A study of acupuncturing “Chou’s Tiaoshen” acupoints on patients in subacute insomnia

ISRCTN ISRCTN24323119
DOI https://doi.org/10.1186/ISRCTN24323119
Secondary identifying numbers N/A
Submission date
01/12/2017
Registration date
13/12/2017
Last edited
26/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Insomnia is a common sleeping problem. Insomnia makes it hard to initiate or maintainsleep or nonrestorative sleep. Sleep disturbance causes distress or damage in social, occupational, or other important areas of functioning. As an alternative therapeutic method, acupuncture offers another option for insomnia. Acupuncture is a treatment that inserts fine needles at certain areas in the body to be therapeutic. It is based on the theory of meridians of Traditional Chinese Medicine (TCM). Meridian is considered to be a network of passages of the energy power, Qi. According to ancient TCM classic of Nei Jing (Inner Classic), insomnia is a consequence of the vicious cycle of “daytime low-spirit” and “nighttime hyperarousal state.” Acupuncture is considered to be beneficial to restore the normal sleep-wake cycle by regulating and restoring the natural flow of Qi. The aim of this study is to explore the effect of using acupuncture (and using specific Chou’s Tiaoshen acupoints) to help patients with insomnia.

Who can participate?
Adults aged 20-60 years old who have sleep difficulties at least three nights per week.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive acupuncture using the “Chou’s Tiaoshen” acupoints five times a week for two weeks. Those in the second group take estazolam 30 minutes prior to bedtime for two weeks. Participants are followed up to examine the quality of their sleep and their insomnia symptoms using sleep diaries and questionnaires before and after the treatment.

What are the possible benefits and risks of participating?
It is expected that participants will experience lower frequency and severity of subacute insomnia as well as improved sleep quality, thus improving life quality of patients and alleviating side effects of taking drugs and operations. Furthermore, data and evidence gained from this study will be helpful in the future research projects. The risks of taking part are minimal. Acupuncture is a very safe treatment when given by properly trained clinicians. Occasionally acupuncture can make people feel nauseous or faint or experience a temporary increase in pain either during or after treatment. Participants are warned of these potential side-effects before consenting to have acupuncture.

Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)

When is the study starting and how long is it expected to run for?
June 2017 to December 2018

Who is funding the study?
Beijing Municipal Administration of Hospitals (China)

Who is the main contact?
Dr Huanqin Li

Contact information

Ms Huanqin Li
Scientific

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Backstreet Gallery No. 23
Dongcheng District
Beijing
100010
China

Miss Tuo Tuo
Public

Beijing University of Chinese Medicine
North Third Ring Road NO.11
Chaoyang District
Beijing
100029
China

Phone +86 18001104650
Email tuotuo1123@icloud.com

Study information

Study designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleObservation on clinical efficacy of acupuncturing “Chou’s Tiaoshen” acupoints on patients in subacute insomnia
Study objectivesCompared with taking estazolam, acupuncturing “Chou’s Tiaoshen” acupoints can improve patients’ sleeping quality in subacute insomnia equally or better.
Ethics approval(s)Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, 18/07/2017, ref:2017BL-055-01.
Health condition(s) or problem(s) studiedSubacute insomnia
InterventionParticipants are randomly allocated to one of two groups.

Treatment group: Participants receive acupuncture using "Chou’s Tiaoshen” acupoints, including Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1), Sanyinjiao (SP-6), Shenmen (HT-7) . Using stainless steel needles (0.32×40 mm, HuaTuo, China). Then some other points like, Danzhong(CV-17), Taixi (KI-3), Qihai (CV-6), Taichong (LR3), and Qiuxu(GB-40) are chosen. Operation: Patients in supine position. Baihui (GV-20), Shenting (GV-24), and Sishencong (EX-HN1) are punctured at a depth of 20-25mm obliquely. Sanyinjiao (SP-6) and Shenmen (HT-7) are inserted 15mm perpendicularly. Until feeling tactile sensation then manually manipulated by rotation methods to produce a characteristic sensation known as "De Qi".

Mild reinforcing and attenuating, retaining the needle for 30minutes. When all the needles inserted, needle handles needs to be a line horizontally and vertically. The treatment will be given once a day and 5 times a week in weekdays, the course will last two weeks.

Control group: Participants take estazolam 30min prior to bedtime in the day. The course will last two weeks.

Participants keep sleep diaries and are followed up with questionnaires to examine thier symptoms of insomnia and sleep quality.
Intervention typeOther
Primary outcome measureSleep quality and disturbances are measured using the Pittsburgh sleep quality index (PSQI) at baseline, day 14 and day 28.
Secondary outcome measures1. Insomnia severity level are measured using insomnia severity index (ISI) at baseline, day 14 and day 28
2. Daytime function or daytime fatigue is measured using Fatigue Scale (FS)(FS incluing the items of physical fatigue and mental fatigue) at baseline, day 14 and day 28
3. Symptoms of insomnia are measured using Sleep diaries. It will be recorded everyday after patients start to be treated, and we will take their Sleep diaries at day 14 and day 28
Overall study start date01/06/2017
Completion date30/03/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants96
Key inclusion criteria1. According to the Diagnostic and Statistical Manual of Mental Disorders Text Revision, 5th ed (DSM-V) and Chinese Adult Insomnia Diagnosis and Treatment Guide 2012
2. A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
2.1. Difficulty initiating sleep
2.2. Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings
2.3. Early-morning awakening with inability to return to sleep
3. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning
4. The sleep difficulty occurs at least 3 nights per week. The sleep difficulty is present for at least 1 months
5. Experienced insomnia between 4 weeks and 3 months before the start of project
6. Age: patients between 20 and 60 years old
7. Not yet taken estazolam for more than 3 days
8. Patients who agreed to participant in this trial and assigned the informed consent
Key exclusion criteria1. Having depression, anxiety or schizophrenia
2. Patients with serious heart, liver, kidney and hematopoietic system diseases or mental disorders
3. Patients who could not cooperate with the investigators
4. Insomnia course less than 4 weeks
5.Taken anti-anxiety depression drugs or assisted sleeping medication in the past 6 months
Date of first enrolment20/01/2018
Date of final enrolment31/12/2018

Locations

Countries of recruitment

  • China

Study participating centre

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Backstreet Gallery No. 23 in Dongcheng District
Beijing
100010
China

Sponsor information

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Hospital/treatment centre

Backstreet Gallery No. 23
Dongcheng District
Beijing
100010
China

Phone +86 10 52176813
Email bjzykyc@163.com
ROR logo "ROR" https://ror.org/057vq6e26

Funders

Funder type

Government

Beijing Municipal Administration of Hospitals

No information available

Results and Publications

Intention to publish date01/08/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe plan to publish a protocol of this trial in about 6-8 months after the registration, and one paper of the trial including results in a high-impact peer reviewed journal in one year after the trial.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Ms Huanqin Li (hqin_li@163.com).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 26/03/2020 26/03/2020 No No

Additional files

ISRCTN24323119_BasicResults_26March20.pdf
Uploaded 26/03/2020

Editorial Notes

26/0/2020: The basic results of this trial have been uploaded as an additional file.
22/11/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2018 to 31/12/2018.
2. The overall trial end date was changed from 31/12/2018 to 30/03/2019.