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Status unknownNCT04003077Updated Mar 16, 2020

Laser Meridian Massage in Heroin Addicts

An interventional study of laser meridian massage in Heroin Dependence, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to male participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-16.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2019, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Heroin Dependence

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Keywords

  • Laser meridian massage
  • heroin addicts
  • methadone treatment
  • traditional Chinese medicine
03

In context

Heroin Dependence

90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.

This study's planned enrollment of 30 is below the median of 87 across 57 interventional studies indexed under Heroin Dependence.

Browse Heroin Dependence studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provide
  • Male older than 20 years
  • Diagnosed with opioid use disorder according to and received methadone treatment more than 1 month

Exclusion criteria

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 infection
  • Did not provide
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

HIV

The human immunodeficiency virus, which weakens the immune system.

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • No intervention
    Control

    A control group of participants without laser meridian massage treatment are matched by age.

Interventions

  • Devicelaser 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.

06

What researchers measure

Primary outcomes

  1. Heroin use

    Times or days of heroin use during last week

    Time frame: 2 weeks of treatment

  2. Heroin use

    Times or days of heroin use during last week

    Time frame: 4 weeks of treatment

  3. Urine morphine

    Obtainurinary morphine concentration

    Time frame: 2 weeks of treatment

  4. Urine morphine

    Obtain urinary morphine concentration

    Time frame: 4 weeks of treatment

Secondary outcomes

  1. 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.

    Time frame: 2 weeks of treatment

  2. 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.

    Time frame: 4 weeks of treatment

  3. 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.

    Time frame: 4 weeks of treatment

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung, 833, Taiwan
    Recruiting
08

References and documents

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. PubMed 31574863 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04003077
Collaborators
Ministry of Health and Welfare, Taiwan
Responsible party
Sponsor
First posted
Jul 1, 2019
Start date
Feb 26, 2019
Primary completion
Apr 16, 2020 (estimated)
Completion
Apr 16, 2020 (estimated)
Last update
Mar 16, 2020

Study contacts

Cheng-Yi Chang
Contact
ccyi@cgmh.org.tw
+886-3-3196200 ext. 3713

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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