The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke

NCT04971603 | Unknown DMC

• 1 other identifier: Acupuncture for stroke
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke and its sequelae are a major indication for acupuncture. The specific aims of this study are to assess the feasibility of pragmatic clinical trial on acupuncture in primary care setting and evaluate the effectiveness and safety of acupuncture for stroke rehabilitation in Hong Kong.

Conditions

Stroke

Keywords

Stroke; Chinese Medicine; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Activities of daily living (ADL) scores

  ADL is commonly utilized to indicate the patient's functioning condition and level of care assistance by the Hospital Authority in Hong Kong.

  9 months

Secondary Outcomes (3)

• Mini-mental state examination (MMSE)

  9 months

• Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)

  9 months

• Constitution in Chinese Medicine Questionnaire (CCMQ)

  9 months

Study Arms (1)

Acupuncture treatment group

EXPERIMENTAL

The patients will receive 24-week acupuncture treatment and 12-week follow up. Seven visits will be arranged within the 24-wk treatment period and at the end of study at wk 6, 10, 14, 18, 22, 26 and 38 for medical consultation and investigation.

Other: Acupuncture

Interventions

Acupuncture OTHER

All acupuncture operations were done by registered Chinese medicine practitioner. Sterile, disposable acupuncture needles (0.25mmin diameter and 40mmin length) were used, which were purchased from HuaTuo acupuncture instrument. Principal points: Neiguan (PC 6) \*, Sanyinjia (SP 6) \*, Weizhong (BL 40) \*, Baihui (GV 20), Shuigou (GV 26) \*, Zusanli (ST 36) \*, Quchi (LI 11) \*, Waiguan (TE 5) \*, Hegu (LI 4) \*, Huantiao (GB 30) \*, Yanglingquan (GB 34)\* (Grading of recommendation: C, level of evidence: IV). Supplementary points: If upper limbs hemiplegia occurs, add Jianliao (TE 14) and Shousanli (LI 10); if lower limbs hemiplegia occurs, add Xuanzhong (GB 39) and Taichong (LR 3); if a deviation of the mouth or tongue occurs, add Dicang (ST 4) and Jiache (ST 6).

Acupuncture treatment group

Eligibility Criteria

• Age: 35 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants who meet the following criteria will be included: (1) 35\~90 years or older; (2) discharged from hospital; (3) diagnosed with cerebral hemorrhage or cerebral infarction through brain computed tomography (CT) or magnetic resonance imaging (MRI); (4) stable vital signs; and (5) voluntary participation with informed consents signed in this study.

You may not qualify if:

• \- The following participants are excluded: (1) patients with unconsciousness, aphasia, and cognitive dysfunction (Mini-Mental State Examination-Korean version (MMSE-K) \<24); (2) those with a past history of brain disease (e.g., mental illness, consciousness disorder due to head trauma, previous brain surgery, or spastic disease); (3) those with severe heart, liver, or kidney disease or bleeding disorders; (4) those with other serious diseases (e.g., cancer, dementia (Alzheimer's disease or dementia of Lewy body), Parkinson's disease, and Parkinson's syndrome); (5) those who participated in other clinical trials within last three months; (6) those with needle phobia; and (7) pregnant or lactating female patients.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Hong Kong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Linda Zhong, MD.,PH.D

CONTACT

852-34116523; ldzhong0305@gmail.com

Zhaoxiang Bian, MD.,PH.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm prospective study. A total of 500 eligible patients will be recruited for 24-week treatment and 12-week follow up.

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 21, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: July 21, 2021

Record last verified: 2021-01

Locations

HK (1)