Effects of Acupuncture and Intradermal Acupuncture on Insomnia

NCT01956760 | Unknown DMC

• 1 other identifier: KHNMC-OH-IRB 2011-015
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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. 1.Acupuncture group will produce superior effect in the treatment of insomnia compared with control group.
2. 2.Acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.

Conditions

Insomnia

Keywords

Insomnia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in ISI(Insomnia Severity Index) at 1 week

  baseline and 1 week

Secondary Outcomes (20)

• Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks

  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

  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

  baseline and 2 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Placebo Acupuncture

PLACEBO COMPARATOR

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

Interventions

Acupuncture and intradermal acupuncture 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

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University: lead

Study Sites (1)

HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25342100 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• SUNYONG CHUNG, ph.D

  Kyunghee University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

KR (1)