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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03916939
Other study ID # OSTEOOL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 26, 2018
Est. completion date February 13, 2024

Study information

Verified date June 2022
Source Centre Hospitalier Intercommunal Creteil
Contact camille JUNG, MD
Phone 01457022268
Email camille.jung@chicreteil.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date February 13, 2024
Est. primary completion date December 13, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
osteopathy
osteopathy treatment
simulated osteopathy
simulated osteopathic sessions

Locations

Country Name City State
France Chi Creteil Creteil

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil Ecole Supérieur d'Ostéopathie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day one
Secondary CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67) comparison between the two groups with this questionary for alcohol withdrawal day 0
Secondary CIWA Ar test (0 to 67) comparison between the two groupe with this questionary for alcohol withdrawal day 1
Secondary CIWA Ar test (0 to 67) compariason between the two groups with this questionary for alcohol withdrawal day 2
Secondary CIWA Ar test (0 to 67) comparison between the two groups with this questionary for alcohol withdrawal day 3
Secondary CIWA Ar test (0 to 67) comparison between the two groups with this questionary for alcohol withdrawal day 4
Secondary cardiac frequency (beat per minute) mesurement of cardiac frequency and compaaison between the two groups day 1
Secondary cardiac frequency (beat per minute) mesurement of cardiac frequency and comparison between the two groups day 3
Secondary cardiac frequency (beat per minute) measurement of cardiac frequency and comparison between the two groups day 4
Secondary quality sleep scale (0 to 5) comparison between the two groups with sleep score day 0
Secondary quality sleep scale (0 to 5) comparison between the two groups with sleep score day 1
Secondary quality sleep scale (0 to 5) comparison between the two groups with sleep score day 2
Secondary quality sleep scale (0 to 5) comparison between the two groups with sleep score day 3
Secondary quality sleep scale (0 to 5) comparison between the two groups with sleep score day 4
Secondary quantity of benzodiazepine mg per 24 hours comparison between the two groups of benzodiazepin use day 2
Secondary quantity of benzodiazepine (mg per 24 hours) comparison between the two groups of benzodiazepin use day 3
Secondary quantity of benzodiazepine (mg per 24 hours) comparison betwenn the two groups of benzodiazepin use day 4
Secondary Cushmamn score (0 to 27) comparison between the two groups of the Cushamn score between 11:30 am and 00:00 pm day 3
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