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Effects of Acupuncture and Intradermal Acupuncture on Insomnia

Primary Purpose

Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture and intradermal acupuncture
Sponsored by
Kyunghee University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture

Placebo Acupuncture

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks
Follow-up
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 1 week
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 2 weeks
Follow-up
Change from Baseline in BDI(Beck Depression Inventory) at 1 week
Change from Baseline in BDI(Beck Depression Inventory) at 2 weeks
Follow-up
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 1 week
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 2 weeks
Follow-up
Change from Baseline in Sleep Logs at 1 week
Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency
Change from Baseline in Sleep Logs at 2 week
Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency Follow-up
Change from Baseline in WHOQOL-Bref at 2 weeks
Change from Auditory Verbal Learning Test at 1 week
Change from Baseline in Auditory Verbal Learning Test at 2 weeks
Follow-up
Change from Digit Span Test at 1 week
Change from Digit Span Test at 2 weeks
Follow-up
Change from Spectral analysis EEG at 1 week
Change from Spectral analysis EEG at 2 weeks
Follow-up
Change from Auditory ERP at 1 week
Change from Auditory ERP at 2 weeks
Follow-up
Change from Heart Rate Variability at 1 week
Change from Heart Rate Variability at 2 weeks
Follow-up

Full Information

First Posted
September 5, 2013
Last Updated
January 9, 2014
Sponsor
Kyunghee University
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1. Study Identification

Unique Protocol Identification Number
NCT01956760
Brief Title
Effects of Acupuncture and Intradermal Acupuncture on Insomnia
Official Title
A Randomized Controlled Clinical Trial to Evaluate Effectiveness of Acupuncture on Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 : Acupuncture group will produce superior effect in the treatment of insomnia compared with control group. Acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.
Detailed Description
The acupuncture group is received acupuncture and intradermal acupuncture therapy at 5 acupoints on wrist and ankle. The control group is received same treatment at 5 sham points approximately 1cm lateral to the acupoints. Except for the location of acupuncture points, all details of treatment are same between acupuncture group and control group. A certified practitioner treat both groups 3 times in a week. The acupuncture inserted into the skin for 20 minutes and the intradermal acupuncture inserted and fixed on the same points for 48~72 hours. Severity of insomnia, anxiety, depression, quality of life, recognition, attention, and memory are assessed at the baseline, after the last treatment and at a week after the end of last treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Acupuncture
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Acupuncture and intradermal acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline in ISI(Insomnia Severity Index) at 1 week
Time Frame
baseline and 1 week
Secondary Outcome Measure Information:
Title
Change from Baseline in ISI(Insomnia Severity Index) at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 1 week
Time Frame
baseline and 1 week
Title
Change from Baseline in STAI(State-Trait Anxiety Inventory) at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Baseline in BDI(Beck Depression Inventory) at 1 week
Time Frame
baseline and 1 week
Title
Change from Baseline in BDI(Beck Depression Inventory) at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 1 week
Time Frame
baseline and 1 week
Title
Change from Baseline in PSQI(Pittsburgh Sleep Quality Index) at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Baseline in Sleep Logs at 1 week
Description
Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency
Time Frame
baseline and 1 week
Title
Change from Baseline in Sleep Logs at 2 week
Description
Sleep onset latency, Total sleep time, Wake time after sleep onset and Sleep efficiency Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Baseline in WHOQOL-Bref at 2 weeks
Time Frame
baseline and 2 weeks
Title
Change from Auditory Verbal Learning Test at 1 week
Time Frame
baseline and 1 week
Title
Change from Baseline in Auditory Verbal Learning Test at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Digit Span Test at 1 week
Time Frame
baseline and 1 week
Title
Change from Digit Span Test at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Spectral analysis EEG at 1 week
Time Frame
baseline and 1 week
Title
Change from Spectral analysis EEG at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Auditory ERP at 1 week
Time Frame
baseline and 1 week
Title
Change from Auditory ERP at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks
Title
Change from Heart Rate Variability at 1 week
Time Frame
baseline and 1 week
Title
Change from Heart Rate Variability at 2 weeks
Description
Follow-up
Time Frame
baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SUNYONG CHUNG, ph.D
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
HYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25342100
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Acupuncture and Intradermal Acupuncture on Insomnia

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