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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Temporomandibular Disorders
- Sponsor
- University of Sao Paulo
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Change in Pain intensity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Thais Cristina Chaves
Professor PhD
University of Sao Paulo
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.
Outcomes
Primary Outcomes
Change in Pain intensity
Time Frame: Immediately after, one- and three-month follow-up
The Numerical Pain Rating Scale will be used to assess pain intensity in this trial and consists in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Change in Orofacial Pain related Disability
Time Frame: Immediately after, one- and three-month follow-up
The Craniofacial Pain and Disability Inventory (CF-PDI) is a self-administered questionnaire that measures the outcomes of pain and disability related to craniofacial pain and demonstrated a good structure, internal consistency, reproducibility, and construct validity. Also, the Brazilian Portuguese version showed acceptable psychometric measurements. It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.
Secondary Outcomes
- Change in Pain Self-Efficacy Questionnaire (PSEQ)(Immediately after, one- and three-month follow-up)
- Change in Global Perceived Improvement(Immediately after, one- and three-month follow-up)
- Change in Kinesiophobia(Immediately after, one- and three-month follow-up)