacts

Jian Pei, MD

Role: primary

jianpei99@yahoo.com

+86 21 6438 5700 ext. 3534

References

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.

Reference Type: DERIVED

PMID: 28633675 (View on PubMed)

Other Identifiers

ZYSNXD-CC-HPGC-JD-004

Identifier Type: -

Identifier Source: org_study_id