Laser Meridian Massage in Heroin Addicts

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

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.

Study Overview

• Status: Unknown
• Conditions: Heroin Dependence
• Intervention / Treatment: Device: laser meridian massage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Wen-Long Hu, MD, MS; Phone Number: 6255 +886-7-7317123; Email: oolonghu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laser meridian massage; They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks.	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.
NO_INTERVENTION: Control; A control group of participants without laser meridian massage treatment are matched by age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heroin use	Times or days of heroin use during last week	2 weeks of treatment
Heroin use	Times or days of heroin use during last week	4 weeks of treatment
Urine morphine	Obtainurinary morphine concentration	2 weeks of treatment
Urine morphine	Obtain urinary morphine concentration	4 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.	4 weeks of treatment

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Health and Welfare, Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2019
• Primary Completion (ANTICIPATED): April 16, 2020
• Study Completion (ANTICIPATED): April 16, 2020

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (ACTUAL): July 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: traditional Chinese medicine; Laser meridian massage; heroin addicts; methadone treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Heroin Dependence
• Other Study ID Numbers: PMRPG8J0081; M08G1056 (OTHER_GRANT: Ministry of Health and Welfare); 201801823A3 (OTHER: Chang Gung Medical Foundation Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No