Effects of Acupuncture and Intradermal Acupuncture on Insomnia

Study Overview
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Brief Summary
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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 : Acupuncture group will produce superior effect in the treatment of insomnia compared with control group. Acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.

Detailed Description
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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.

Official Title
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A Randomized Controlled Clinical Trial to Evaluate Effectiveness of Acupuncture on Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Other: Acupuncture and intradermal acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between the age of 18years and 65 years. Diagnosed as having Insomnia using Pittsburgh Sleep Quality Index(PSQI score>5). Have no problems with communication (for example, reading, writing, listening, speaking). Provided written informed consent. Exclusion Criteria: Regular medication, Herbal medication or health functional food for treating insomnia Presence of major neuropsychiatric disorder (for example, mental retardation, psychosis and severe mood disorder) Presence of inflammatory skin disease on the acupuncture site Presence of bleeding disorders or takes anticoagulant Presence of severe physical diseases that may preclude the safe use of acupuncture Enrolled in another clinical study in the past 1 month Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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 | Other: Acupuncture and intradermal acupuncture<br>* 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<br>|
| Placebo Comparator: Placebo Acupuncture<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in ISI(Insomnia Severity Index) at 1 week |  | baseline and 1 week | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia