CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 107 enrolled
Drug / intervention
Self managementother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05426655
NCT05426655N/ACompleted

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

Jose Edgar Ferrandez Gomez·interventional·Posted Jun 22, 2022·Updated Feb 9, 2026

In Brief

A clinical study evaluating Self management for Temporomandibular Disorder and 2 related conditions. Completed, enrolled 107 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 22, 2022
Enrollment StartJun 16, 2022
Primary CompletionFeb 11, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.0 years ago

Interventions

Self managementother

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.