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

August 27, 2025 updated by: Llanos de la Iglesia, Universitat de Lleida

Effectiveness of an Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Cornellà de Llobregat, Barcelona, Spain, 08940
        • Recruiting
        • Osteopatia i Fisioteràpia Cornellà
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Osteopathic manual therapy
osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.
Sham Comparator: 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.
Other: Sham osteopathic manual therapy
a sham osteopathic manual treatment without therapeutic effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
catastrophizing
Time Frame: From enrollment to the end of treatment at 6 weeks
The Pain Catastrophizing scale (PCS), evaluates the degree og catastrophic thinking gdue to pain.It is a 13-item scale, with a total range from 0 to 52. Higher scores are associated with a greater degree of pain catastrophizing.
From enrollment to the end of treatment at 6 weeks
functional limitation
Time Frame: From enrollment to the end of treatment at 6 weeks
evaluated with tue short version of the Jaw functional limitation scale (JFLS-8). Evaluates the functional status of the masticatory system. Questionnaire with 8 items, each with a scale from 0 to 10. A higher score suggests a greater limitation.
From enrollment to the end of treatment at 6 weeks
functional status, disability and pain
Time Frame: From enrollment to the end of treatment at 6 weeks
collected in the craniofacial pain and disability inventory (CFPDI). Self administered questionnaire of 21 items. Each item is scored on a Likert scale from 0 to 3.
From enrollment to the end of treatment at 6 weeks
pain and tinnitus
Time Frame: From enrollment to the end of treatment at 6 weeks
evaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable.
From enrollment to the end of treatment at 6 weeks
myofascial trigger points
Time Frame: From enrollment to 4 weeks
presence of a palpable tight band, presence of a hyperirritable tenderpoint within te tight band, local twitch response elicited by acute palpation of the tight band, and presence refered pain in response ot trigger point compression.
From enrollment to 4 weeks
Range of motion
Time Frame: From enrollment to 4 weeks
measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.
From enrollment to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Lleida

Investigators

  • Principal Investigator: Llanos de la Iglesia, Departament de infermeria i fisioterapia. universitat de Lleida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Actual)

July 31, 2025

Study Completion (Estimated)

April 5, 2026

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMDs fibromyalgia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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