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Recruiting NCT06365151

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

No phase Interventional Fibromyalgia Temporomandibular Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Osteopathic manual therapy, Sham osteopathic manual therapy.
Who it may be relevant to
Registry conditions: Fibromyalgia, Temporomandibular Disorder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Osteopathic manual therapy
    osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.
  • Other Sham osteopathic manual therapy
    a sham osteopathic manual treatment without therapeutic effect

Primary outcome measures

  • catastrophizing [Time frame: From enrollment to the end of treatment at 6 weeks]
  • functional limitation [Time frame: 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]
  • pain and tinnitus [Time frame: From enrollment to the end of treatment at 6 weeks]
  • myofascial trigger points [Time frame: From enrollment to 4 weeks]
  • Range of motion [Time frame: From enrollment to 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Osteopatia i Fisioteràpia Cornellà — Cornellà de Llobregat

Identifiers

NCT: NCT06365151 · TMDs fibromyalgia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗