Alcohol WithdrawalOSTEOOLNCT03916939
Osteopathic Treatment to Alcohol Withdrawal Syndrome
A study testing osteopathy and simulated osteopathy in people with Alcohol Withdrawal, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Withdrawal
- What is being tested?
- osteopathy and simulated osteopathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2018to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age> 18 years
- Patient hospitalized for a programmed alcohol withdrawal
- Patient not abstinent with alcohol before hospitalization
- Signed informed consent
Who cannot join
- Minor patient
- Patient with an addiction other than alcohol (except tobacco and benzodiazepines)
- Previous participation in the OSTEOOL study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The use of osteopathic techniques for facial equilibration decreases the severity of withdrawal symptoms experienced by patients hospitalized in a weekday hospital.
- Conditions
- Alcohol Withdrawal
- Being tested
- osteopathy, simulated osteopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathyOther
osteopathy treatment
simulated osteopathyOther
simulated osteopathic sessions
| Study group | Role | What they receive |
|---|---|---|
| Osteopathy | Experimental | osteopathic treatment Receives: Other: osteopathy |
| simulated osteopathy | Placebo comparator | simulated osteopathic treatment Receives: Other: simulated osteopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day one
Secondary outcomes (17)
CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67)
comparison between the two groups with this questionary for alcohol withdrawal
Measured: day 0
CIWA Ar test (0 to 67)
comparison between the two groupe with this questionary for alcohol withdrawal
Measured: day 1
CIWA Ar test (0 to 67)
compariason between the two groups with this questionary for alcohol withdrawal
Measured: day 2
CIWA Ar test (0 to 67)
comparison between the two groups with this questionary for alcohol withdrawal
Measured: day 3
CIWA Ar test (0 to 67)
comparison between the two groups with this questionary for alcohol withdrawal
Measured: day 4
cardiac frequency (beat per minute)
mesurement of cardiac frequency and compaaison between the two groups
Measured: day 1
cardiac frequency (beat per minute)
mesurement of cardiac frequency and comparison between the two groups
Measured: day 3
cardiac frequency (beat per minute)
measurement of cardiac frequency and comparison between the two groups
Measured: day 4
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
Measured: day 0
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
Measured: day 1
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
Measured: day 2
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
Measured: day 3
quality sleep scale (0 to 5)
comparison between the two groups with sleep score
Measured: day 4
quantity of benzodiazepine mg per 24 hours
comparison between the two groups of benzodiazepin use
Measured: day 2
quantity of benzodiazepine (mg per 24 hours)
comparison between the two groups of benzodiazepin use
Measured: day 3
quantity of benzodiazepine (mg per 24 hours)
comparison betwenn the two groups of benzodiazepin use
Measured: day 4
Cushmamn score (0 to 27)
comparison between the two groups of the Cushamn score between 11:30 am and 00:00 pm
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start17 Dec 2018
- Primary completion23 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Supérieur d'Ostéopathie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916939
- Sponsor's protocol ID
- OSTEOOL
- Acronym
- OSTEOOL
- Status last verified
- Jun 2026
- First submitted
- 4 Apr 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Osteopathic Treatment to Alcohol Withdrawal Syndrome in Hospitalized Adult Patients
- ClinicalTrials.gov ID
- NCT03916939
- Acronym / sponsor ID
- OSTEOOL / OSTEOOL
- Conditions
- Alcohol Withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Ecole Supérieur d'Ostéopathie
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathy | Experimental | Other: osteopathyosteopathic treatment |
| simulated osteopathy | Placebo comparator | Other: simulated osteopathysimulated osteopathic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18 years
- Patient hospitalized for a programmed alcohol withdrawal
- Patient not abstinent with alcohol before hospitalization
- Signed informed consent
Key exclusion criteria (3 listed)
- Minor patient
- Patient with an addiction other than alcohol (except tobacco and benzodiazepines)
- Previous participation in the OSTEOOL study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopathyosteopathy treatment | Other | Osteopathy |
| simulated osteopathysimulated osteopathic sessions | Other | simulated osteopathy |
Primary outcome
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
17 secondary outcomes
CIWA Ar (Clinicial Institute Withdrawal Assessment - Alcohol Revised) test (0 to 67)
Time frame: day 0
CIWA Ar test (0 to 67)
Time frame: day 1
CIWA Ar test (0 to 67)
Time frame: day 2
CIWA Ar test (0 to 67)
Time frame: day 3
CIWA Ar test (0 to 67)
Time frame: day 4
cardiac frequency (beat per minute)
Time frame: day 1
cardiac frequency (beat per minute)
Time frame: day 3
cardiac frequency (beat per minute)
Time frame: day 4
quality sleep scale (0 to 5)
Time frame: day 0
quality sleep scale (0 to 5)
Time frame: day 1
quality sleep scale (0 to 5)
Time frame: day 2
quality sleep scale (0 to 5)
Time frame: day 3
quality sleep scale (0 to 5)
Time frame: day 4
quantity of benzodiazepine mg per 24 hours
Time frame: day 2
quantity of benzodiazepine (mg per 24 hours)
Time frame: day 3
quantity of benzodiazepine (mg per 24 hours)
Time frame: day 4
Cushmamn score (0 to 27)
Time frame: day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathy and simulated osteopathy in people with Alcohol Withdrawal, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cushman score (0 to 27) (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.