OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTSNCT05230277
OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS
A study testing the active osteopathic treatment (AOT) in people with OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS, run by Centre Hospitalier de Troyes.
Trial summary
Osteopathy is chosen by patients as a treatment for IBS but the evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS
- What is being tested?
- the active osteopathic treatment (AOT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 ans
- IBS patients (defined according to the Rome IV Criteria)
- Moderate symptom severity score on the IBS Symptom Severity Scale (IBS-SSS) (values ranging from 175 to 300).
- Negative colonoscopy within the last 5 years.
- Psychologically fit to provide signed informed consent.
- Agreed to undergo the procedures associated with the study
- Medical insurance
Who cannot join
- Have not received any osteopathic treatment in the last 12 months
- Chronic inflammatory bowel disease or digestive cancer (even if the disease is in remission)
- Pregnancy
- Planned or expected elective surgery during the study
- Dietary and lifestyle changes in the previous month.
- Use of prohibited concomitant medications in the previous month.
- Inability to understand or cooperate during the study.
- No current participation in a biomedical research trial.
About this study
Official title: OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL
Osteopathy is chosen by patients as a treatment for IBS but the evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.
Read the detailed description
a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group: active osteopathic treatment. Control group: sham osteopathic treatment. Randomization: allocation ratio 1:1. Assessment times: inclusion and baseline assessment (Day-1; Initial visit V0), Day 8, Day 15 and follow-up (1 month and 3 months), treatments (Day 0, Day 8, Day 15). Primary endpoint: Effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint: Effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size: 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).
- Being tested
- the active osteopathic treatment (AOT), the sham osteopathic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the active osteopathic treatment (AOT)Other
The AOT will first consist of the application of a visceral technique. The patient will lie on their stomach and the osteopath will touch the patient's abdomen with a wide two-handed grip. The action will consist of following the abdominal tissues in directions where tissue mobility is allowed and occurs without restriction, from the surface to the depth of the abdomen. A change in the elasticity of the colon will then be perceived when the mobility restrictions of the tissues are dissipated. The osteopath will then use a technique on the sacrum according toik-g the procedure described by Attali et al. [8] which consists in mobilizing the sacrum between the iliac bones.
the sham osteopathic treatmentOther
For SOT, the patient will lie on their stomach and the osteopath will use a wide two-handed grip on the patient's abdomen to deliberately mobilize it in an imprecise manner. Next, a technique with no apparent therapeutic effects, the light touch, first described by Licciardone et al. [13] and proposed by others to perform simulated bone manipulations [14], will be applied to the sacrum
| Study group | Role | What they receive |
|---|---|---|
| The experimental group is defined by the sham osteopathic treatment (SOT) | Placebo comparator | Patients will receive 3 SOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the SOT. The positions of the patient and the practitioner will be the same as in the AOT group Receives: Other: the sham osteopathic treatment |
| The experimental group is defined by the active osteopathic treatment (AOT) | Experimental | Patients will receive 3 AOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the AOT. Receives: Other: the active osteopathic treatment (AOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness (response to treatment) at 1-month follow-up:
It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment.
Measured: 1 month
Secondary outcomes (1)
Effectiveness at 3 months (response to treatment based on the IBS-SSS) and changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 months.
It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment.
Changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 monthsThe IBS-QOL is a self-report measure of quality of life specific to irritable bowel syndrome (IBS) often used to assess the impact of IBS and its treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Troyes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230277
- Sponsor's protocol ID
- TREAT OF IBS SYMPTOMS IN ADULT
- Status last verified
- Mar 2023
- First submitted
- 13 Jan 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05230277
- Acronym / sponsor ID
- TREAT OF IBS SYMPTOMS IN ADULT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Centre Hospitalier de TroyesUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 8 Feb 2022 (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.
Osteopathy is chosen by patients as a treatment for IBS but the evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.
Detailed description
a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group: active osteopathic treatment. Control group: sham osteopathic treatment. Randomization: allocation ratio 1:1. Assessment times: inclusion and baseline assessment (Day-1; Initial visit V0), Day 8, Day 15 and follow-up (1 month and 3 months), treatments (Day 0, Day 8, Day 15). Primary endpoint: Effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint: Effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size: 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group is defined by the sham osteopathic treatment (SOT) | Placebo comparator | Other: the sham osteopathic treatmentPatients will receive 3 SOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the SOT. The positions of the patient and the practitioner will be the same as in the AOT group |
| The experimental group is defined by the active osteopathic treatment (AOT) | Experimental | Other: the active osteopathic treatment (AOT)Patients will receive 3 AOT of 30 minutes each for 2 weeks in a private practice by an experienced osteopath who will receive prior training to optimize the quality of the AOT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients ≥ 18 ans
- IBS patients (defined according to the Rome IV Criteria)
- Moderate symptom severity score on the IBS Symptom Severity Scale (IBS-SSS) (values ranging from 175 to 300).
- Negative colonoscopy within the last 5 years.
- Psychologically fit to provide signed informed consent.
Key exclusion criteria (8 listed)
- Have not received any osteopathic treatment in the last 12 months
- Chronic inflammatory bowel disease or digestive cancer (even if the disease is in remission)
- Pregnancy
- Planned or expected elective surgery during the study
- Dietary and lifestyle changes in the previous month.
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 |
|---|---|---|
| the active osteopathic treatment (AOT)The AOT will first consist of the application of a visceral technique. The patient will lie on their stomach and the osteopath will touch the patient's abdomen with a wide two-handed grip. The action will consist of following the abdominal tissues in directions where tissue mobility is allowed and occurs without restriction, from the surface to the depth of the abdomen. A change in the elasticity of the colon will then be perceived when the mobility restrictions of the tissues are dissipated. The osteopath will then use a technique on the sacrum according toik-g the procedure described by Attali et al. [8] which consists in mobilizing the sacrum between the iliac bones. | Other | The experimental group is defined by the active osteopathic treatment (AOT) |
| the sham osteopathic treatmentFor SOT, the patient will lie on their stomach and the osteopath will use a wide two-handed grip on the patient's abdomen to deliberately mobilize it in an imprecise manner. Next, a technique with no apparent therapeutic effects, the light touch, first described by Licciardone et al. [13] and proposed by others to perform simulated bone manipulations [14], will be applied to the sacrum | Other | The experimental group is defined by the sham osteopathic treatment (SOT) |
Primary outcome
The effectiveness (response to treatment) at 1-month follow-up:
Time frame: 1 month
It is measured by the IBS symptoms severity score (IBS-SSS) after osteopathic treatment. The IBS-SSS is a validated measure to assess the severity of IBS symptoms, and allows monitoring of the response to treatment.
1 secondary outcome
Effectiveness at 3 months (response to treatment based on the IBS-SSS) and changes in total IBS-Quality Of Life (IBS-QOL) scores up to 3 months.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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.
Questions about this trial
What is this clinical trial studying?
A study testing the active osteopathic treatment (AOT) in people with OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS, run by Centre Hospitalier de Troyes.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The effectiveness (response to treatment) at 1-month follow-up: (time frame: 1 month). 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 2 Mar 2023.