NCT02343237

Brief Summary

The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

December 2, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

January 15, 2015

Last Update Submit

August 29, 2025

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia syndromepainquality of lifeosteopathic treatment

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 weeks

Secondary Outcomes (12)

  • Quality of life

    6 weeks after osteopathic treatment

  • Quality of life

    3 months after osteopathic treatment

  • Quality of life

    6 months after osteopathic treatment

  • Quality of life

    1 year after osteopathic treatment

  • Fatigue

    6 weeks after osteopathic treatment

  • +7 more secondary outcomes

Study Arms (2)

Osteopathy +

EXPERIMENTAL

75 patients will make 6 osteopathic sessions

Procedure: Osteopathic treatment

Osteopathy -

ACTIVE COMPARATOR

75 patients will make 6 factitious osteopathic sessions

Procedure: Factitious osteopathic treatment

Interventions

Osteopathic treatmentPROCEDURE

osteopathic sessions of 20 minutes

Osteopathy +
Factitious osteopathic treatmentPROCEDURE

6 factitious osteopathic sessions of 20 minutes

Osteopathy -

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel-Dieu Hospital

Paris, Île-de-France Region, 75004, France

Location

Related Publications (1)

  • 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.

    PMID: 33948127BACKGROUND

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Serge PERROT, PU-PH

    + 33 1.42.34.84.49

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 21, 2015

Study Start

December 2, 2015

Primary Completion

July 20, 2017

Study Completion

July 27, 2018

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)