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| Name | Class |
|---|---|
| Hong Kong Baptist University | OTHER |
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This is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong.
Combined electro-acupuncture and auricular acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of combined electroacupuncture and auricular acupuncture on persistent insomnia. This is a randomized double-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group, the electro-acupuncture plus auricular acupuncture group or the waitlist controlled group. Patients will be put into groups and then compared.The chance of getting into each group is 3:3:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Active Comparator | Patients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks. |
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| Acupuncture plus auricular acupuncture | Experimental | Subjects will be treated with electroacupuncture plus auricular acupuncture for 3 weeks. The acupuncture regimen, is the same as in electroacupuncture group. In additional to electroacupuncture, subjects will receive auricular acupuncture using borneol. The following 6 ear acupoints points will be selected: Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex. In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours. We will check for skin irritation at each treatment visit. |
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| Waiting-list control | No Intervention | This group will receive no treatment. Subjects will be assessed at baseline and the 4th and 7th week; afterwards, they will be randomized to one of the other two groups in the ratio of 1:1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture plus auricular acupuncture | Procedure | Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks. Aricular acupuncture at Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex.In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of sleep parameters by subjective measures using sleep log | We will measure sleep parameters (including sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. The measure is a composite outcome measure consisting of multiple measures | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of self-rated sleep quality score measured by Insomnia Severity Index (ISI) questionnaire | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment | |
| Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ka-Fai Chung, MBBS | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29567667 | Derived | Chung KF, Yeung WF, Ho FYY, Ng TK. Dysfunctional cognition regarding sleep as a mediator of outcome following acupuncture for insomnia. Acupunct Med. 2018 Jun;36(3):193-194. doi: 10.1136/acupmed-2017-011520. Epub 2018 Mar 22. No abstract available. | |
| 29229613 | Derived | 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. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D020831 | Acupuncture, Ear |
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
| D003131 | Combined Modality Therapy |
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| Acupuncture | Procedure | Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks. |
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| Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS) | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS) | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI) | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS) | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of subjects' sleep-related cognition measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS) | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of subjects' sleep inhibitory behaviors measured by Sleep Hygiene Practice Scale (SHPS) | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of subjects' credibility to the treatment measured by Credibility of treatment rating scale | Second and the last time of the treatment; 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy | Sleep parameters include sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep. The measure is a composite outcome measure consisting of multiple measures | Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of serious adverse events measured by Serious Adverse Event (SAE) | 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| Change of potential adverse events related to acupuncture measured by Adverse Events Report Related to Acupuncture | 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment |
| D001523 |
| Mental Disorders |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |