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Laser Meridian Massage in Heroin Addicts

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ClinicalTrials.gov Identifier: NCT04003077
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date July 4, 2019
Actual Study Start Date  ICMJE February 26, 2019
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Heroin use [ Time Frame: 2 weeks of treatment ]
    Times or days of heroin use during last week
  • Heroin use [ Time Frame: 4 weeks of treatment ]
    Times or days of heroin use during last week
  • Urine morphine [ Time Frame: 2 weeks of treatment ]
    Obtainurinary morphine concentration
  • Urine morphine [ Time Frame: 4 weeks of treatment ]
    Obtain urinary morphine concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04003077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Heroin craving / refusal of heroin use [ Time Frame: 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.
  • Heroin craving / refusal of heroin use [ Time Frame: 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.
  • Short Form-12v2 Health Survey [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Meridian Massage in Heroin Addicts
Official Title  ICMJE Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
observational case-controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heroin Dependence
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: laser meridian massage
  • No Intervention: Control
    A control group of participants without laser meridian massage treatment are matched by age.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2020
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheng-Yi Chang +886-3-3196200 ext 3713 ccyi@cgmh.org.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003077
Other Study ID Numbers  ICMJE PMRPG8J0081
M08G1056 ( Other Grant/Funding Number: Ministry of Health and Welfare )
201801823A3 ( Other Identifier: Chang Gung Medical Foundation Institutional Review Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Ministry of Health and Welfare, Taiwan
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP