Effects of Acupuncture and Intradermal Acupuncture on Insomnia

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

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Other: Acupuncture and intradermal acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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
PLACEBO_COMPARATOR: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kyunghee University
• Investigators: Principal Investigator: SUNYONG CHUNG, ph.D, Kyunghee University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): September 1, 2014
• Study Completion (ANTICIPATED): October 1, 2014

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 29, 2013
• First Posted (ESTIMATE): October 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: KHNMC-OH-IRB 2011-015