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

NCT06365151 | Recruiting

• 1 other identifier: TMDs fibromyalgia
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Temporomandibular Disorder

Keywords

temporomandibular joint disorders; fibromyalgia; Osteopathic medicine; chronic pain; musculoskeletal manipulations

Outcome Measures

Primary Outcomes (6)

• catastrophizing

  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

  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

  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

  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

  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

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

  From enrollment to 4 weeks

Study Arms (2)

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

sham

SHAM COMPARATOR

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

Interventions

Osteopathic manual therapy OTHER

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

experimental

Sham osteopathic manual therapy OTHER

a sham osteopathic manual treatment without therapeutic effect

sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

Osteopatia i Fisioteràpia Cornellà

Cornellà de Llobregat, Barcelona, 08940, Spain

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Temporomandibular Joint Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Llanos de la Iglesia

  Departament de infermeria i fisioterapia. universitat de Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Llanos de la Iglesia, MsC

CONTACT

+4679536992; llanos.delaiglesia@gmail.com

Llanos de la Iglesia

CONTACT

+34679536992; llanos.delaiglesia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 15, 2024
• Study Start: April 5, 2024
• Primary Completion: July 31, 2025
• Study Completion: April 5, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

ES (1)