Laser Meridian Massage in Heroin Addicts

Heroin Dependence Clinical Trial

Official title:

Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003077
• Other study ID #: PMRPG8J0081
• Secondary ID: M08G105620180182
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: April 16, 2020

Study information

• Verified date: June 2019
• Source: Chang Gung Memorial Hospital
• Contact: Cheng-Yi Chang
• Phone: +886-3-3196200
• Email: ccyi[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heroin Dependence

Intervention

Device:
• laser meridian massage
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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heroin use	Times or days of heroin use during last week	2 weeks of treatment
Primary	Heroin use	Times or days of heroin use during last week	4 weeks of treatment
Primary	Urine morphine	Obtainurinary morphine concentration	2 weeks of treatment
Primary	Urine morphine	Obtain urinary morphine concentration	4 weeks of treatment
Secondary	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.	2 weeks of treatment
Secondary	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.	4 weeks of treatment
Secondary	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 pro?le 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.	4 weeks of treatment