MedPath

Laser Meridian Massage in Heroin Addicts

Not Applicable
Conditions
Heroin Dependence
Interventions
Device: laser meridian massage
Registration Number
NCT04003077
Lead Sponsor
Chang Gung Memorial Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Male
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Laser meridian massagelaser meridian massageThey are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks.
Primary Outcome Measures
NameTimeMethod
Urine morphine4 weeks of treatment

Obtain urinary morphine concentration

Heroin use4 weeks of treatment

Times or days of heroin use during last week

Secondary Outcome Measures
NameTimeMethod
Heroin craving / refusal of heroin use4 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.

Short Form-12v2 Health Survey4 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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital

🇨🇳

Kaohsiung, Taiwan

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