Acupuncture for Primary Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Other: Electroacupuncture

• Registration Number: NCT00839592
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	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.
Placebo Acupuncture	Electroacupuncture	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.

Primary Outcome Measures

Name	Time	Method
Self-rated sleep quality score measured by Insomnia Severity Index questionnaire	Baseline, weekly during the treatment course, 1-week posttreatment

Secondary Outcome Measures

Name	Time	Method
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by objective measure - wrist actigraphy	Baseline, and 1-week posttreatment
Sleep parameters (sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log.	Baseline, weekly during the treatment course, and 1-week posttreatment
Self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire	Baseline, and 1-week posttreatment
Anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)	Baseline, and 1-week posttreatment
Subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Index	Baseline, and 1-week posttreatment
Subjects' credibility to the treatment measured by Credibility of treatment rating scale	Second and the last time of the treatment

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong