Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

NCT01891097 | Completed

• 1 other identifier: ACUP-005
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong.

Conditions

Insomnia

Keywords

Insomnia; Acupuncture; Electroacupuncture; Aricular acupuncture; Randomized Clinical Trial; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Changes of sleep parameters by subjective measures using sleep log

  We will measure sleep parameters (including sleep onset latency, sleep efficiency, total sleep time, times of wakening during sleep) by subjective measures using sleep log. The measure is a composite outcome measure consisting of multiple measures

  Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

Secondary Outcomes (12)

• Change of self-rated sleep quality score measured by Insomnia Severity Index (ISI) questionnaire

  Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

• Change of self-rated sleep quality score measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire

  Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

• Change of anxiety and depression states measured by Hospital Anxiety and Depression Scale (HADS)

  Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

• Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)

  Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

• Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)

  Baseline, 1-week posttreatment, 4-week posttreatment, and 13-week posttreatment

Study Arms (3)

Acupuncture

ACTIVE COMPARATOR

Patients will be treated at bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, Neiguan PC6, Shenmen HT7, Sanyinjiao SP6, and unilateral Yintang EX-HN3 and Baihui GV20. Acupuncture treatment 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 (ITO ES160, Japan) is connected to these needles to give an electric-stimulation in continuous wave, frequency of 4 Hz, 0.4 ms square wave pulses and constant current. Surgical tape or hair pin will be adhered to the needles.The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.

Procedure: Acupuncture

Acupuncture plus auricular acupuncture

EXPERIMENTAL

Subjects will be treated with electroacupuncture plus auricular acupuncture for 3 weeks. The acupuncture regimen, is the same as in electroacupuncture group. In additional to electroacupuncture, subjects will receive auricular acupuncture using borneol. The following 6 ear acupoints points will be selected: Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex. In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours. We will check for skin irritation at each treatment visit.

Procedure: Acupuncture plus auricular acupuncture

Waiting-list control

NO INTERVENTION

This group will receive no treatment. Subjects will be assessed at baseline and the 4th and 7th week; afterwards, they will be randomized to one of the other two groups in the ratio of 1:1.

Interventions

Acupuncture plus auricular acupuncture PROCEDURE

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , 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. Aricular acupuncture at Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex.In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours.

Also known as: Acupuncture, Electroacupuncture

Acupuncture plus auricular acupuncture

Acupuncture PROCEDURE

Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , 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.

Also known as: Electroacupuncture

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or above
• Hong Kong residents
• Ethnic Chinese
• Meet the diagnosis criteria of presistent insomnia for at least 3 months according to Current Diagnostic and Statistical Manual of Mental Disorders (the proposed Fifth Edition)
• Insomnia more than 3 nights per week for at least 3 months
• Willing to give informed consent
• Able to comply with trial protocol

You may not qualify if:

• Have a Hamilton Depression Rating Scale scores above 18
• Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
• Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
• Have current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders except caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder
• Receiving psychotropic drugs with dosage changes in the last 4 weeks prior to screening, baseline or during the study
• Have valvular heart defects or bleeding disorders or were taking anticoagulant drugs
• Are pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
• Have any unstable psychiatric conditions or serious physical illnesses which are judged by the investigator to render unsuitable or unsafe
• Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
• Any acupuncture or auricular acupuncture treatment during the previous 6 months prior to baseline

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hong Kong Baptist University: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

• Chung KF, Yeung WF, Ho FYY, Ng TK. Dysfunctional cognition regarding sleep as a mediator of outcome following acupuncture for insomnia. Acupunct Med. 2018 Jun;36(3):193-194. doi: 10.1136/acupmed-2017-011520. Epub 2018 Mar 22. No abstract available.

  PMID: 29567667 DERIVED

• Chung KF, Yeung WF, Yu BY, Leung FC, Zhang SP, Zhang ZJ, Ng RM, Yiu GC. Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial. Acupunct Med. 2018 Feb;36(1):2-13. doi: 10.1136/acupmed-2017-011371. Epub 2017 Dec 11.

  PMID: 29229613 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy; Acupuncture, Ear; Electroacupuncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Auriculotherapy; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Ka-Fai Chung, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: July 2, 2013
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)