FibromyalgiaFMostéoNCT02805673
Osteopathic Support Evaluation of Fibromyalgia Patients
A study testing Osteopathy in people with Fibromyalgia, run by University Hospital, Caen at 1 site in France.
Trial summary
At present, the literature does not account for much of scientific data on the assessment of osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic interventions in the treatment of FM, in order… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Osteopathy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2015to 17 Dec 2019
- 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
- FM patient diagnosed according to the ACR criteria.
- Patient Having realized biological balances excluding any underlying pathology that may be causing the pain.
- Patient Over 18 years followed at Caen University Hospital.
- Patient Treated with drugs to its FM.
- Patient Being informed and having signed his consent.
- Patient Affiliated to the social security system.
- French-Patient.
Who cannot join
- FM undiagnosed according to the ACR criteria.
- Patient Showing against -indications to the osteopathic surgery.
- Patient Treated by manual therapy ( physiotherapy, osteopathy, acupuncture... ) during the trial and during the three months preceding the study.
- Concomitant Maladie (type cancers, cardiovascular diseases, rheumatic diseases ) or all diseases causing bone pain and myalgia.
- Important Surgery of less than 3 months.
- Inability to submit to medical monitoring study for geographical or social reasons.
- Inclusion The subject in another biomedical research protocol for this study.
- Women Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
At present, the literature does not account for much of scientific data on the assessment of osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic interventions in the treatment of FM, in order to improve the painful experiences of FM patients. This study must include 44 patients with FM according to (American College of Rheumatology) ACR criteria and followed the University Hospital of Caen.
The osteopathic care will last eight months and will be followed by a report three months after the end of osteopathic interventions. This in order to evaluate the effect in the short term and long term, of osteopathic care in patients with FM.
- Conditions
- Fibromyalgia
- Being tested
- Osteopathy
- Keywords
- Osteopathy, Support, Treatment, Pain, Quality of Life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteopathyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| OSTEO group | Experimental | usual medical treatment + 6 osteopathic interventions Receives: Procedure: Osteopathy |
| witness group | No intervention | usual medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for pain
Measured: chenge between Day 232 - Day 0
Secondary outcomes (4)
Visual Analogue Scale for pain
Measured: change after Week 6, Week 12, Week 18, Week 24, Week 32, Week 38 and day 301, compared to day 0
QDSA score
Measured: at day 232 until day 301 and compared to day 0
SF-36 score
Measured: at day 232 until day 301 and compared to day 0
number of tender points
Measured: at day 232 to day 301 and compared to day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start22 Apr 2015
- Primary completion17 Dec 2018
- Study completion17 Dec 2019
Why it stopped: lack of patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise CF COURTHEOUX, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805673
- Sponsor's protocol ID
- 2014-A00687-40
- Acronym
- FMostéo
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2016
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Support Evaluation of Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT02805673
- Acronym / sponsor ID
- FMostéo / 2014-A00687-40
- Conditions
- Fibromyalgia
- Keywords
- Osteopathy, Support, Treatment, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patient
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 22 Apr 2015 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 20 Jun 2016 (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.
At present, the literature does not account for much of scientific data on the assessment of osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic interventions in the treatment of FM, in order to improve the painful experiences of FM patients. This study must include 44 patients with FM according to (American College of Rheumatology) ACR criteria and followed the University Hospital of Caen.
The osteopathic care will last eight months and will be followed by a report three months after the end of osteopathic interventions. This in order to evaluate the effect in the short term and long term, of osteopathic care in patients with FM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSTEO group | Experimental | Procedure: Osteopathyusual medical treatment + 6 osteopathic interventions |
| witness group | No intervention | –usual medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- FM patient diagnosed according to the ACR criteria.
- Patient Having realized biological balances excluding any underlying pathology that may be causing the pain.
- Patient Over 18 years followed at Caen University Hospital.
- Patient Treated with drugs to its FM.
- Patient Being informed and having signed his consent.
Key exclusion criteria (8 listed)
- FM undiagnosed according to the ACR criteria.
- Patient Showing against -indications to the osteopathic surgery.
- Patient Treated by manual therapy ( physiotherapy, osteopathy, acupuncture... ) during the trial and during the three months preceding the study.
- Concomitant Maladie (type cancers, cardiovascular diseases, rheumatic diseases ) or all diseases causing bone pain and myalgia.
- Important Surgery of less than 3 months.
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 |
|---|---|---|
| Osteopathy | Procedure or surgery | OSTEO group |
Primary outcome
Visual Analogue Scale for pain
Time frame: chenge between Day 232 - Day 0
4 secondary outcomes
Visual Analogue Scale for pain
Time frame: change after Week 6, Week 12, Week 18, Week 24, Week 32, Week 38 and day 301, compared to day 0
QDSA score
Time frame: at day 232 until day 301 and compared to day 0
SF-36 score
Time frame: at day 232 until day 301 and compared to day 0
number of tender points
Time frame: at day 232 to day 301 and compared to day 0
Results and safety
The study was stopped early (reason given: lack of patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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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.
Françoise CF COURTHEOUX, MD principal investigator
University Hospital, Caen
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 in people with Fibromyalgia, run by University Hospital, Caen 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 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: stopped early, as of the sponsor's last update on 26 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. 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 was stopped early (reason given: lack of patient). 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?
Visual Analogue Scale for pain (time frame: chenge between Day 232 - Day 0). 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 26 Jun 2026.