Effects of Acupuncture and Intradermal Acupuncture on Insomnia
- Conditions
- Insomnia
- Interventions
- Other: Acupuncture and intradermal acupuncture
- Registration Number
- NCT01956760
- Lead Sponsor
- Kyunghee University
- Brief Summary
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 :
1. Acupuncture group will produce superior effect in the treatment of insomnia compared with control group.
2. Acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 38
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture Acupuncture and intradermal acupuncture 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
- Primary Outcome Measures
Name Time Method Change from Baseline in ISI(Insomnia Severity Index) at 1 week baseline and 1 week
- Secondary Outcome Measures
Name Time Method Change from Auditory ERP at 2 weeks baseline and 2 weeks Follow-up
Change from Heart Rate Variability at 1 week baseline and 1 week Change from Heart Rate Variability at 2 weeks baseline and 2 weeks Follow-up
Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks baseline and 2 weeks Follow-up
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 baseline and 2 weeks Follow-up
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 baseline and 2 weeks Follow-up
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 baseline and 2 weeks Follow-up
Change from Baseline in Sleep Logs at 1 week baseline and 1 week Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency
Change from Baseline in Sleep Logs at 2 week baseline and 2 weeks Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency
Follow-upChange 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 baseline and 2 weeks Follow-up
Change from Digit Span Test at 1 week baseline and 1 week Change from Digit Span Test at 2 weeks baseline and 2 weeks Follow-up
Change from Spectral analysis EEG at 1 week baseline and 1 week Change from Spectral analysis EEG at 2 weeks baseline and 2 weeks Follow-up
Change from Auditory ERP at 1 week baseline and 1 week
Trial Locations
- Locations (1)
HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG
🇰🇷Seoul, Korea, Republic of