Myofascial Pain syndrome
Conditions
Interventions
This is a clinical trial with a parallel intervention design, with 2 arms, double-blind masking and allocation by controlled randomization. For allocation, participants were randomly assigned by simpl
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H02.004
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adults aged 18 to 60 years with a diagnosis of temporomandibular muscle dysfunction, masticatory myofascial pain, according to the Research Diagnostic Criteria for Temporomandibular Disorders; pain of intensity 4 or higher measured by visual analogue scale; pain for at least 3 months; possibility of attending appointments during the treatment and evaluation period
Exclusion criteria
Exclusion criteria: History of facial trauma; pregnancy; acuphobia; continuous use of nonsteroidal anti-inflammatory drugs, analgesics, antidepressants or muscle relaxants; intracranial, neurological and other major causes of headache disorders; other causes of orofacial pain; temporomandibular joint arthralgia; being submitted to another type of treatment for temporomandibular disorders; diagnosis of fibromyalgia; edentulism; use of complete denture; non-acceptance to voluntarily participate in the research or refusal to sign the free and informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed outcome 1 (pain intensity) - Pain intensity, measured by the Visual Analog Scale with 0 = no pain and 10 worst imaginable pain, occurred in at least 25%. Pain, assessed by the short version of the McGill Pain Questionnaire, decreases by at least 25% in the final score (ranging from 0 to 45 points) ;Expected outcome 1 (pain intensity) - Check if the intensity of pain, measured by the Visual Analog Scale (where 0 = no pain and 10 is the worst pain imaginable) and by the McGill Pain Questionnaire ((which ranges from 0 to 45 points), decreases by at least 25% ;Expected outcome 2 (mandibular function) - Mandibular function, measured by the Craniomandibular Clinical Dysfunction Index, should have a decrease of at least 1 point in the final score. Mandibular function, as measured by the Manchester Orofacial Pain Disability Scale and Mandibular Functional Limitation Index, should have a decrease greater than or equal to 15% in the final scores;Observed outcome 2 (mandibular function) - Mandibular function, measured by the Craniomandibular Clinical Dysfunction Index, had a decrease of at least 1 point in the final score. Mandibular function, as measured by the Manchester Orofacial Pain Disability Scale and Mandibular Functional Limitation Index, had a decrease greater than or equal to 15% in the final scores ;Expected outcome 3 (quality of life) - Quality of life, measured by the Short Form 36 Health Survey instruments and the Oral Health Impact Profile, should improve with difference greater than or equal to 15% ;Observed outcome 3 (quality of life) - Quality of life, measured by the Short Form 36 Health Survey instruments and the Oral Health Impact Profile, improved, with difference greater than or equal to 15% | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 4 (anxiety) - Anxiety, measured by the Hospital Anxiety and Depression Scale, should have a decrease greater than or equal to 15% in the specific anxiety score of the scale ;Observed outcome 4 (anxiety) - Anxiety, measured by the Hospital Anxiety and Depression Scale, had a decrease greater than or equal to 15% in the specific anxiety score of the scale ;Expected outcome 5 (depression) - Depression, as measured by the Beck Depression Inventory, should decrease by at least 15% ;Observed outcome 5 (depression) - Depression, as measured by the Beck Depression Inventory, decreased by at least 15%;Expected outcome 6 (sleep disorders) - It is expected a decrease in sleep disorders greater than or equal to 15% through the Pittsburgh Sleep Quality Index;Observed outcome 6 (sleep disorders) - There was a decrease in sleep disorders greater than or equal to 15% through the Pittsburgh Sleep Quality Index;Expected outcome 7 (stress) - It is expected a decrease in stress greater than or equal to 15% through the Perceived Stress Scale;Observed outcome 7 (stress) - There was a decrease in stress greater than or equal to 15% through the Perceived Stress Scale;Expected outcome 8 (pain catastrophizing) - It is expected a decrease greater than or equal to 15% in central sensitization, measured by the Pain Catastrophizing Scale;Observed outcome 8 (pain catastrophizing) - There was a decrease greater than or equal to 15% in central sensitization, measured by the Pain Catastrophizing Scale | — |
Countries
Brazil
Contacts
Public ContactCamila Megale de Almeida Leite
Universidade Federal de Minas Gerais
Outcome results
None listed