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Trial registered on ANZCTR


Registration number
ACTRN12617000886381
Ethics application status
Approved
Date submitted
16/05/2017
Date registered
16/06/2017
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture treatment for insomnia
Scientific title
Effect of Individualized Acupuncture Treatment on Insomnia: A Randomized Controlled Trial
Secondary ID [1] 291966 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Insomnia 303312 0
Condition category
Condition code
Alternative and Complementary Medicine 302752 302752 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In clinical practice, acupuncture treatments are individualized according to the TCM pattern diagnosis, also called syndrome differentiation. TCM pattern, in terms of TCM theory, is defined as a diagnostic conclusion of the pathological changes of a disease mainly based on an individual’s symptoms and signs, including pulse form and tongue appearance. The pattern identified determines the appropriate treatment principle, based on which the specific treatment modalities and acupoints stimulated are defined. It is believed from the theoretical view of Chinese medicine that pattern-based TCM treatment will provide better efficacy. For individualized acupuncture treatment, two types of acupoints including basic acupoints and acupoints based on the syndrome differentiation will be selected. Each patient will be evaluated by two licensed Chinese medicine practitioners (CMPs) independently on the same day. The five basic TCM syndrome patterns of insomnia are Fire syndrome caused by stagnation of liver-Qi, Internal disturbance of phlegm-heat, Hyperactivity of fire due to yin deficiency, Deficiency of both the heart and spleen and Deficiency of both heart and gallbladder. Each patient will be classified and assigned to one or two combined patterns from the five TCM patterns. If there is no agreement between the two CMPs on the diagnosis, a senior Chinese medicine practitioner will examine the patient with respect to the dispute.

The basic acupoints are Sishencong (Ex-HN1), Shenmen (HT7), Sanyinjiao (SP6) and Fengchi (GB20). For fire syndrome caused by stagnation of liver-Qi , Taichong (LR3), Xingjian (LR2) and Ganshu (BL 18) may be added. For internal disturbance of phlegm-heat, Zhongwan (CV12), Zusanli (ST36), Fenglong (ST 40) and Neiting (ST 44) may be added. Fro hyperactivity of fire due to Yin deficiency, Xinshu (BL 15), Shenshu (BL 23), Taixi (KI 3) and Ximen (PC 4) may be added. For deficiency of both heart and spleen, Xinshu (BL 15), Pishu (BL20) and Jueyinshu (BL 14) may be added. For deficiency of both heart and gallbladder, Xinshu (BL 15), Danshu (BL 19) and Qiuxu (GB 40) may be added. For subjects assigned to one TCM pattern, two to four acupoints with regard to the corresponding pattern will be selected. For subjects assigned to two combined TCM patterns, two to four acupoints of the two corresponding patterns will be selected.

The subjects will be treated 2 times per week for 4 weeks. Each treatment will last 30 minutes. Acupuncture interventions are carried out by licensed Chinese medicine practitioners with at least 2 years’ clinical experience. The same patient is treated by the same Chinese medicine practitioner throughout the study. Both groups will use the same kinds of disposable, sterile steel needles (MOCM, 0.25 X 25mm and 0.25 X 40mm) and same skin disinfection process with alcohol pads in the treatment.

All researchers, practitioners and assessors will undergo training before participating in this study to ensure consistent practices and strict adherence to the study protocol. The training will include diagnoses, inclusion and exclusion criteria, screening and outcome measuring. Acupuncturists will be trained in the location of acupoints and acupuncture manipulation techniques. And the work manual will be provided for different parties. The treatment will be administered in the Christian Family Service Centre - The CUHK Chinsese Medicine Centre for Training & Research (Ngau Tau Kok).

Dropouts and withdrawals from the study will be documented. Periodic monitoring will guarantee accuracy and quality throughout the study.
Intervention code [1] 298094 0
Treatment: Other
Comparator / control treatment
Standardized acupuncture treatment is applied on the following acupoints: Baihui (GV20), Sishencong (Ex-HN1), Yintang (EX-HN3), Anmian (EX) and bilateral Ear Shenmen. A total of 8 acupuncture treatment sessions (2 times per week) will be administered.
Control group
Active

Outcomes
Primary outcome [1] 302142 0
Insomnia Severity Index (ISI)
Timepoint [1] 302142 0
1-week post-treatment (week 5) and 4-week post treatment (week 8)
Secondary outcome [1] 334934 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 334934 0
1-week post-treatment (week 5) and 4-week post treatment (week 8)
Secondary outcome [2] 335727 0
One-week Sleep diary
Timepoint [2] 335727 0
1-week post-treatment (week 5) and 4-week post treatment (week 8)

Eligibility
Key inclusion criteria
All eligible subjects should be Chinese adult aged 18 or above who report having insomnia 3 or more nights per week for a minimum of three months, whose symptoms meet the criteria of the revised Hong Kong Chinese version of Brief Insomnia Questionnaire (HK-BIQ). HK-BIQ is a lay-administered, structured interview covering the diagnostic criteria of insomnia disorders according to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Has a severe neural or psychiatric disorder; b. Substance use insomnia disorder besides caffeine or nicotine use; c. Has taken western and/or herbal medicine in the past 2 weeks for insomnia; d. Has taken anti-coagulant or anti-platelet drugs in the past one month; e. Has received acupuncture for insomnia treatment in the past one month; f. Has participated in any other clinical trial within a month of the screening date; g. Has contradictions of acupuncture, e.g. hemorrhagic disease, infection or inflammation at the acupoints, pregnancy or being a woman of childbearing age not on a proper method of birth control, cancer patients etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8906 0
Hong Kong
State/province [1] 8906 0

Funding & Sponsors
Funding source category [1] 296477 0
Government body
Name [1] 296477 0
Chinese Medicine Department, Hong Kong Hospital Authority
Address [1] 296477 0
Block C, Hong Kong Buddhist Hospital, 10 Heng Lam Street, Lok Fu, Kowloon, Hong Kong
Country [1] 296477 0
Hong Kong
Primary sponsor type
University
Name
School of Chinese Medicine, The Chinese University of Hong KOng
Address
1F, Sino building, Shatin, N.T. Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 295434 0
Other Collaborative groups
Name [1] 295434 0
Christian Family Service Centre - The Chinese University of Hong Kong Chinese Medicine Centre for Training and Research (Ngau Tau Kok)
Address [1] 295434 0
B, G/F., 3 Tsui Ping Road; Kowloon, Hong Kong.
Country [1] 295434 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297699 0
The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC)
Ethics committee address [1] 297699 0
Joint CUHK-NTEC Clinical Research Ethics Committee
8/F, Lui Che Woo Clinical Sciences Building,
Prince of Wales Hospital
Shatin, Hong Kong
Ethics committee country [1] 297699 0
Hong Kong
Date submitted for ethics approval [1] 297699 0
Approval date [1] 297699 0
24/11/2016
Ethics approval number [1] 297699 0

Summary
Brief summary
Background: Many clinical trials have been performed to study the efficacy of acupuncture for insomnia. The results have shown that the acupuncture might be overall a promising treatment modality for insomnia. However, majority of the studies were of low methodological quality. In clinical practice, acupuncture treatments are individualized according to the Traditional Chinese Medicine (TCM) pattern diagnosis. It is believed from the theoretical view of Chinese medicine that pattern-based TCM treatment will provide better efficacy. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individual differences, and as a result, have not been reflective of the true efficacy of clinical practice. Previous clinical studies regarding the efficacy of syndrome differentiation-based acupuncture treatment is rare.

Objective: To compare the effectiveness of individualized acupuncture based on TCM syndrome differentiation with standardized acupuncture in patients with insomnia.

Design: Pilot, parallel, double blinded, randomized controlled trial

Setting: Subjects will be recruited from the Christian Family Service Centre - The CUHK Chinsese Medicine Centre for Training & Research (Ngau Tau Kok) via referrals from Chinese Medicine Practitioners and advertisement or poster at the clinic and electronic media.

Participants: 40 subjects aged 18 or above who report having insomnia 3 or more nights per week for a minimum of three months.

Inclusion criteria: Chinese adult aged 18 or above who report having insomnia 3 or more nights per week for a minimum of three months, whose symptoms meet the criteria of the revised Hong Kong Chinese version of Brief Insomnia Questionnaire (HK-BIQ) which covers the diagnostic criteria of insomnia disorders according to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5).

Interventions: All eligible subjects will be randomly allocated into individualized acupuncture group or standardized acupuncture group in a ratio 1:1. All patients receive CM diagnosis before the first treatment. Each patient will be evaluated by two licensed Chinese medicine practitioners (CMPs) independently on the same day. The individualized acupuncture or standardized acupuncture treatment will be administered 2 times per week for 4 weeks.

Outcome measures: The primary outcome is Insomnia Severity Index (ISI), and the secondary outcomes include Hospital Anxiety and Depression Scale (HADS), and One-week Expanded Consensus Sleep Diary for Morning (CSD-M). Assessments will be made at baseline, 1-week post-treatment (week5) and 4-week post treatment (week 8).

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74870 0
Dr ZHANG Hongwei
Address 74870 0
1F, Sino building, School of Chinese Medicine, CUHK, Shatin, N.T., Hong Kong.
Country 74870 0
Hong Kong
Phone 74870 0
+852-39439845
Fax 74870 0
+852-39420941
Email 74870 0
zhanghw@cuhk.edu.hk
Contact person for public queries
Name 74871 0
Ms Cheng Tsz Ha
Address 74871 0
Christian Family Service Centre - The Chinese University of Hong Kong Chinese Medicine Centre for Training and Research (Ngau Tau Kok);
B, G/F., 3 Tsui Ping Road;
Country 74871 0
Hong Kong
Phone 74871 0
+852-2950 8105
Fax 74871 0
Email 74871 0
th_cheng@cfsc.org.hk
Contact person for scientific queries
Name 74872 0
Dr ZHANG Hongwei
Address 74872 0
1F, Sino building, School of Chinese Medicine, CUHK, Shatin, N.T., Hong Kong.
Country 74872 0
Hong Kong
Phone 74872 0
+852-39439845
Fax 74872 0
+852-39420941
Email 74872 0
zhanghw@cuhk.edu.hk

No data has been provided for results reporting
Summary results
Not applicable