An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia

NCT ID: NCT06365151

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2026-04-05

Brief Summary

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Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders.

Detailed Description

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Conditions

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Fibromyalgia Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental

treatment will be carried out following a previously validated approach algorithm.

Articulatory techniques, soft tissue mobilization techniques, trigger point inhibition, etc. will be used.

Group Type EXPERIMENTAL

Osteopathic manual therapy

Intervention Type OTHER

osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.

sham

A sham treatment will be performed following a previously validated approach algorithm.

techniques will be simulated in such a way that they will have no therapeutic effect.

Group Type SHAM_COMPARATOR

Sham osteopathic manual therapy

Intervention Type OTHER

a sham osteopathic manual treatment without therapeutic effect

Interventions

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Osteopathic manual therapy

osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.

Intervention Type OTHER

Sham osteopathic manual therapy

a sham osteopathic manual treatment without therapeutic effect

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* be diagnosed as suffering from fibromyalgia,
* present moderate pain or dysfunction of more than 3 months' duration in the temporomandibular joint,
* be over 18 years old,
* understand Spanish and/or Catalan correctly,
* and read and accept the informed consent form

Exclusion Criteria

* history of trauma or recent surgery to the head, face or neck;
* systemic, rheumatic or central nervous system diseases;
* diagnosis of malignant tumors or cancer in the orofacial region;
* participate in other studies at the same time.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitat de Lleida

OTHER

Sponsor Role lead

Responsible Party

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Llanos de la Iglesia

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Llanos de la Iglesia

Role: PRINCIPAL_INVESTIGATOR

Departament de infermeria i fisioterapia. universitat de Lleida

Locations

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Osteopatia i Fisioteràpia Cornellà

Cornellà de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Llanos de la Iglesia, MsC

Role: CONTACT

+4679536992

Llanos de la Iglesia

Role: CONTACT

+34679536992

Facility Contacts

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Llanos de la Iglesia, MsC

Role: primary

+34679536992

Other Identifiers

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TMDs fibromyalgia

Identifier Type: -

Identifier Source: org_study_id

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