Laser Meridian Massage in Heroin Addicts
Primary Purpose
Heroin Dependence
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
laser meridian massage
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence focused on measuring Laser meridian massage, heroin addicts, methadone treatment, traditional Chinese medicine
Eligibility Criteria
Inclusion Criteria:
- Provide informed consent
- Male older than 20 years
- Diagnosed with opioid use disorder according to DSM-5 and received methadone treatment more than 1 month
Exclusion Criteria:
- Received Antidepressant or antipsychotic
- Received Chinese herb or acupuncture treatment during last 30 days
- Critical illness
- Did not meet the physician's assessment for recruitment
- Patients with Human immunodeficiency virus infection
- Did not provide informed consent
Sites / Locations
- Kaohsiung Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Laser meridian massage
Control
Arm Description
They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks.
A control group of participants without laser meridian massage treatment are matched by age.
Outcomes
Primary Outcome Measures
Heroin use
Times or days of heroin use during last week
Heroin use
Times or days of heroin use during last week
Urine morphine
Obtainurinary morphine concentration
Urine morphine
Obtain urinary morphine concentration
Secondary Outcome Measures
Heroin craving / refusal of heroin use
Obtain Visual Analogue Scales (VAS) of heroin craving / refusal of heroin use (0-10 points) during last week. VAS score 0 of heroin craving indicates no heroin craving, while VAS 10 indicates strongest heroin craving. VAS 0 of refusal of heroin use indicates no refusal of heroin, while VAS 10 indicates absolute refusal of heroin.
Heroin craving / refusal of heroin use
Obtain Visual Analogue Scales (VAS) of heroin craving / refusal of heroin use (0-10 points) during last week. VAS score 0 of heroin craving indicates no heroin craving, while VAS 10 indicates strongest heroin craving. VAS 0 of refusal of heroin use indicates no refusal of heroin, while VAS 10 indicates absolute refusal of heroin.
Short Form-12v2 Health Survey
The SF-12v2® Health Survey (SF-12v2) is a multipurpose, short-form health survey with 12 questions that yields an eight-scale profile of functional health and well-being, as well as two psychometrically based physical and mental health summary measures and a preference-based health utility index.
The PRO CoRE, part of the Smart Measurement® System suite of products and Optum's upgrade to the QualityMetric Health Outcomes™ Scoring Software, is used for scoring the SF-12v2® Health Survey.
Full Information
NCT ID
NCT04003077
First Posted
June 18, 2019
Last Updated
March 13, 2020
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04003077
Brief Title
Laser Meridian Massage in Heroin Addicts
Official Title
Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
April 16, 2020 (Anticipated)
Study Completion Date
April 16, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A case-controlled study is conducted to investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction.
Detailed Description
Objective: To investigate the effect of adjuvant laser meridian massage in heroin addicts with methadone treatment and establish the model of laser meridian massage treatment for drug addiction.
Methods: A case-controlled study is conducted. Fifteen male heroin addicts are enrolled from Addiction Treatment Center as treatment group. They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks. A control group of participants without laser meridian massage treatment are matched by age. Check urine morphine before, 2 and 4 weeks of treatment. Subjects report their times or days of heroin use and self-fill Visual Analogue Scales of heroin craving / refusal of heroin use (0-10 points) during last week before, 2 and 4 weeks of treatment. Subjects report their quality of life using Short Form-12v2 before and 4 weeks of treatment. Obtain the subject's pulse diagnosis and heart rate variability after a single treatment. Independent t test, Mann-Whitney U test, chi-square test and Fisher's exact test were used to compare the differences between the treatment and control groups. Repeated measures ANOVA, Generalized estimating equations, paired t test and Wilcoxon Signed-Rank test were used for comparison between the treatment and control groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
Keywords
Laser meridian massage, heroin addicts, methadone treatment, traditional Chinese medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
observational case-controlled study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser meridian massage
Arm Type
Experimental
Arm Description
They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A control group of participants without laser meridian massage treatment are matched by age.
Intervention Type
Device
Intervention Name(s)
laser meridian massage
Intervention Description
The participants will undergo 12 sessions of laser meridian massage, thrice a week, for 4 weeks, using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.5cm^2; power density, 300mW/cm^2; pulsed wave; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The laser treatment will be applied to the back including Bladder meridian (BL11-25) and Governor vessel (GV3-14) for 15 minutes, to deliver a total treatment dose of 67.5J/cm^2.
Primary Outcome Measure Information:
Title
Heroin use
Description
Times or days of heroin use during last week
Time Frame
2 weeks of treatment
Title
Heroin use
Description
Times or days of heroin use during last week
Time Frame
4 weeks of treatment
Title
Urine morphine
Description
Obtainurinary morphine concentration
Time Frame
2 weeks of treatment
Title
Urine morphine
Description
Obtain urinary morphine concentration
Time Frame
4 weeks of treatment
Secondary Outcome Measure Information:
Title
Heroin craving / refusal of heroin use
Description
Obtain Visual Analogue Scales (VAS) of heroin craving / refusal of heroin use (0-10 points) during last week. VAS score 0 of heroin craving indicates no heroin craving, while VAS 10 indicates strongest heroin craving. VAS 0 of refusal of heroin use indicates no refusal of heroin, while VAS 10 indicates absolute refusal of heroin.
Time Frame
2 weeks of treatment
Title
Heroin craving / refusal of heroin use
Description
Obtain Visual Analogue Scales (VAS) of heroin craving / refusal of heroin use (0-10 points) during last week. VAS score 0 of heroin craving indicates no heroin craving, while VAS 10 indicates strongest heroin craving. VAS 0 of refusal of heroin use indicates no refusal of heroin, while VAS 10 indicates absolute refusal of heroin.
Time Frame
4 weeks of treatment
Title
Short Form-12v2 Health Survey
Description
The SF-12v2® Health Survey (SF-12v2) is a multipurpose, short-form health survey with 12 questions that yields an eight-scale profile of functional health and well-being, as well as two psychometrically based physical and mental health summary measures and a preference-based health utility index.
The PRO CoRE, part of the Smart Measurement® System suite of products and Optum's upgrade to the QualityMetric Health Outcomes™ Scoring Software, is used for scoring the SF-12v2® Health Survey.
Time Frame
4 weeks of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide informed consent
Male older than 20 years
Diagnosed with opioid use disorder according to DSM-5 and received methadone treatment more than 1 month
Exclusion Criteria:
Received Antidepressant or antipsychotic
Received Chinese herb or acupuncture treatment during last 30 days
Critical illness
Did not meet the physician's assessment for recruitment
Patients with Human immunodeficiency virus infection
Did not provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Yi Chang
Phone
+886-3-3196200
Ext
3713
Email
ccyi@cgmh.org.tw
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Long Hu, MD, MS
Phone
+886-7-7317123
Ext
6255
Email
oolonghu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31574863
Citation
Hu WL, Tsai MC, Kuo CE, Liu CT, Wu SY, Wu TC, Hung YC. Adjuvant laser meridian massage in men with opioid use disorder on methadone maintenance treatment: Protocol for a case-controlled study. Medicine (Baltimore). 2019 Sep;98(39):e17319. doi: 10.1097/MD.0000000000017319.
Results Reference
derived
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Laser Meridian Massage in Heroin Addicts
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