Effects of a Self-management Program for Temporomandibular Myalgia in Subjects With Fibromyalgia: a Single Arm Study

NCT05426655 | Completed

• 1 other identifier: EFG012022
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia is one of the most prevalent chronic widespread pain entities today. One of the most common problems in patients with fibromyalgia are alterations of the temporomandibular region, present in approximately 80% of the subjects, being, in turn, alterations of muscular origin the most common with a prevalence of 84%. One of the most promising therapeutic strategies is one that leads to self-management by the patient. The main objective of this study is to analyze the effect of a self-management program for myalgia in the temporomandibular region in subjects with fibromyalgia. For this, an experimental study of the uncontrolled Clinical Trial type will be carried out. Participants must be over 18 years of age, have a diagnosis of fibromyalgia and have myalgia or myofascial pain syndrome in the temporomandibular region. Demographic data, mandibular function, pain level, quality of life related to oral health, kinesiophobia, anxiety and depression, sleep, patient oral habits, catastrophizing, knowledge about pain, central sensitization, self-efficacy, coping with pain patient expectations, and patient satisfaction with the treatment received. An initial data collection will be carried out. The intervention will be carried out in 3 online sessions in which different pain processes will be explained, mandibular mobility exercises, masticatory muscle self-massage, as well as recommendations and advice on its pathology. Data will be collected again 4 weeks after the end of the program and at months 6 and 12. The appearance of adverse effects linked to the therapeutic program is not contemplated.

Conditions

Temporomandibular Disorder; Fibromyalgia; Self Management

Keywords

self-management; self-care; pain neuroscience education; temporomandibular disorder; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change from the Baseline in the Oral Health-Related Quality of Life (OHRQoL)

  Spanish version of Oral Health Impact Profile 5 items (OHIP-5 items).Responses are presented on a 5-point ordinal scale (0, never; 1, hardly ever; 2, occasionally; 3, fairly often; and 4, very often). Summing all responses resulted in a score ranging from a minimum of 0 to a maximum of 20. A larger score indicated more negative impacts of oral health problems.

  Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

Secondary Outcomes (14)

• Change from the Baseline in the Fear of temporomandibular movement (kinesiophobia)

  Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

• Change from the Baseline in pain maladaptation

  Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

• Change from the Baseline in symptoms related to central sensitization

  Baseline, 4 weeks after the end of the intervention at month 6, at month 12.

• Change from the Baseline in self-efficacy expectations

  Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

• Change from the Baseline in pain coping strategies

  Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.

Study Arms (1)

Self management

EXPERIMENTAL

Intervention group: education in pain neuroscience + self-massage + exercises + advice and recommendations.

Other: Self management

Interventions

Self management OTHER

The program will consist of 3 sessions in which everything related to pain and its management will be explained. In a first workshop, a first educational session on the neurophysiology of pain will be given by means of a Power Point presentation. In a second workshop, a tool will be used to locate those factors that can improve/worse the pain, physical documentation will be delivered with instructions for performing a self-massage and exercises of the temporomandibular region as well as advice and recommendations to manage different situations that may appear on a daily basis and on Lifestyle. A meditation session will also be held. In the third and last workshop, the game "the painometer" will be played and a meditation session will be held.

Self management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years old.
• Subjects diagnosed with fibromyalgia.
• Orofacial pain of at least 3 months of evolution (considered chronic, according to IASP).
• Presence of myalgia, local myalgia, myofascial pain or referred myofascial pain in the temporomandibular region (according to DC/TMD).

You may not qualify if:

• Internal temporal-romandibular joint disorder with anterior disc displacement, joint pathology (arthritis), facial paralysis (active), mandibular fracture (active), infectious-inflammatory picture of odontogenic origin (active).
• Pregnancy.
• Neuropsychiatric pathologies (schizophrenia, bipolarity, cognitive alteration).
• Subjects receiving any other physiotherapy treatment in the mandibular region.

Sponsors & Collaborators

• Jose Edgar Ferrandez Gomez: lead

Study Sites (1)

Fibrofamur

Murcia, Murcia, Spain

Location

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MeSH Terms

Conditions

Temporomandibular Joint Disorders; Fibromyalgia

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• J. Édgar Ferrández-Gómez

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Analytical, prospective experimental study: uncontrolled clinical trial.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 22, 2022
• Study Start: June 16, 2022
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)