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Osteopathic Treatment to Alcohol Withdrawal Syndrome (OSTEOOL)

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ClinicalTrials.gov Identifier: NCT03916939
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Ecole Supérieur d'Ostéopathie
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief Summary:

The alcohol withdrawal syndrome has a hierarchical symptomatology depending on the severity (minor, moderate or severe). These signs express a state of psychic, behavioral and physical deprivation.

The management of withdrawal syndrome involves the establishment of pharmacological and psychosocial interventions.

Osteopathy is an exclusively manual practice whose purpose is to overcome the dysfunction of mobility of tissues of the human body. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in reducing alcohol withdrawal symptoms in adult patients.


Condition or disease Intervention/treatment Phase
Alcohol Withdrawal Other: osteopathy Other: simulated osteopathy Not Applicable

Detailed Description:
The use of osteopathic techniques for facial equilibration decreases the severity of withdrawal symptoms experienced by patients hospitalized in a weekday hospital.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: simulated osteopathy
Primary Purpose: Other
Official Title: Contribution of Osteopathic Treatment to Alcohol Withdrawal Syndrome in Hospitalized Adult Patients
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : March 26, 2020
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: Osteopathy
osteopathic treatment
Other: osteopathy
osteopathy treatment

Placebo Comparator: simulated osteopathy
simulated osteopathic treatment
Other: simulated osteopathy
simulated osteopathic sessions




Primary Outcome Measures :
  1. Cushman score (0 to 27) [ Time Frame: Day one ]
    comparison between the two groupe of the cushamn socre between 11:30 am and 00:00 pm. questionary for alcohol dependency


Secondary Outcome Measures :
  1. CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67) [ Time Frame: day 0 ]
    comparison between the two groups with this questionary for alcohol withdrawal

  2. CIWA Ar test (0 to 67) [ Time Frame: day 1 ]
    comparison between the two groupe with this questionary for alcohol withdrawal

  3. CIWA Ar test (0 to 67) [ Time Frame: day 2 ]
    compariason between the two groups with this questionary for alcohol withdrawal

  4. CIWA Ar test (0 to 67) [ Time Frame: day 3 ]
    comparison between the two groups with this questionary for alcohol withdrawal

  5. CIWA Ar test (0 to 67) [ Time Frame: day 4 ]
    comparison between the two groups with this questionary for alcohol withdrawal

  6. cardiac frequency (beat per minute) [ Time Frame: day 1 ]
    mesurement of cardiac frequency and compaaison between the two groups

  7. cardiac frequency (beat per minute) [ Time Frame: day 3 ]
    mesurement of cardiac frequency and comparison between the two groups

  8. cardiac frequency (beat per minute) [ Time Frame: day 4 ]
    measurement of cardiac frequency and comparison between the two groups

  9. quality sleep scale (0 to 5) [ Time Frame: day 0 ]
    comparison between the two groups with sleep score

  10. quality sleep scale (0 to 5) [ Time Frame: day 1 ]
    comparison between the two groups with sleep score

  11. quality sleep scale (0 to 5) [ Time Frame: day 2 ]
    comparison between the two groups with sleep score

  12. quality sleep scale (0 to 5) [ Time Frame: day 3 ]
    comparison between the two groups with sleep score

  13. quality sleep scale (0 to 5) [ Time Frame: day 4 ]
    comparison between the two groups with sleep score

  14. quantity of benzodiazepine mg per 24 hours [ Time Frame: day 2 ]
    comparison between the two groups of benzodiazepin use

  15. quantity of benzodiazepine (mg per 24 hours) [ Time Frame: day 3 ]
    comparison between the two groups of benzodiazepin use

  16. quantity of benzodiazepine (mg per 24 hours) [ Time Frame: day 4 ]
    comparison betwenn the two groups of benzodiazepin use

  17. Cushmamn score (0 to 27) [ Time Frame: day 3 ]
    comparison between the two groups of the Cushamn score between 11:30 am and 00:00 pm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Age> 18 years
  • Patient hospitalized for a programmed alcohol withdrawal
  • Patient not abstinent with alcohol before hospitalization
  • Signed informed consent

Exclusion Criteria :

  • Minor patient
  • Patient with an addiction other than alcohol (except tobacco and benzodiazepines)
  • Previous participation in the OSTEOOL study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916939


Contacts
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Contact: camille JUNG, MD 01457022268 camille.jung@chicreteil.fr

Locations
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France
Chi Creteil Recruiting
Creteil, France, 94000
Contact: Camille BARRAULT, MD    06 62 89 61 27    camille.barrault@chicreteil.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Ecole Supérieur d'Ostéopathie

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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03916939     History of Changes
Other Study ID Numbers: OSTEOOL
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders