Acupuncture for Primary Insomnia

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT00839592

Collaborator

Hong Kong Baptist University (Other), Hong Kong Professional Teachers' Union (Other)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Other: Electroacupuncture	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Acupuncture Treatment of Primary Insomnia

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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. Other Names: Acupuncture
Placebo Comparator: 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.	Other: 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. Other Names: Acupuncture

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Other Names:

Acupuncture

Placebo Comparator: 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.

Other: Electroacupuncture

Other Names:

Acupuncture

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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