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

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

Sponsors

Lead Sponsor: Jose Edgar Ferrandez Gomez

Source Universidad de Murcia
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, maximum oral opening and mandibular function, pressure pain threshold and pain level, quality of life related to oral health, kinesiophobia, anxiety and depression, sleep, patient expectations, patient satisfaction with the treatment received, patient habits, catastrophizing, knowledge about pain, central sensitization, self-efficacy, and coping with pain. An initial data collection will be carried out. The intervention will be carried out in 3 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 measuring the maximum oral opening with and without pain, pressure pain threshold in the temporomandibular joint and masseter and temporal muscles, and the level of pain in the temporomandibular joint. In addition, the subject will have to fill out a questionnaire on different aspects such as jaw function, quality of life related to oral health, kinesiophobia, anxiety and depression, sleep, patient expectations, patient habits, catastrophizing, knowledge about pain, central sensitization , self-efficacy, and coping with pain. One week later, the intervention program will begin. The program will consist of 3 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.

Overall Status Recruiting
Start Date 2022-06-16
Completion Date 2024-03-01
Primary Completion Date 2023-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from the Baseline in the Oral Health-Related Quality of Life (OHRQoL) Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Change from the Baseline in the functional status of the masticatory system Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
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.
Secondary Outcome
Measure Time Frame
Change from the Baseline in the Range of Motion of the Temporomandibular Joint Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Change from the Baseline in the Pain Pressure Threshold 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.
Change from the Baseline in sleep difficulties Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Change from the Baseline in emotional state 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 oral behaviors 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 Pain intensity Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Change from the knowledge about neurophysiology of pain and conceptualization of pain Baseline, 4 weeks after the end of the intervention, at month 6, at month 12.
Treatment expectations Pre-intervention
Degree of satisfaction with the intervention 4 weeks after the end of the intervention
Enrollment 40
Condition
Intervention

Intervention Type: Other

Intervention Name: Self management

Description: 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.

Arm Group Label: Self management

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 disorders of the temporomandibular joint with anterior disc displacement, degenerative joint pathology, dentofacial deformities, facial paralysis, history of jaw trauma, vascular pathology, history of infectious-inflammatory conditions of odontogenic origin. - Pregnancy. - Neuropsychiatric pathologies (schizophrenia, bipolarity, cognitive alteration). - Subjects receiving any other physiotherapy treatment in the mandibular region.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
J. Édgar Ferrández-Gómez Principal Investigator Universidad de Murcia
Overall Contact

Last Name: J. Édgar Ferrández-Gómez

Phone: +34663063594

Email: [email protected]

Location
Facility: Status: Contact: FIBROFAMUR (Asociación fibromialgia de Murcia) 688921300
Location Countries

Spain

Verification Date

2022-06-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Universidad de Murcia

Investigator Full Name: Jose Edgar Ferrandez Gomez

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Self management

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Analytical, prospective experimental study: uncontrolled clinical trial.

Primary Purpose: Treatment

Masking: None (Open Label)

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