Clinical trial NCT05426655: Effects of a Self-management Program for Temporomandibular Myalgia in Subjects With Fibromyalgia: a Single Arm Study
Official title: Effects of a Self-management Program for Temporomandibular Myalgia in Subjects With Fibromyalgia: a Single Arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Disorder
Fibromyalgia
Self Management
Keywords: self-management
self-care
pain neuroscience education
temporomandibular disorder
fibromyalgia
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Analytical, prospective experimental study: uncontrolled clinical trial.
Primary purpose: TREATMENT

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.

Detailed description: Study design Analytical, prospective experimental study: uncontrolled clinical trial.

Population and study sample The study sample will be made up of subjects diagnosed with fibromyalgia who present with local myalgia, myofascial pain or referred myofascial pain in the temporomandibular region, according to the diagnostic criteria (DC/TMD). The subjects will be recruited after the mandatory acceptance and authorization by the corresponding bodies, during a recruitment period of approximately eight weeks, through different associations of fibromyalgia patients.

Intervention In a first visit, demographic data will be recorded and an examination will be performed to assess the presence of local myalgia, myofascial pain or referred myofascial pain in the temporomandibular region, according to the diagnostic criteria (DC/TMD). You will also be given, to read and sign, the informed consent for participation in the study, as well as the data protection document. After this visit, the defined eligibility criteria (inclusion and exclusion) will be applied.

In a second visit, a preliminary assessment will be carried out that will consist of 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.

One week later, the intervention program will begin. The program will consist of 3 online sessions (visits 3, 4 and 5) 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.

On a sixth visit, 4 weeks after the end of the program, a new measurement and assessment will be taken. This measurement will be very similar to the one performed on the second visit, except for 1 variable: the patient's expectations will not be recorded, and the patient's satisfaction with the treatment received will be recorded. The objective will be to record the changes produced after the application of the treatment program.

On a seventh visit, at 6 months (medium-term follow-up), all the measurements and assessments made on the sixth visit will be repeated, with the aim of recording their status after six months.

At an eighth visit, at 12 months (long-term follow-up), all the measurements and assessments made at the seventh visit will be repeated, with the aim of recording their status after twelve months.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from the Baseline in the Oral Health-Related Quality of Life (OHRQoL)
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Secondary outcomes:
measure: Change from the Baseline in the Fear of temporomandibular movement (kinesiophobia)
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Baseline in pain maladaptation
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Baseline in symptoms related to central sensitization
timeFrame: Baseline, 4 weeks after the end of the intervention at month 6, at month 12.
measure: Change from the Baseline in self-efficacy expectations
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Baseline in pain coping strategies
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Pain intensity
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Baseline in the functional status of the masticatory system
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Baseline in sleep difficulties
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Baseline in emotional state
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the Baseline in oral behaviors
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Change from the knowledge about neurophysiology of pain and conceptualization of pain
timeFrame: Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
measure: Treatment expectations
timeFrame: Pre-intervention
measure: Degree of satisfaction with the intervention
timeFrame: 4 weeks after the end of the intervention
measure: Adverse effects
timeFrame: 4 weeks after the end of the intervention
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Fibrofamur
Study officials:
affiliation: Universidad de Murcia
name: J. Édgar Ferrández-Gómez
role: PRINCIPAL_INVESTIGATOR
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