Combining Acupuncture and Acupressure for Dementia Elderly
NCT ID: NCT04305951
Last Updated: 2025-04-03
Study Results
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Basic Information
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COMPLETED
NA
236 participants
INTERVENTIONAL
2021-10-05
2025-02-28
Brief Summary
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Detailed Description
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Acupuncture has been widely used in the local clinical practice. Numerous studies have shown the benefits of acupuncture in reducing cognitive deterioration in patients with cognitive impairment and dementia and animal models. Acupuncture is also effective in improving physical disability, rigidity, gait, and postural balance in aging adults with stroke and Parkinson's disease. A large body of evidence further confirms the effectiveness of various acupuncture regimens in treating pain, fatigue, sleep disturbance, anxiety, and depression. On the other hand, it is well demonstrated that, as a convenient therapy, acupressure has particular benefits in alleviating sleep disturbance, anxiety, depression, and agitation in elderly with dementia. Acupressure also has positive effects on the recovery of motor function and daily activities of stroke patients. These studies suggest that acupuncture and acupressure could produce benefits for the elderly with dementia.
Most recently, we have completed three clinical trials that evaluated the efficacy of acupuncture treatment of vascular dementia; stroke-caused cognitive deterioration , and chemotherapy-induced cognitive impairment. All these trials have consistently revealed that acupuncture was effective in alleviating cognitive impairment. We also have shown the effectiveness of a caregiver-performed acupressure on the general quality of life in frail older people and self-administered acupressure for insomnia disorder. The caregiver-performed acupressure protocol is called 'Comfy Acupressure for the Elderly (CAE)' and demonstration video is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM. Furthermore, our several studies have confirmed the efficacy of acupuncture in improving major depression ; insomnia and anxiety, poststroke depression and movement disability. Meanwhile, we have developed a novel acupuncture mode called comprehensive acupuncture therapy (CAT) that consists of dense frontal acupoints with additional electrical stimulation and multiple body acupoints. The efficacy of CAT has been well proven in our previous studies.
The working hypothesis is that CAT and CAE are feasible, safe, and could produce better management outcomes than routine care in improving cognitive impairment, frailty-related disability and dependency as well as comorbid symptoms of aged people with dementia. The aims of this study are: (1) to determine whether the conditions of cognitive impairment in the treatment groups improve significantly when compared to control; (2) to determine whether other symptoms (e.g., functional independence, pain, depression, and sleep disorder) in the treatment groups improve more than in control; and (3) to investigate whether acupuncture or acupressure is safe for the elderly with cognitive impairment or dementia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
No interventions assigned to this group
CAT group
Subjects assigned to comprehensive acupuncture therapy (CAT) group will receive CAT treatment in addition to routine care.
Comprehensive acupuncture therapy (CAT)
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.
CAE group
Subjects assigned to 'Comfy Acupressure for the Elderly (CAE)' group will receive CAE in addition to routine care.
Comfy Acupressure for the Elderly (CAE)
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.
CAT + CAE group
Subjects assigned to CAT+CAE group will receive CAT+CAE in addition to routine care.
Comprehensive acupuncture therapy (CAT)
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.
Comfy Acupressure for the Elderly (CAE)
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.
Interventions
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Comprehensive acupuncture therapy (CAT)
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.
Comfy Acupressure for the Elderly (CAE)
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.
Eligibility Criteria
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Inclusion Criteria
* have mild to moderate dementia at a stage of 3-5 on the Global Deterioration Scale (GDS).
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Prof. Zhang Zhang-Jin
Professor, Associate Director (Clinical Affairs)
Principal Investigators
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Zhang-Jin Zhang, MMed, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Chinese Medicine, The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Chan CWC, Chau PH, Leung AYM, Lo KC, Shi H, Yum TP, Lee YY, Li L. Acupressure for frail older people in community dwellings-a randomised controlled trial. Age Ageing. 2017 Nov 1;46(6):957-964. doi: 10.1093/ageing/afx050.
Chung KF, Yeung WF, Yu BY, Leung FC, Zhang SP, Zhang ZJ, Ng RM, Yiu GC. Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial. Acupunct Med. 2018 Feb;36(1):2-13. doi: 10.1136/acupmed-2017-011371. Epub 2017 Dec 11.
Hmwe NTT, Browne G, Mollart L, Allanson V, Chan SW. An integrative review of acupressure interventions for older people: A focus on sleep quality, depression, anxiety, and agitation. Int J Geriatr Psychiatry. 2019 Mar;34(3):381-396. doi: 10.1002/gps.5031. Epub 2018 Dec 10.
Kwan RYC, Leung MCP, Lai CKY. A Randomized Controlled Trial Examining the Effect of Acupressure on Agitation and Salivary Cortisol in Nursing Home Residents with Dementia. Dement Geriatr Cogn Disord. 2017;44(1-2):92-104. doi: 10.1159/000478739. Epub 2017 Jul 29.
Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255.
Margenfeld F, Klocke C, Joos S. Manual massage for persons living with dementia: A systematic review and meta-analysis. Int J Nurs Stud. 2019 Aug;96:132-142. doi: 10.1016/j.ijnurstu.2018.12.012. Epub 2019 Jan 4.
Qu SS, Huang Y, Zhang ZJ, Chen JQ, Lin RY, Wang CQ, Li GL, Wong HK, Zhao CH, Pan JY, Guo SC, Zhang YC. A 6-week randomized controlled trial with 4-week follow-up of acupuncture combined with paroxetine in patients with major depressive disorder. J Psychiatr Res. 2013 Jun;47(6):726-32. doi: 10.1016/j.jpsychires.2013.02.004. Epub 2013 Mar 14.
Simoncini M, Gatti A, Quirico PE, Balla S, Capellero B, Obialero R, D'Agostino S, Sandri N, Pernigotti LM. Acupressure in insomnia and other sleep disorders in elderly institutionalized patients suffering from Alzheimer's disease. Aging Clin Exp Res. 2015 Feb;27(1):37-42. doi: 10.1007/s40520-014-0244-9. Epub 2014 May 31.
Toosizadeh N, Lei H, Schwenk M, Sherman SJ, Sternberg E, Mohler J, Najafi B. Does integrative medicine enhance balance in aging adults? Proof of concept for the benefit of electroacupuncture therapy in Parkinson's disease. Gerontology. 2015;61(1):3-14. doi: 10.1159/000363442. Epub 2014 Oct 22.
Wang S, Yang H, Zhang J, Zhang B, Liu T, Gan L, Zheng J. Efficacy and safety assessment of acupuncture and nimodipine to treat mild cognitive impairment after cerebral infarction: a randomized controlled trial. BMC Complement Altern Med. 2016 Sep 13;16(1):361. doi: 10.1186/s12906-016-1337-0.
Wu YT, Ali GC, Guerchet M, Prina AM, Chan KY, Prince M, Brayne C. Prevalence of dementia in mainland China, Hong Kong and Taiwan: an updated systematic review and meta-analysis. Int J Epidemiol. 2018 Jun 1;47(3):709-719. doi: 10.1093/ije/dyy007.
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Yang JW, Shi GX, Zhang S, Tu JF, Wang LQ, Yan CQ, Lin LL, Liu BZ, Wang J, Sun SF, Yang BF, Wu LY, Tan C, Chen S, Zhang ZJ, Fisher M, Liu CZ. Effectiveness of acupuncture for vascular cognitive impairment no dementia: a randomized controlled trial. Clin Rehabil. 2019 Apr;33(4):642-652. doi: 10.1177/0269215518819050. Epub 2019 Jan 23.
Yang MH, Lin LC, Wu SC, Chiu JH, Wang PN, Lin JG. Comparison of the efficacy of aroma-acupressure and aromatherapy for the treatment of dementia-associated agitation. BMC Complement Altern Med. 2015 Mar 29;15:93. doi: 10.1186/s12906-015-0612-9.
Yeung WF, Chung KF, Tso KC, Zhang SP, Zhang ZJ, Ho LM. Electroacupuncture for residual insomnia associated with major depressive disorder: a randomized controlled trial. Sleep. 2011 Jun 1;34(6):807-15. doi: 10.5665/SLEEP.1056.
Yeung WF, Ho FY, Chung KF, Zhang ZJ, Yu BY, Suen LK, Chan LY, Chen HY, Ho LM, Lao LX. Self-administered acupressure for insomnia disorder: a pilot randomized controlled trial. J Sleep Res. 2018 Apr;27(2):220-231. doi: 10.1111/jsr.12597. Epub 2017 Sep 8.
Yue S, Jiang X, Wong T. Effects of a nurse-led acupressure programme for stroke patients in China. J Clin Nurs. 2013 Apr;22(7-8):1182-8. doi: 10.1111/j.1365-2702.2012.04127.x. Epub 2012 Jul 17.
Zhang ZJ, Ng R, Man SC, Li TY, Wong W, Tan QR, Wong HK, Chung KF, Wong MT, Tsang WK, Yip KC, Ziea E, Wong VT. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study. PLoS One. 2012;7(1):e29651. doi: 10.1371/journal.pone.0029651. Epub 2012 Jan 6.
Zhang ZJ, Wang XM, McAlonan GM. Neural acupuncture unit: a new concept for interpreting effects and mechanisms of acupuncture. Evid Based Complement Alternat Med. 2012;2012:429412. doi: 10.1155/2012/429412. Epub 2012 Mar 8.
Other Identifiers
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UW 19-821
Identifier Type: -
Identifier Source: org_study_id
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