Effects of Acupuncture and Intradermal Acupuncture on Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01956760
• Other study ID #: KHNMC-OH-IRB 2011-015
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 5, 2013
• Last updated: January 9, 2014
• Start date: September 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2014
• Source: Kyunghee University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Other:
• 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

Locations

Country	Name	City	State
Korea, Republic of	HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in ISI(Insomnia Severity Index) at 1 week		baseline and 1 week	No
Secondary	Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	Change from Baseline in STAI(State-Trait Anxiety Inventory) at 1 week		baseline and 1 week	No
Secondary	Change from Baseline in STAI(State-Trait Anxiety Inventory) at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	Change from Baseline in BDI(Beck Depression Inventory) at 1 week		baseline and 1 week	No
Secondary	Change from Baseline in BDI(Beck Depression Inventory) at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 1 week		baseline and 1 week	No
Secondary	Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Change from Baseline in WHOQOL-Bref at 2 weeks		baseline and 2 weeks	No
Secondary	Change from Auditory Verbal Learning Test at 1 week		baseline and 1 week	No
Secondary	Change from Baseline in Auditory Verbal Learning Test at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	Change from Digit Span Test at 1 week		baseline and 1 week	No
Secondary	Change from Digit Span Test at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	Change from Spectral analysis EEG at 1 week		baseline and 1 week	No
Secondary	Change from Spectral analysis EEG at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	Change from Auditory ERP at 1 week		baseline and 1 week	No
Secondary	Change from Auditory ERP at 2 weeks	Follow-up	baseline and 2 weeks	No
Secondary	Change from Heart Rate Variability at 1 week		baseline and 1 week	No
Secondary	Change from Heart Rate Variability at 2 weeks	Follow-up	baseline and 2 weeks	No