Trial Outcomes & Findings for Combining Acupuncture and Acupressure for Dementia Elderly (NCT NCT04305951)
NCT ID: NCT04305951
Last Updated: 2026-02-10
Results Overview
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.
COMPLETED
NA
236 participants
Baseline, 6 week, 12 week
2026-02-10
Participant Flow
Recruitment and treatment started in October 2021 and ended in August 2024. Elderly people with cognitive impairment or dementia of any type were recruited in 19 local elderly care homes, with 6 in Hong Kong Island, 9 in Kowloon and 4 in New Territories.
Participant milestones
| Measure |
Routine Care Group
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
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
CAE Group
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
59
|
59
|
|
Overall Study
COMPLETED
|
55
|
46
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
13
|
8
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
85.3 year
STANDARD_DEVIATION 7.2 • n=59 Participants
|
82.6 year
STANDARD_DEVIATION 8.8 • n=59 Participants
|
84.8 year
STANDARD_DEVIATION 8.7 • n=59 Participants
|
84.6 year
STANDARD_DEVIATION 8.6 • n=59 Participants
|
84.3 year
STANDARD_DEVIATION 8.3 • n=236 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=59 Participants
|
30 Participants
n=59 Participants
|
35 Participants
n=59 Participants
|
31 Participants
n=59 Participants
|
137 Participants
n=236 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=59 Participants
|
29 Participants
n=59 Participants
|
24 Participants
n=59 Participants
|
28 Participants
n=59 Participants
|
99 Participants
n=236 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
MoCA
|
8.8 score
STANDARD_DEVIATION 5.9 • n=59 Participants
|
10.5 score
STANDARD_DEVIATION 7.3 • n=59 Participants
|
10.9 score
STANDARD_DEVIATION 7.3 • n=59 Participants
|
10.1 score
STANDARD_DEVIATION 6.3 • n=59 Participants
|
10.1 score
STANDARD_DEVIATION 6.7 • n=236 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.
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.
Outcome measures
| Measure |
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
|---|---|---|---|---|
|
Changes in the Montreal Cognitive Assessment Score
Week 6
|
1.06 score
Interval 0.13 to 1.99
|
0.44 score
Interval -0.37 to 1.25
|
0.14 score
Interval -0.75 to 1.02
|
0.70 score
Interval -0.18 to 1.59
|
|
Changes in the Montreal Cognitive Assessment Score
Week 12
|
1.33 score
Interval 0.4 to 2.26
|
0.40 score
Interval -0.44 to 1.23
|
-0.25 score
Interval -1.11 to 0.62
|
0.60 score
Interval -0.28 to 1.49
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.
Severity of dementia is measured using Digit Span Forward and its overall score ranges from 0 to 14. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.
Outcome measures
| Measure |
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
|---|---|---|---|---|
|
Change in the Digit Span Forward
Week 6
|
0.01 score
Interval -0.68 to 0.7
|
0.37 score
Interval -0.28 to 1.01
|
0.04 score
Interval -1.01 to 1.09
|
-0.15 score
Interval -0.97 to 0.67
|
|
Change in the Digit Span Forward
Week 12
|
-0.01 score
Interval -0.71 to 0.68
|
0.30 score
Interval -0.37 to 0.97
|
-1.59 score
Interval -2.61 to -0.56
|
-0.61 score
Interval -1.43 to 0.21
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.
Severity of dementia is measured using Digit Span Reverse and its overall score ranges from 0 to 14. A higher score indicates better cognition. Assessments will be conducted at baseline and once every six weeks thereafter.
Outcome measures
| Measure |
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
|---|---|---|---|---|
|
Change in the Digit Span Reverse
Week 6
|
0.10 score
Interval -0.36 to 0.57
|
0.15 score
Interval -0.35 to 0.65
|
-0.04 score
Interval -0.53 to 0.44
|
-0.43 score
Interval -0.92 to 0.07
|
|
Change in the Digit Span Reverse
Week 12
|
0.47 score
Interval 0.0 to 0.94
|
0.23 score
Interval -0.28 to 0.74
|
-0.23 score
Interval -0.7 to 0.25
|
0.02 score
Interval -0.48 to 0.51
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.
Functional independence is measured using Modified Bathel Index (MBI) and its overall score ranges from 10 to 50. A higher score indicates better functional independence. Assessments will be conducted at baseline and once every six weeks thereafter.
Outcome measures
| Measure |
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
|---|---|---|---|---|
|
Changes in the Modified Bathel Index Score
Week 6
|
0.94 score
Interval -0.61 to 2.49
|
0.68 score
Interval -1.12 to 2.48
|
0.82 score
Interval -1.33 to 2.96
|
1.97 score
Interval -0.5 to 4.43
|
|
Changes in the Modified Bathel Index Score
Week 12
|
0.57 score
Interval -1.0 to 2.13
|
1.82 score
Interval -0.02 to 3.67
|
-0.93 score
Interval -3.04 to 1.17
|
3.11 score
Interval 0.63 to 5.59
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.
Pain is evaluated using visual analogue scale (VAS) and its overall score ranges from 0 to 10. A higher score indicates greater severity. Assessments will be conducted at baseline and once every six weeks thereafter.
Outcome measures
| Measure |
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
|---|---|---|---|---|
|
Changes in the Visual Analogue Scale Score
Week 6
|
0.01 score
Interval -0.65 to 0.67
|
-0.57 score
Interval -1.2 to 0.06
|
0.11 score
Interval -0.6 to 0.81
|
-0.43 score
Interval -1.09 to 0.23
|
|
Changes in the Visual Analogue Scale Score
Week 12
|
-0.49 score
Interval -1.17 to 0.18
|
-0.32 score
Interval -0.97 to 0.33
|
-0.18 score
Interval -0.87 to 0.51
|
-0.23 score
Interval -0.9 to 0.44
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.
Depressive symptoms are measured using the 15-item Geriatric Depression Scale (GDS-15) and its overall score ranges from 0 to 15. A higher score indicates greater severity. Assessments will be conducted at baseline and once every six weeks thereafter.
Outcome measures
| Measure |
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
|---|---|---|---|---|
|
Changes in the Geriatric Depression Scale Score
Week 6
|
-1.23 score
Interval -2.32 to -0.13
|
-0.62 score
Interval -1.53 to 0.3
|
-0.49 score
Interval -1.7 to 0.71
|
-0.67 score
Interval -1.73 to 0.4
|
|
Changes in the Geriatric Depression Scale Score
Week 12
|
-1.85 score
Interval -2.99 to -0.72
|
-0.75 score
Interval -1.67 to 0.18
|
-1.47 score
Interval -2.68 to -0.26
|
-0.39 score
Interval -1.45 to 0.66
|
SECONDARY outcome
Timeframe: Baseline, 6 week, 12 weekPopulation: The efficacy was analyzed in the intention-to-treat population, defined as participants who have been randomized.
Sleep parameters are measured using Insomnia Severity Index (ISI) and its overall score ranges from 0 to 28. A higher score indicates more acute sleep disturbances. Assessments will be conducted at baseline and once every six weeks thereafter.
Outcome measures
| Measure |
CAE Group
n=59 Participants
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 Participants
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
Routine Care Group
n=59 Participants
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
n=59 Participants
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
|---|---|---|---|---|
|
Changes in the Insomnia Severity Index Score
Week 6
|
-0.38 score
Interval -1.91 to 1.15
|
-0.50 score
Interval -1.57 to 0.57
|
-0.12 score
Interval -1.71 to 1.48
|
-0.45 score
Interval -1.72 to 0.83
|
|
Changes in the Insomnia Severity Index Score
Week 12
|
-1.46 score
Interval -3.03 to 0.12
|
-0.84 score
Interval -1.95 to 0.28
|
-0.67 score
Interval -2.26 to 0.93
|
-1.26 score
Interval -2.56 to 0.05
|
Adverse Events
Routine Care Group
CAT Group
CAE Group
CAT + CAE Group
Serious adverse events
| Measure |
Routine Care Group
n=59 participants at risk
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
n=59 participants at risk
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
CAE Group
n=59 participants at risk
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 participants at risk
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
COVID-19 infection
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Patent foramen ovale-associated platypnea-orthodeoxia syndrome
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Endocrine disorders
Diabetes
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
General disorders
Fall
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
3.4%
2/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Investigations
Fatigue
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Heart failure
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
3.4%
2/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
Other adverse events
| Measure |
Routine Care Group
n=59 participants at risk
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
n=59 participants at risk
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
|
CAE Group
n=59 participants at risk
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
|
CAT + CAE Group
n=59 participants at risk
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
|
|---|---|---|---|---|
|
Infections and infestations
Fever
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
5.1%
3/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
General disorders
Hematoma around the site of needling
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
6.8%
4/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
8.5%
5/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
5.1%
3/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
General disorders
Bleeding at the site of needling
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
11.9%
7/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
6.8%
4/59 • from enrollment until end of follow-up, up to 12 weeks
|
|
General disorders
Fall
|
1.7%
1/59 • from enrollment until end of follow-up, up to 12 weeks
|
5.1%
3/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/59 • from enrollment until end of follow-up, up to 12 weeks
|
Additional Information
Zhang Zhangjin, Professor
School of Chinese Medicine, University of Hong Kong
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place