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Effect of Pain Education associated with Cyclobenzaprine in patients with Masticatory Muscular Pain: a clinical trial

Effect of Neuroscience-based Pain Education associated with Cyclobenzaprine administration in patients with Masticatory Myofascial Pain: a double blind randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9yy8w2k
Enrollment
Unknown
Registered
2023-08-11
Start date
2022-11-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transtornos da Articulação Temporomandibular

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. Participants are assigned to intervention groups using a probability-based method (computer-generated random sequence). Experimen
I02.233.332

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women; aged 18 to 60 years; diagnosed with muscular temporomandibular disorder or masticatory myofascial pain according to the Diagnostic Criteria for Temporomandibular Disorders; pain greater than or equal to 4 on the Visual Numerical Scale for at least 3 months

Exclusion criteria

Exclusion criteria: History of recent facial trauma within the past 2 years; gestation; continuous use of non-steroidal anti-inflammatory drugs, analgesics, antidepressants or muscle relaxants; intracranial, neurological disorders and other major causes of headache; odontogenic pain; persistent idiopathic dentoalveolar pain; orthodontics; other current treatment for temporomandibular disorders; diagnosis of fibromyalgia; hypersensitivity to cyclobenzaprine or any other component of the product's formula; any contraindication provided in the package insert for the use of cyclobenzaprine; non-acceptance to voluntarily participate in the research or refusal to sign the informed consent form

Design outcomes

Primary

MeasureTime frame
Decrease in pain intensity measured by the Visual Numeric Scale equal to or greater than 20 percent;Improvement in mandibular function measured by Jaw Functional Limitation Scale and Graded Chronic Pain Scale equal to or greater than 20 percent—

Secondary

MeasureTime frame
Improvement in quality of life measured by Medical Outcomes Study 36-Item Short-Form Health Survey equal to or greater than 20 percent;Decrease in central sensitization measured by Central Sensitization Inventory equal to or greater than 20 percent ;Decrease in anxiety symptoms measured by Generalized Anxiety Disorder 7 equal to or greater than 20 percent ;Decrease in depressive symptoms measured by Patient Health Questionnaire 9 equal to or greater than 20 percent ;Decrease in sleep quality measured by Pittsburgh Sleep Quality Index equal to or greater than 20 percent ;Decrease in somatization measured by Patient Health Questionnaire 15 equal to or greater than 20 percent ;Decrease in kinesiophobia measured by Tampa Scale for Kinesiophobia equal to or greater than 20 percent ;Decrease in pain catastrophizing measured by Pain catastrophizing Scale equal to or greater than 20 percent ;Improvement in pain self-efficacy measured by Chronic Pain Self-efficacy Scale equal to or greater than 20 percent Chronic Pain Self-efficacy Scale—

Countries

Brazil

Contacts

Public ContactFranklin Teixeira de Salles Neto

Universidade Federal de Minas Gerais

franklintsneto@gmail.com+55-31-991971112

Outcome results

None listed

Source: REBEC (via WHO ICTRP)