Additional Effect of Pain Neuroscience Education to Orofacial and Neck Exercises in Temporomandibular Disorders

University of Sao Paulo

Status: Completed

Conditions: Temporomandibular Disorders

Treatments: Other: Orofacial Manual Therapy; Other: Pain Neuroscience Education (PNE); Other: Neck Motor Control Exercises; Other: Orofacial Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT03926767

3449/2018

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups

Pain Neuroscience Education + orofacial and neck exercises

Experimental group

Description:

All participants in this arm will initially receive two additional sessions in which a workshop on PNE will be administered and discussed. A power-point presentation with metaphors and animated videos will be employed. The PNE program will be held in 2 sessions of 30 minutes each. A protocol of Orofacial Exercises and Manual Therapy will be adopted in the present study. A protocol of neck motor control protocol will be adopted in our study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will be comprised of orofacial strategies and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.

Treatment:

Other: Orofacial Exercises

Other: Neck Motor Control Exercises

Other: Pain Neuroscience Education (PNE)

Other: Orofacial Manual Therapy

Orofacial and neck exercises

Active Comparator group

Description:

A protocol of neck motor control protocol will be adopted in our study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will be comprised of orofacial strategies and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.

Treatment:

Other: Orofacial Exercises

Other: Neck Motor Control Exercises

Other: Orofacial Manual Therapy