Cystic FibrosisPhase 3MUCOSTEONCT01293019
Osteopathic Treatment in Adult Patients With Cystic Fibrosis
A Phase 3 study testing Osteopathic treatment in people with Cystic Fibrosis and Back Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Back Pain, Neck Pain
- What is being tested?
- Osteopathic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2009to Dec 2011
- Phase
- Phase 3
- 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
- Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene
- Age > 18 years
- Patient with chronic chest , neck or back pain
- Written Informed Consent
- with health insurance
Who cannot join
- regular follow-up by an osteopathic physician in the previous 3 months
- patients awaiting lung transplantation
- history of lung transplantation
- pregnancy
- understanding disorders preventing the patient to apply the study
- participation in another clinical interventional study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study
To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis
Read the detailed description
To compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.
- Conditions
- Cystic Fibrosis, Back Pain, Neck Pain, Chest Pain
- Being tested
- Osteopathic treatment, Sham Placebo, Usual care
- Keywords
- Complementary and alternative medicine, Osteopathic treatment
- Medical subject headings
- Cystic Fibrosis, Back Pain, Neck Pain, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentProcedure or surgery
Also called Real treatment of osteopathy
Real treatment of osteopathy
Sham PlaceboProcedure or surgery
Also called Sham treatment of osteopathy
Sham treatment of osteopathy
Usual careProcedure or surgery
Also called Classical treatment of pain in cystic fibrosis patients
Classical treatment of pain in cystic fibrosis patients
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Osteopathic treatment Receives: Procedure: Osteopathic treatment |
| Placebo | Placebo comparator | Sham osteopathic treatment Receives: Procedure: Sham Placebo |
| Usual care | Active comparator | Classic treatment of cystic fibrosis patients Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: at 6 months
Secondary outcomes (2)
quality of life scores
Measured: at 6 months
Co-interventions
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study start5 Nov 2009
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dominique Hubert, MD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293019
- Sponsor's protocol ID
- P080701
- Acronym
- MUCOSTEO
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2011
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Hubert D, Soubeiran L, Gourmelon F, Grenet D, Serreau R, Perrodeau E, Zegarra-Parodi R, Boutron I. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study. PLoS One. 2014 Jul 16;9(7):e102465. doi: 10.1371/journal.pone.0102465. eCollection 2014.
PubMed 25029347
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Osteopathic Manipulative Treatment on Pain of Adult Patients With Cystic Fibrosis - a Pilot Study
- ClinicalTrials.gov ID
- NCT01293019
- Acronym / sponsor ID
- MUCOSTEO / P080701
- Conditions
- Cystic Fibrosis, Back Pain, Neck Pain, Chest Pain
- Keywords
- Complementary and alternative medicine, Osteopathic treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Nov 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Feb 2011 (estimated)
- 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.
To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis
Detailed description
To compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Osteopathic treatmentOsteopathic treatment |
| Placebo | Placebo comparator | Procedure: Sham PlaceboSham osteopathic treatment |
| Usual care | Active comparator | Procedure: Usual careClassic treatment of cystic fibrosis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene
- Age > 18 years
- Patient with chronic chest , neck or back pain
- Written Informed Consent
- with health insurance
Key exclusion criteria (6 listed)
- regular follow-up by an osteopathic physician in the previous 3 months
- patients awaiting lung transplantation
- history of lung transplantation
- pregnancy
- understanding disorders preventing the patient to apply the 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 |
|---|---|---|
| Osteopathic treatmentAlso: Real treatment of osteopathyReal treatment of osteopathy | Procedure or surgery | Experimental |
| Sham PlaceboAlso: Sham treatment of osteopathySham treatment of osteopathy | Procedure or surgery | Placebo |
| Usual careAlso: Classical treatment of pain in cystic fibrosis patientsClassical treatment of pain in cystic fibrosis patients | Procedure or surgery | Usual care |
Primary outcome
Pain score
Time frame: at 6 months
2 secondary outcomes
quality of life scores
Time frame: at 6 months
Co-interventions
Time frame: at 6 months
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 7 Jul 2026.
- Results publication: PubMed 25029347Hubert D, Soubeiran L, Gourmelon F, Grenet D, Serreau R, Perrodeau E, Zegarra-Parodi R, Boutron I. Impact of osteopathic treatment on pain in adult patients with cystic fibrosis--a pilot randomized controlled study. PLoS One. 2014 Jul 16;9(7):e102465. doi: 10.1371/journal.pone.0102465. eCollection 2014.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Dominique Hubert, MD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osteopathic treatment in people with Cystic Fibrosis and Back Pain, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 6 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 7 Jul 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain score (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293019, which also lists 1 linked publication.
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 7 Jul 2026.