Effects of Acupuncture and Intradermal Acupuncture on Insomnia

NCT ID: NCT01956760

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-10-31

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Acupuncture and intradermal acupuncture

Intervention Type: 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

Placebo Acupuncture

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyunghee University

OTHER

Sponsor Role: lead

Responsible Party

Sun Yong Chung

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SUNYONG CHUNG, ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University

Locations

HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 25342100 (View on PubMed)

Other Identifiers

KHNMC-OH-IRB 2011-015

Identifier Type: -

Identifier Source: org_study_id