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

NCT03926767 | Completed

• 1 other identifier: 3449/2018
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders

Keywords

Pain Neuroscience Education; Chronic Pain; Orofacial Manual Therapy; Orofacial exercises; Neck Motor Control Exercises

Outcome Measures

Primary Outcomes (2)

• Change in Pain intensity

  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".

  Immediately after, one- and three-month follow-up

• Change in Orofacial Pain related Disability

  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.

  Immediately after, one- and three-month follow-up

Secondary Outcomes (3)

• Change in Pain Self-Efficacy Questionnaire (PSEQ)

  Immediately after, one- and three-month follow-up

• Change in Kinesiophobia

  Immediately after, one- and three-month follow-up

• Change in Global Perceived Improvement

  Immediately after, one- and three-month follow-up

Study Arms (2)

Pain Neuroscience Education + orofacial and neck exercises

EXPERIMENTAL

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.

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

Orofacial and neck exercises

ACTIVE COMPARATOR

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.

Other: Orofacial Manual Therapy; Other: Orofacial Exercises; Other: Neck Motor Control Exercises

Interventions

Pain Neuroscience Education (PNE) OTHER

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. The intervention program will be divided into 17 thematic topics according to Explain Pain.

Pain Neuroscience Education + orofacial and neck exercises

Orofacial Manual Therapy OTHER

A protocol of Orofacial Exercises and Manual Therapy will be adopted in the present study. The manual therapy techniques will be: Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.

Orofacial and neck exercises; Pain Neuroscience Education + orofacial and neck exercises

Orofacial Exercises OTHER

Two mandibular exercises: Mandibular body-condylar cross-pressure chewing technique and Post-isometric relaxation stretches-laterotrusion and opening. Each exercise will be executed 10 times per session for 10 seconds.

Orofacial and neck exercises; Pain Neuroscience Education + orofacial and neck exercises

Neck Motor Control Exercises OTHER

A protocol of neck motor control protocol will be adopted in our study. The exercises included bracing exercises (six hierarchical levels) in neurodevelopment stages for the cervical spine. Extremity range of motion exercises will be conducted while maintaining a stable spine at the specific positions. Also, cervical isometric exercises (five hierarchical levels) will be carried out directly forward, obliquely, toward right and left, and directly backward by maintaining a stable spine with elastic resistive bands. Finally, exercises also included functional training with elastic resistance and exercise balls on unstable surfaces (eight hierarchical levels). The criteria to progress in each exercise domain (bracing, isometric exercises or functional training) will be sustain the contraction for 10 seconds, 10 times.

Orofacial and neck exercises; Pain Neuroscience Education + orofacial and neck exercises

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 36220481 DERIVED

• 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.

  PMID: 34488856 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thais Chaves, PhD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

Study Record Dates

• First Submitted: April 21, 2019
• First Posted: April 24, 2019
• Study Start: May 10, 2019
• Primary Completion: October 30, 2020
• Study Completion: February 28, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)