Fibromyalgia SyndromeFIBROPATHICNCT02343237
Osteopathic Medicine in Fibromyalgia Syndrome
A study testing Osteopathic treatment and Factitious osteopathic treatment in people with Fibromyalgia Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Osteopathic treatment and Factitious osteopathic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2015to 27 Jul 2018
- 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
- Patient Male or female aged at least of 18
- Patient with fibromyalgia, according to the American College of Rheumatology (ACR) 1990 criteria, with a global level of pain of 50 over a 100 mm EVA scale
- Patient suffering from fibromyalgia for over a year
- Patient with stable medical/non medical treatment for at least 1 month before the recruitment
- Patient referred to a medical center for a multidisciplinary approach
- Patient who can be followed for at least 12 months after the end of the osteopathic sessions
- Patient giving his informed consent to participate in the study
- Patient affiliated to or beneficiary of social insurance
Who cannot join
- Treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine)
- Unability to attend 6 sessions, meaning one weekly session, of osteopathy, at Hôtel Dieu
- Severe psychiatric pathology : major depression, psychosis
- Pregnancy or breast feeding
- The patient is already included in another clinical study
- Patient under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome
The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.
Read the detailed description
An osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia.
This technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension.
This is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. The purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. It includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months.
The primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (EVA).
The secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations.
This study will also allow to identify the profile of the osteopathic treatment responders patients
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Osteopathic treatment, Factitious osteopathic treatment
- Keywords
- Fibromyalgia syndrome, pain, quality of life, osteopathic treatment
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentProcedure or surgery
osteopathic sessions of 20 minutes
Factitious osteopathic treatmentProcedure or surgery
6 factitious osteopathic sessions of 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Osteopathy + | Experimental | 75 patients will make 6 osteopathic sessions Receives: Procedure: Osteopathic treatment |
| Osteopathy - | Active comparator | 75 patients will make 6 factitious osteopathic sessions Receives: Procedure: Factitious osteopathic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain during the 6 weeks of osteopathic treatment
The assessment will be on the declarative of the patient. He will report every week the intensity of pain measured by a numeric scale (0 to 100).
Measured: 6 weeks
Secondary outcomes (12)
Quality of life
Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey)
Measured: 6 weeks after osteopathic treatment
Quality of life
Questionnaires: FIQ and SF-36
Measured: 3 months after osteopathic treatment
Quality of life
Questionnaires: FIQ and SF-36
Measured: 6 months after osteopathic treatment
Quality of life
Questionnaires: FIQ and SF-36
Measured: 1 year after osteopathic treatment
Fatigue
Questionnaires: multidimensional fatigue inventory (MFI) scale
Measured: 6 weeks after osteopathic treatment
Fatigue
Questionnaires: MFI scale
Measured: 3 months after osteopathic treatment
Fatigue
Questionnaires: MFI scale
Measured: 6 months after osteopathic treatment
Fatigue
Questionnaires: MFI scale
Measured: 1 year after osteopathic treatment
Pain
Questionnaires: Brief Pain Inventory (BPI)
Measured: 6 weeks after osteopathic treatment
Pain
Questionnaires: BPI
Measured: 3 months after osteopathic treatment
Pain
Questionnaires: BPI
Measured: 6 months after osteopathic treatment
Pain
Questionnaires: BPI
Measured: 1 year after osteopathic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start2 Dec 2015
- Primary completion20 Jul 2017
- Study completion27 Jul 2018
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 Fibromyalgia SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Serge PERROT, PU-PH, Principal investigator, + 33 1.42.34.84.49
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343237
- Sponsor's protocol ID
- P130605
- Acronym
- FIBROPATHIC
- Status last verified
- Aug 2025
- First submitted
- 15 Jan 2015
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Coste J, Medkour T, Maigne JY, Perez M, Laroche F, Perrot S. Osteopathic medicine for fibromyalgia: a sham-controlled randomized clinical trial. Ther Adv Musculoskelet Dis. 2021 Apr 16;13:1759720X211009017. doi: 10.1177/1759720X211009017. eCollection 2021.
PubMed 33948127
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Study, Against Credible Factitious Intervention That Evaluates the Interest of Osteopathic Medicine in the Management of Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT02343237
- Acronym / sponsor ID
- FIBROPATHIC / P130605
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia syndrome, pain, quality of life, osteopathic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 21 Jan 2015 (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.
The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.
Detailed description
An osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia.
This technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension.
This is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. The purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. It includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months.
The primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (EVA).
The secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations.
This study will also allow to identify the profile of the osteopathic treatment responders patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathy + | Experimental | Procedure: Osteopathic treatment75 patients will make 6 osteopathic sessions |
| Osteopathy - | Active comparator | Procedure: Factitious osteopathic treatment75 patients will make 6 factitious osteopathic sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient Male or female aged at least of 18
- Patient with fibromyalgia, according to the American College of Rheumatology (ACR) 1990 criteria, with a global level of pain of 50 over a 100 mm EVA scale
- Patient suffering from fibromyalgia for over a year
- Patient with stable medical/non medical treatment for at least 1 month before the recruitment
- Patient referred to a medical center for a multidisciplinary approach
Key exclusion criteria (6 listed)
- Treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine)
- Unability to attend 6 sessions, meaning one weekly session, of osteopathy, at Hôtel Dieu
- Severe psychiatric pathology : major depression, psychosis
- Pregnancy or breast feeding
- The patient is already included in another clinical 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 treatmentosteopathic sessions of 20 minutes | Procedure or surgery | Osteopathy + |
| Factitious osteopathic treatment6 factitious osteopathic sessions of 20 minutes | Procedure or surgery | Osteopathy - |
Primary outcome
Evaluation of pain during the 6 weeks of osteopathic treatment
Time frame: 6 weeks
The assessment will be on the declarative of the patient. He will report every week the intensity of pain measured by a numeric scale (0 to 100).
12 secondary outcomes
Quality of life
Time frame: 6 weeks after osteopathic treatment
Quality of life
Time frame: 3 months after osteopathic treatment
Quality of life
Time frame: 6 months after osteopathic treatment
Quality of life
Time frame: 1 year after osteopathic treatment
Fatigue
Time frame: 6 weeks after osteopathic treatment
Fatigue
Time frame: 3 months after osteopathic treatment
Fatigue
Time frame: 6 months after osteopathic treatment
Fatigue
Time frame: 1 year after osteopathic treatment
Pain
Time frame: 6 weeks after osteopathic treatment
Pain
Time frame: 3 months after osteopathic treatment
Pain
Time frame: 6 months after osteopathic treatment
Pain
Time frame: 1 year after osteopathic treatment
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 5 Sep 2025.
- Results publication: PubMed 33948127Coste J, Medkour T, Maigne JY, Perez M, Laroche F, Perrot S. Osteopathic medicine for fibromyalgia: a sham-controlled randomized clinical trial. Ther Adv Musculoskelet Dis. 2021 Apr 16;13:1759720X211009017. doi: 10.1177/1759720X211009017. eCollection 2021.
- 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.
Serge PERROT, PU-PH principal investigator
+ 33 1.42.34.84.49
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment and Factitious osteopathic treatment in people with Fibromyalgia Syndrome, 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 8 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 5 Sep 2025. 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 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?
Evaluation of pain during the 6 weeks of osteopathic treatment (time frame: 6 weeks). 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 NCT02343237, 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 5 Sep 2025.