Acupuncture for Primary Insomnia

NCT ID: NCT00839592

Last Updated: 2010-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-04-30

Brief Summary

This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the adult population in Hong Kong.

Detailed Description

Acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on primary insomnia. This is a randomized single-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group or the placebo acupuncture group. Patients will be put into groups and then compared.

Conditions

Insomnia

Study Design

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

Study Groups

Electroacupuncture

Acupoints will be treated at bilateral Ear Shenmen, Sishencong (EX-HN1), Anmian, and unilateral Yintang (EX-HN3) and Baihui (GV20).

Acupuncture will be performed by a registered Chinese medicine practitioner. "De qi"(an irradiating feeling considered to be indicative of effective needling) is achieved if possible. An electric-stimulator (CEFAR Acus II, Lund, Sweden) will be connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.45 ms square wave pulses and constant current. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: OTHER

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Placebo Acupuncture

Placebo needles designed by Streitberger (1998) will be used. The placebo needles are blunt needle that will not penetrate the skin during needle insertion. The handles of these placebo needles will slide over the needle when it is compressed, giving it the appearance of penetrating the skin. The placebo needles are inserted to the same acupoints as stated in the electroacupuncture group. The needles are held by a surgical tape or hair pin in hairy region to imitate the retention of needles. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of the treatment sessions, and the intervention procedure will be the same for electro-acupuncture and placebo acupuncture.

Group Type: PLACEBO_COMPARATOR

Electroacupuncture

Intervention Type: OTHER

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Interventions

Electroacupuncture

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Intervention Type: OTHER

Other Intervention Names

Acupuncture

Eligibility Criteria

Inclusion Criteria

• Hong Kong residents
• aged 18-65
• Ethnic Chinese
• Meet the diagnosis criteria of primary insomnia for at least 3 months according to DSM-IV using the Structured Clinical Interview for DSM-IV (SCID)
• Willing to give informed consent
• total score of Insomnia Severity Index (ISI) at least 15
• Able to comply with trial protocol

Exclusion Criteria

• Participation in any clinical trial during the previous 3 months prior to baseline
• Any current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders besides caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder as defined by DSM-IV criteria
• Serious physical illness or mental disorders due to a general medical condition which is judged by the investigator to render unsafe
• Valvular heart defects, bleeding disorders or taking anticoagulant drugs.
• Any acupuncture treatment during the previous 12 months prior to baseline.
• In the investigator's opinion, the patient has a significant risk of suicide
• Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
• Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
• Herbal remedies, over-the-counter medications or psychotropic drugs, which are intended for insomnia, were taken within the last 2 weeks prior to baseline or during the study

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

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: collaborator

Hong Kong Professional Teachers' Union

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

the University of Hong Kong

Principal Investigators

Ka-Fai Chung, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Yeung WF, Chung KF, Yu YB, Lao L. What predicts a positive response to acupuncture? A secondary analysis of three randomised controlled trials of insomnia. Acupunct Med. 2017 Mar;35(1):24-29. doi: 10.1136/acupmed-2016-011058. Epub 2016 Aug 8.

Reference Type: DERIVED

PMID: 27503746 (View on PubMed)

Yeung WF, Chung KF, Zhang SP, Yap TG, Law AC. Electroacupuncture for primary insomnia: a randomized controlled trial. Sleep. 2009 Aug;32(8):1039-47. doi: 10.1093/sleep/32.8.1039.

Reference Type: DERIVED

PMID: 19725255 (View on PubMed)

Other Identifiers

ACUP-001

Identifier Type: -

Identifier Source: org_study_id