Osteopathic Treatment to Alcohol Withdrawal Syndrome
OSTEOOL
Contribution of Osteopathic Treatment to Alcohol Withdrawal Syndrome in Hospitalized Adult Patients
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2018
CompletedFirst Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2024
CompletedJune 6, 2023
June 1, 2022
5.2 years
April 4, 2019
June 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67)
day 0
CIWA Ar test (0 to 67)
day 1
CIWA Ar test (0 to 67)
day 2
CIWA Ar test (0 to 67)
day 3
CIWA Ar test (0 to 67)
day 4
- +12 more secondary outcomes
Study Arms (2)
Osteopathy
EXPERIMENTALosteopathic treatment
simulated osteopathy
PLACEBO COMPARATORsimulated osteopathic treatment
Interventions
Eligibility Criteria
You may qualify if:
- Age\> 18 years
- Patient hospitalized for a programmed alcohol withdrawal
- Patient not abstinent with alcohol before hospitalization
- Signed informed consent
You may not qualify if:
- Minor patient
- Patient with an addiction other than alcohol (except tobacco and benzodiazepines)
- Previous participation in the OSTEOOL study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chi Creteil
Créteil, 94000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- simulated osteopathy
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 16, 2019
Study Start
September 26, 2018
Primary Completion
December 13, 2023
Study Completion
February 13, 2024
Last Updated
June 6, 2023
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share