Laser Meridian Massage in Heroin Addicts

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04003077
Collaborator
Ministry of Health and Welfare, Taiwan (Other)
30
1
2
13.6
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: laser meridian massage
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
observational case-controlled studyobservational case-controlled study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study
Actual Study Start Date :
Feb 26, 2019
Anticipated Primary Completion Date :
Apr 16, 2020
Anticipated Study Completion Date :
Apr 16, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Heroin use [2 weeks of treatment]

    Times or days of heroin use during last week

  2. Heroin use [4 weeks of treatment]

    Times or days of heroin use during last week

  3. Urine morphine [2 weeks of treatment]

    Obtainurinary morphine concentration

  4. Urine morphine [4 weeks of treatment]

    Obtain urinary morphine concentration

Secondary Outcome Measures

  1. Heroin craving / refusal of heroin use [2 weeks of treatment]

    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. Heroin craving / refusal of heroin use [4 weeks of treatment]

    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.

  3. Short Form-12v2 Health Survey [4 weeks of treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 833

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04003077
Other Study ID Numbers:
  • PMRPG8J0081
  • M08G1056
  • 201801823A3
First Posted:
Jul 1, 2019
Last Update Posted:
Mar 16, 2020
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2020