Osteopathic Treatment to Alcohol Withdrawal Syndrome (OSTEOOL)
Primary Purpose
Alcohol Withdrawal
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
osteopathy
simulated osteopathy
Sponsored by
About this trial
This is an interventional other trial for Alcohol Withdrawal
Eligibility 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
Sites / Locations
- Chi CreteilRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Osteopathy
simulated osteopathy
Arm Description
osteopathic treatment
simulated osteopathic treatment
Outcomes
Primary Outcome Measures
Cushman score (0 to 27)
comparison between the two groupe of the cushamn socre between 11:30 am and 00:00 pm. questionary for alcohol dependency
Secondary Outcome Measures
CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67)
comparison between the two groups with this questionary for alcohol withdrawal
CIWA Ar test (0 to 67)
comparison between the two groupe with this questionary for alcohol withdrawal
CIWA Ar test (0 to 67)
compariason between the two groups with this questionary for alcohol withdrawal
CIWA Ar test (0 to 67)
comparison between the two groups with this questionary for alcohol withdrawal
CIWA Ar test (0 to 67)
comparison between the two groups with this questionary for alcohol withdrawal
cardiac frequency (beat per minute)
mesurement of cardiac frequency and compaaison between the two groups
cardiac frequency (beat per minute)
mesurement of cardiac frequency and comparison between the two groups
cardiac frequency (beat per minute)
measurement of cardiac frequency and comparison between the two groups
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
quantity of benzodiazepine mg per 24 hours
comparison between the two groups of benzodiazepin use
quantity of benzodiazepine (mg per 24 hours)
comparison between the two groups of benzodiazepin use
quantity of benzodiazepine (mg per 24 hours)
comparison betwenn the two groups of benzodiazepin use
Cushmamn score (0 to 27)
comparison between the two groups of the Cushamn score between 11:30 am and 00:00 pm
Full Information
NCT ID
NCT03916939
First Posted
April 4, 2019
Last Updated
June 5, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Ecole Supérieur d'Ostéopathie
1. Study Identification
Unique Protocol Identification Number
NCT03916939
Brief Title
Osteopathic Treatment to Alcohol Withdrawal Syndrome
Acronym
OSTEOOL
Official Title
Contribution of Osteopathic Treatment to Alcohol Withdrawal Syndrome in Hospitalized Adult Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
December 13, 2023 (Anticipated)
Study Completion Date
February 13, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Ecole Supérieur d'Ostéopathie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The use of osteopathic techniques for facial equilibration decreases the severity of withdrawal symptoms experienced by patients hospitalized in a weekday hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
simulated osteopathy
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteopathy
Arm Type
Experimental
Arm Description
osteopathic treatment
Arm Title
simulated osteopathy
Arm Type
Placebo Comparator
Arm Description
simulated osteopathic treatment
Intervention Type
Other
Intervention Name(s)
osteopathy
Intervention Description
osteopathy treatment
Intervention Type
Other
Intervention Name(s)
simulated osteopathy
Intervention Description
simulated osteopathic sessions
Primary Outcome Measure Information:
Title
Cushman score (0 to 27)
Description
comparison between the two groupe of the cushamn socre between 11:30 am and 00:00 pm. questionary for alcohol dependency
Time Frame
Day one
Secondary Outcome Measure Information:
Title
CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67)
Description
comparison between the two groups with this questionary for alcohol withdrawal
Time Frame
day 0
Title
CIWA Ar test (0 to 67)
Description
comparison between the two groupe with this questionary for alcohol withdrawal
Time Frame
day 1
Title
CIWA Ar test (0 to 67)
Description
compariason between the two groups with this questionary for alcohol withdrawal
Time Frame
day 2
Title
CIWA Ar test (0 to 67)
Description
comparison between the two groups with this questionary for alcohol withdrawal
Time Frame
day 3
Title
CIWA Ar test (0 to 67)
Description
comparison between the two groups with this questionary for alcohol withdrawal
Time Frame
day 4
Title
cardiac frequency (beat per minute)
Description
mesurement of cardiac frequency and compaaison between the two groups
Time Frame
day 1
Title
cardiac frequency (beat per minute)
Description
mesurement of cardiac frequency and comparison between the two groups
Time Frame
day 3
Title
cardiac frequency (beat per minute)
Description
measurement of cardiac frequency and comparison between the two groups
Time Frame
day 4
Title
quality sleep scale (0 to 5)
Description
comparison between the two groups with sleep score
Time Frame
day 0
Title
quality sleep scale (0 to 5)
Description
comparison between the two groups with sleep score
Time Frame
day 1
Title
quality sleep scale (0 to 5)
Description
comparison between the two groups with sleep score
Time Frame
day 2
Title
quality sleep scale (0 to 5)
Description
comparison between the two groups with sleep score
Time Frame
day 3
Title
quality sleep scale (0 to 5)
Description
comparison between the two groups with sleep score
Time Frame
day 4
Title
quantity of benzodiazepine mg per 24 hours
Description
comparison between the two groups of benzodiazepin use
Time Frame
day 2
Title
quantity of benzodiazepine (mg per 24 hours)
Description
comparison between the two groups of benzodiazepin use
Time Frame
day 3
Title
quantity of benzodiazepine (mg per 24 hours)
Description
comparison betwenn the two groups of benzodiazepin use
Time Frame
day 4
Title
Cushmamn score (0 to 27)
Description
comparison between the two groups of the Cushamn score between 11:30 am and 00:00 pm
Time Frame
day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
camille JUNG, MD
Phone
01457022268
Email
camille.jung@chicreteil.fr
Facility Information:
Facility Name
Chi Creteil
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille BARRAULT, MD
Phone
06 62 89 61 27
Email
camille.barrault@chicreteil.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Osteopathic Treatment to Alcohol Withdrawal Syndrome
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