Clinical trial NCT03926767: Additional Effect of Pain Neuroscience Education to Orofacial and Neck Exercises in Temporomandibular Disorders
Official title: Additional Effect of Pain Neuroscience Education to Orofacial Manual Therapy and Orofacial and Neck Motor Control Exercises for Pain Intensity and Disability in Temporomandibular Disorders: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Keywords: Pain Neuroscience Education
Chronic Pain
Orofacial Manual Therapy
Orofacial exercises
Neck Motor Control Exercises
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study will be to verify the additional effect of Pain Neuroscience Education program to orofacial manual therapy and orofacial and neck motor control exercises for pain intensity and disability and for the secondary outcomes pain self-efficacy, kinesiophobia, and overall perception of improvement in patients with Temporomandibular Disorders (TMD). This study will be a randomized clinical trial comprising a sample of 148 participants. Subjects will undergo a screening process to verify those presenting a diagnosis of painful TMD confirmed by the Research Diagnostic Criteria (RDC/TMD), between 18 and 55 years of both genders, and then the volunteers will be randomized into two groups (G1: Pain Neuroscience Education + Orofacial Manual Therapy/orofacial exercises/neck motor control exercises vs. G2: Orofacial Manual Therapy/orofacial exercises/neck motor control exercises). These volunteers will be recruited at the Dentistry Clinic of the University of São Paulo's School of Dentistry of Ribeirão Preto - University of São Paulo. The intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 hour per session. The primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia and overall perception of improvement. The participants will be assessed immediate after the last session and at one and three-month follow-ups.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of painful TMD Research Diagnostic Criteria for TMD (RDC/TMD)
* A history of orofacial pain at least three months prior to the study (TREEDE et al, 2015)
* age ranging between 18 to 55 years, considering the greater prevalence of TMD associated with this age period.

Exclusion Criteria:

* Patients with illiteracy, severe depression (medical diagnoses), clinical history of tumors in the craniofacial region, patients in the post dental surgery period or submitted to previous physical therapy in the past year or to any health/pain education strategy, pregnant women, infections, whiplash-associated disorders and with chronic degenerative inflammatory or neurologic disorders were excluded from this study. Patients will be instructed to not use pain relief medications during the intervention period of this trial and if any medication be used, participants will be encouraged to report.

Primary outcomes:
measure: Change in Pain intensity
timeFrame: Immediately after, one- and three-month follow-up
measure: Change in Orofacial Pain related Disability
timeFrame: Immediately after, one- and three-month follow-up
Secondary outcomes:
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Immediately after, one- and three-month follow-up
measure: Change in Kinesiophobia
timeFrame: Immediately after, one- and three-month follow-up
measure: Change in Global Perceived Improvement
timeFrame: Immediately after, one- and three-month follow-up
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Thais Chaves, PhD
role: STUDY_CHAIR
References:
citation: Aguiar ADS, Moseley GL, Bataglion C, Azevedo B, Chaves TC. Education-Enhanced Conventional Care versus Conventional Care Alone for Temporomandibular Disorders: A Randomized Controlled Trial. J Pain. 2023 Feb;24(2):251-263. doi: 10.1016/j.jpain.2022.09.012. Epub 2022 Oct 8.
citation: Dos Santos Aguiar A, Bataglion C, Felicio LR, Azevedo B, Chaves TC. Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial. Trials. 2021 Sep 6;22(1):596. doi: 10.1186/s13063-021-05532-x.