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

Primary Purpose

Temporomandibular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pain Neuroscience Education (PNE)
Orofacial Manual Therapy
Orofacial Exercises
Neck Motor Control Exercises
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders focused on measuring Pain Neuroscience Education, Chronic Pain, Orofacial Manual Therapy, Orofacial exercises, Neck Motor Control Exercises

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Neuroscience Education + orofacial and neck exercises

Orofacial and neck exercises

Arm 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.

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.

Outcomes

Primary Outcome Measures

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".
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.

Secondary Outcome Measures

Change in Pain Self-Efficacy Questionnaire (PSEQ)
Study participants will be evaluated on self-efficacy related to chronic pain, which can be defined as an individual's confidence he/she can successfully produce desirable results related to living with chronic pain. The PSEQ has 10 items which are rated on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident"). It was adapted and validated to Brazilian Portuguese (Sarda et al, 2007). Previous research showed an effect on self-efficacy using a PNE intervention based on metaphors compared to an intervention using cognitive-behavioral concepts.
Change in Kinesiophobia
The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK/TMD) is self-report questionnaire that assesses the fear of movement. In this study, the TSK-TMD with 12 items validated in Brazilian Portuguese was used and showed acceptable psychometric measurements. Each item is scored on a 4-point ordinal scale, ranging from 'strongly disagree' (score = 1) to 'strongly agree' (score = 4). Ratings are summed to yield a total score. Higher scores reflect a greater fear of movement (12-48 points).
Change in Global Perceived Improvement
The global perceived effect (GPE) used for this trial is an 11-point scale that ranges from -5 ("vastly worse") through 0 ("no change") to +5 ("completely recovered") and participants are asked: "Compared to when this episode first started, how would you describe your back these days?". A higher score indicates higher perception of recovery from the condition.

Full Information

First Posted
April 21, 2019
Last Updated
November 3, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03926767
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders
Keywords
Pain Neuroscience Education, Chronic Pain, Orofacial Manual Therapy, Orofacial exercises, Neck Motor Control Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education + orofacial and neck exercises
Arm Type
Experimental
Arm 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.
Arm Title
Orofacial and neck exercises
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education (PNE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Orofacial Manual Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Orofacial Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neck Motor Control Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain intensity
Description
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".
Time Frame
Immediately after, one- and three-month follow-up
Title
Change in Orofacial Pain related Disability
Description
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.
Time Frame
Immediately after, one- and three-month follow-up
Secondary Outcome Measure Information:
Title
Change in Pain Self-Efficacy Questionnaire (PSEQ)
Description
Study participants will be evaluated on self-efficacy related to chronic pain, which can be defined as an individual's confidence he/she can successfully produce desirable results related to living with chronic pain. The PSEQ has 10 items which are rated on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident"). It was adapted and validated to Brazilian Portuguese (Sarda et al, 2007). Previous research showed an effect on self-efficacy using a PNE intervention based on metaphors compared to an intervention using cognitive-behavioral concepts.
Time Frame
Immediately after, one- and three-month follow-up
Title
Change in Kinesiophobia
Description
The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK/TMD) is self-report questionnaire that assesses the fear of movement. In this study, the TSK-TMD with 12 items validated in Brazilian Portuguese was used and showed acceptable psychometric measurements. Each item is scored on a 4-point ordinal scale, ranging from 'strongly disagree' (score = 1) to 'strongly agree' (score = 4). Ratings are summed to yield a total score. Higher scores reflect a greater fear of movement (12-48 points).
Time Frame
Immediately after, one- and three-month follow-up
Title
Change in Global Perceived Improvement
Description
The global perceived effect (GPE) used for this trial is an 11-point scale that ranges from -5 ("vastly worse") through 0 ("no change") to +5 ("completely recovered") and participants are asked: "Compared to when this episode first started, how would you describe your back these days?". A higher score indicates higher perception of recovery from the condition.
Time Frame
Immediately after, one- and three-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aroldo Aguiar, MSc
Phone
+5516981574722
Email
aroldoaguiar@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thais Chaves, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais C Chaves, PhD
Phone
55 016 3315 4413
Email
chavestc@fmrp.usp.br
First Name & Middle Initial & Last Name & Degree
Aroldo AG Aguiar, Doctor
Phone
55 16 98157.4722
Email
aroldone@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36220481
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.
Results Reference
derived
PubMed Identifier
34488856
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.
Results Reference
derived

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

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