Osteopathic Treatment to Alcohol Withdrawal Syndrome (OSTEOOL)

Contribution of Osteopathic Treatment to Alcohol Withdrawal Syndrome in Hospitalized Adult Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Withdrawal
• Intervention / Treatment: Other: osteopathy; Other: simulated osteopathy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: camille JUNG, MD; Phone Number: 01457022268; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Creteil, France, 94000
    • Recruiting
    • CHI Créteil
    • Contact: Camille BARRAULT, MD; Phone Number: 06 62 89 61 27; Email: camille.barrault@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathy; osteopathic treatment	Other: osteopathy; osteopathy treatment
Placebo Comparator: simulated osteopathy; simulated osteopathic treatment	Other: simulated osteopathy; simulated osteopathic sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
CIWA Ar test (0 to 67)	comparison between the two groupe with this questionary for alcohol withdrawal	day 1
CIWA Ar test (0 to 67)	compariason between the two groups with this questionary for alcohol withdrawal	day 2
CIWA Ar test (0 to 67)	comparison between the two groups with this questionary for alcohol withdrawal	day 3
CIWA Ar test (0 to 67)	comparison between the two groups with this questionary for alcohol withdrawal	day 4
cardiac frequency (beat per minute)	mesurement of cardiac frequency and compaaison between the two groups	day 1
cardiac frequency (beat per minute)	mesurement of cardiac frequency and comparison between the two groups	day 3
cardiac frequency (beat per minute)	measurement of cardiac frequency and comparison between the two groups	day 4
quality sleep scale (0 to 5)	comparison between the two groups with sleep score	day 0
quality sleep scale (0 to 5)	comparison between the two groups with sleep score	day 1
quality sleep scale (0 to 5)	comparison between the two groups with sleep score	day 2
quality sleep scale (0 to 5)	comparison between the two groups with sleep score	day 3
quality sleep scale (0 to 5)	comparison between the two groups with sleep score	day 4
quantity of benzodiazepine mg per 24 hours	comparison between the two groups of benzodiazepin use	day 2
quantity of benzodiazepine (mg per 24 hours)	comparison between the two groups of benzodiazepin use	day 3
quantity of benzodiazepine (mg per 24 hours)	comparison betwenn the two groups of benzodiazepin use	day 4
Cushmamn score (0 to 27)	comparison between the two groups of the Cushamn score between 11:30 am and 00:00 pm	day 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Ecole Supérieur d'Ostéopathie

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Estimated): December 13, 2023
• Study Completion (Estimated): February 13, 2024

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome
• Other Study ID Numbers: OSTEOOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No