Combining Acupuncture and Acupressure for Dementia Elderly

NCT04305951 | Completed Results

• 1 other identifier: UW 19-821
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This is an assessor-blinded, randomized controlled trial. A total of 248 (anticipated) elderly people aged ≥65 years with a mild to moderate dementia will be recruited from local nursing and care homes. They will be randomly assigned to routine care, CAT, CAE, and CAT+CAE with n = 62 subjects in each group. Subjects assigned to CAT, CAE, and CAT+CAE will respectively receive 2 sessions of CAT, 3 sessions of CAE, and a combination of both per week for 12 weeks. The primary outcome is the baseline-to-endpoint change in score of the Montreal Cognitive Assessment (MoCA). Secondary outcomes include various domains of MoCA, functional independence, psychological well-being, sleep quality, and level of pain. A generalized linear mixed-effect model will be used to compare outcomes over time among the four groups.

Conditions

Dementia

Keywords

Dementia; Cognitive impairment; Elderly; Acupuncture; CAT; Acupressure; CAE

Outcome Measures

Primary Outcomes (1)

• Changes in the Montreal Cognitive Assessment Score

  Severity of dementia is primarily measured using Montreal Cognitive Assessment (MoCA) and its overall score ranges from 0 to 30. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.

  Baseline, 6 week, 12 week

Secondary Outcomes (6)

• Change in the Digit Span Forward

  Baseline, 6 week, 12 week

• Change in the Digit Span Reverse

  Baseline, 6 week, 12 week

• Changes in the Modified Bathel Index Score

  Baseline, 6 week, 12 week

• Changes in the Visual Analogue Scale Score

  Baseline, 6 week, 12 week

• Changes in the Geriatric Depression Scale Score

  Baseline, 6 week, 12 week

Study Arms (4)

Routine care group

NO INTERVENTION

Subjects assigned to this group will continue their routine care without receiving any acupuncture and acupressure treatment during the study period. The routine care may include physiotherapy and intellectual activities. Post-trial treatment of either CAT, CAE, or CAT+CAE will be offered to serve as a compensation for their participation.

CAT group

EXPERIMENTAL

Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.

Procedure: Comprehensive acupuncture therapy (CAT)

CAE group

EXPERIMENTAL

Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.

Procedure: Comfy Acupressure for the Elderly (CAE)

CAT + CAE group

EXPERIMENTAL

Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.

Procedure: Comprehensive acupuncture therapy (CAT); Procedure: Comfy Acupressure for the Elderly (CAE)

Interventions

Comprehensive acupuncture therapy (CAT) PROCEDURE

CAT will be conducted for 2 sessions per week for 12 consecutive weeks. The following 14 body acupoints with only manual stimulation will be used: HT7 (Shenmen), LI4 (Hegu), TH5 (Waiguan), ST36 (Zusanli), ST40 (Fenglong) and SP6 (Sanyinjiao) in two sides, and CV12 (Zhongwan) and CV4 (Guanyuan) in midline. Electrical stimulation will be conducted on the following frontal acupoints: GV20 (Baihui), EX-HN3 (Yintang), GB15 (Toulinqi), GB8 (Shuaigu), EX-HN5 (Taiyang), and ST8 (Touwei) on two sides, and left and right EX-HN1 (Sishencong). Disposable acupuncture needles (0.25 mm in diameter and 25-40 mm in length) will be inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation is additionally delivered on the 6 pairs of the frontal acupoints. Each session of treatment will last 30 minutes.

CAT + CAE group; CAT group

Comfy Acupressure for the Elderly (CAE) PROCEDURE

CAE intervention will be conducted for 3 times per week for 12 consecutive weeks. CAE consists of 12 steps which need about 15 minutes to complete and mainly concentrates on the acupoints on face, head, neck, and shoulder. The detailed CAE Operation Guide will be provided for the provider and the video demonstration is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM.

CAE group; CAT + CAE group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• have a clinical diagnosis of any type of dementia or met the criteria of major and mild neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and
• have mild to moderate dementia at a stage of 3-5 on the Global Deterioration Scale (GDS).

You may not qualify if:

• have of dementia with the stage below 3 or above 5 on the GDS;
• have severe skin lesions on acupuncture and acupressure areas;
• have significant bleeding tendency;
• have heart pacemaker or implantable cardioverter defibrillator;
• are currently receiving acupressure as a regular therapy;
• had a surgery on the head or neck;
• are currently receiving anti-coagulant treatment.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, 000000, Hong Kong

Location

Related Publications (19)

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MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Zhang Zhangjin, Professor
• Organization: School of Chinese Medicine, University of Hong Kong

zhangzj@hku.hk

85239176445

Study Officials

• Zhang-Jin Zhang, MMed, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Director (Clinical Affairs)

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: October 5, 2021
• Primary Completion: August 27, 2024
• Study Completion: February 28, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)