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The aim of this clinical study is to observe the therapeutic effect of acupuncture and intradermal acupuncture in the treatment of insomnia
Participants were randomized into the acupuncture group and control group. Both groups were treated 3 times in a week and assessed before and after the treatment.
Hypothesis :
The acupuncture group is received acupuncture and intradermal acupuncture therapy at 5 acupoints on wrist and ankle. The control group is received same treatment at 5 sham points approximately 1cm lateral to the acupoints.
Except for the location of acupuncture points, all details of treatment are same between acupuncture group and control group. A certified practitioner treat both groups 3 times in a week. The acupuncture inserted into the skin for 20 minutes and the intradermal acupuncture inserted and fixed on the same points for 48~72 hours.
Severity of insomnia, anxiety, depression, quality of life, recognition, attention, and memory are assessed at the baseline, after the last treatment and at a week after the end of last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Acupuncture and intradermal acupuncture The acupuncture was applied at 5 acupoints(HT7 Shenmen, PC6 Neiguan, SP6 Sanyinjiao, KI6 Zhaohai, BL62 Shenmai) 3 times in a week. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same acupoints, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours |
|
| Placebo Acupuncture | Placebo Comparator | Placebo acupuncture and placebo intradermal acupuncture The acupuncture was applied 3 times in a week at 2 sham points on the wrist and 3 sham points on the ankle, approximately 1cm lateral to the acupoints. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same sham points, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and intradermal acupuncture | Other | The acupuncture was applied at 5 acupoints(HT7 Shenmen, PC6 Neiguan, SP6 Sanyinjiao, KI6 Zhaohai, BL62 Shenmai) 3 times in a week. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same acupoints, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in ISI(Insomnia Severity Index) at 1 week | baseline and 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Baseline in STAI(State-Trait Anxiety Inventory) at 1 week | baseline and 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SUNYONG CHUNG, ph.D | Kyunghee University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25342100 | Derived | Han KH, Kim SY, Chung SY. Effect of acupuncture on patients with insomnia: study protocol for a randomized controlled trial. Trials. 2014 Oct 23;15:403. doi: 10.1186/1745-6215-15-403. |
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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 |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Change from Baseline in STAI(State-Trait Anxiety Inventory) at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Baseline in BDI(Beck Depression Inventory) at 1 week | baseline and 1 week |
| Change from Baseline in BDI(Beck Depression Inventory) at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 1 week | baseline and 1 week |
| Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Baseline in Sleep Logs at 1 week | Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency | baseline and 1 week |
| Change from Baseline in Sleep Logs at 2 week | Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency Follow-up | baseline and 2 weeks |
| Change from Baseline in WHOQOL-Bref at 2 weeks | baseline and 2 weeks |
| Change from Auditory Verbal Learning Test at 1 week | baseline and 1 week |
| Change from Baseline in Auditory Verbal Learning Test at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Digit Span Test at 1 week | baseline and 1 week |
| Change from Digit Span Test at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Spectral analysis EEG at 1 week | baseline and 1 week |
| Change from Spectral analysis EEG at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Auditory ERP at 1 week | baseline and 1 week |
| Change from Auditory ERP at 2 weeks | Follow-up | baseline and 2 weeks |
| Change from Heart Rate Variability at 1 week | baseline and 1 week |
| Change from Heart Rate Variability at 2 weeks | Follow-up | baseline and 2 weeks |
| D001523 |
| Mental Disorders |