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NCT Number: NCT06365151

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.

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Key information

Conditions

Fibromyalgia Chronic Pain Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Stomatognathic Diseases Temporomandibular Disorder Temporomandibular Joint Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osteopatia i Fisioteràpia Cornellà

Cornellà de Llobregat, Barcelona, 08940, Spain

Location status: Recruiting

Location contact

Llanos de la Iglesia, MsC

CONTACT

[email protected]

+34679536992

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteopathic manual therapy

Other

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

Sham osteopathic manual therapy

Other

a sham osteopathic manual treatment without therapeutic effect

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Range of motion

    Time frame: From enrollment to 4 weeks

    measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization.

Study contacts

Contact information is provided by the study sponsor or research team.

Llanos de la Iglesia

CONTACT

[email protected]

+34679536992

Llanos de la Iglesia, MsC

CONTACT

[email protected]

+4679536992

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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