Effect of Different Dosages of Pain Education Associated With Conventional Treatment for Temporomandibular Disorders

February 6, 2024 updated by: Thais Chaves, Universidade Federal de Sao Carlos

Effect of Administration of Pain Neuroscience Education at Different Dosages Associated With Conventional Treatment for Temporomandibular Disorders: a Randomized Controlled Trial

Temporomandibular Disorders (TMD) are a collection of musculoskeletal disorders which affect the masticatory structures and have a multifactorial etiology. A biopsychosocial approach is recommended for the management of these disorders including different interventions like exercise, manual therapy and pain education. The aim of this study is to compare the effect of a condensed dosage pain neuroscience education program (2 initial sessions of 60 minutes) versus a fragmented dosage format (8 sessions of 15 minutes) combined with manual therapy and orofacial exercises on primary outcomes - pain intensity and disability - and secondary outcomes - pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing - in patients with chronic painful TMD. This study will be a randomized controlled trial with a sample of 148 participants. Individuals will undergo a screening process to identify those with TMD diagnosis according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), aged 20 to 60 years, of both genders, and then the volunteers will be randomized into two groups (G1: Condensed dosage pain neuroscience education program + Manual therapy/orofacial and cervical exercises vs. G2: fragmented dosage pain neuroscience education program + Manual therapy/orofacial and cervical exercises). These volunteers will be recruited in the city of São Carlos, SP. The intervention will take place twice a week for 8 weeks, administered by a single therapist, each session lasting 1 hour. The primary outcomes will be pain intensity and disability, assessed using the numerical pain rating scale and the Craniofacial Pain and Disability Inventory (CFP-DI), respectively, and the secondary outcomes will be pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing, assessed using the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD), Global Perceived Effect of Improvement scale, Pain Self-Efficacy Questionnaire (PSEQ), CARE Empathy Scale, and Pain Catastrophizing Scale (PCS). For statistical analysis, a mixed-model effect considering time and groups as factors will be used. A significance level of p<0.05 will be considered.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13565-905
        • Federal University of São Carlos - Department of Physical Therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age between 20 and 60 years;
  • painful TMD (confirmed by applying DC/TMD);
  • complaint of pain with a minimum intensity of 3 (on a scale of 0 to 10) present for at least 3 months;
  • fluency to speak and understand Brazilian Portuguese (Mini Cog instrument to assess cognitive capacity and the Cloze Test to certify textual reading comprehension)

Exclusion Criteria:

  • history of tumors in the orofacial region;
  • central and peripheral neurological diseases;
  • uncontrolled psychiatric illnesses;
  • pregnant women;
  • presence of toothache, neuralgia or chronic painful conditions in the head region, orofacial region or systemic pain (for example, fibromyalgia, osteoarthritis, osteoarthritis or rheumatological diseases);
  • report of previous major surgeries in the craniofacial region, such as orthognathic surgeries, TMJ surgeries, or resulting from post-trauma corrections;
  • history of major trauma involving the cervical or craniofacial region (facial trauma, whiplash injuries, etc.);
  • individuals undergoing physiotherapeutic treatment up to 6 months before the start of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fragmented Pain Neuroscience Education + Manual Therapy + Orofacial and Neck Exercises
All participants in this arm will initially receive eight 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 8 sessions of 15 minutes each. Two protocols of Orofacial Exercises and Manual Therapy and of Neck Motor Control will be adopted in the present 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 consist of orofacial therapy and exercises and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.
Behavioral: Fragmented Pain Neuroscience Education (FPNE)
Pain Neuroscience Education (PNE) will be administered in workshop sessions with interactive presentations, using different resources as metaphors and videos. It will be held in 2 sessions of 60 minutes each, covering 6 topics of Explain Pain and Explain Pain Supercharged books.
Other: Manual Therapy
Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.
Other: Orofacial and Neck Exercises (ONE)

Orofacial Exercises: Mandibular body-condylar cross-pressure chewing technique; Post-isometric relaxation stretches-laterotrusion and opening (10 times/session; 10 seconds).

Neck Motor Control Exercises: Bracing exercises (6 hierarchical levels - HL). Extreme range of motion exercises (stable spine). Cervical isometric exercises (5 HL) directly forward, obliquely, toward right and left, and directly backward (stable spine - elastic resistive bands). Functional training with elastic resistance and exercise balls on unstable surfaces (8 HJ). The progress in each exercise domain will happen when sustaining the contraction for 10 seconds, 10 times.
Experimental: Condensed Pain Neuroscience Education + Manual Therapy + Orofacial and Neck Exercises
All participants in this arm will initially receive two 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 60 minutes each. Two protocols of Orofacial Exercises and Manual Therapy and of Neck Motor Control will be adopted in the present 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 consist of orofacial therapy and exercises and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.
Other: Manual Therapy
Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.
Other: Orofacial and Neck Exercises (ONE)

Orofacial Exercises: Mandibular body-condylar cross-pressure chewing technique; Post-isometric relaxation stretches-laterotrusion and opening (10 times/session; 10 seconds).

Neck Motor Control Exercises: Bracing exercises (6 hierarchical levels - HL). Extreme range of motion exercises (stable spine). Cervical isometric exercises (5 HL) directly forward, obliquely, toward right and left, and directly backward (stable spine - elastic resistive bands). Functional training with elastic resistance and exercise balls on unstable surfaces (8 HJ). The progress in each exercise domain will happen when sustaining the contraction for 10 seconds, 10 times.

Behavioral: Condensed Fragmented Pain Neuroscience Education (CPNE)
Pain Neuroscience Education (PNE) will be administered in workshop sessions with interactive presentations, using different resources as metaphors and videos. It will be held in 8 sessions of 15 minutes each, covering 6 topics of Explain Pain and Explain Pain Supercharged books.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain intensity
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The Numerical Pain Rating Scale will be used to assess pain intensity in this trial. It consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Immediately after treatment, three-, six- and twelve- month follow-up
Change in Orofacial Pain related Disability
Time Frame: Immediately after treatment, three-, six- and twelve- 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. It 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 a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.
Immediately after treatment, three-, six- and twelve- month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain-Related Self-efficacy
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The Pain Self-Efficacy Questionnaire (PSEQ) will be used to measure pain self-efficacy beliefs (ability to function despite pain). Each item is rated by selecting a number on a 7-point scale, where 0 equals ''not at all confident'' and 6 equals ''completely confident''. A total score is calculated by summing the scores for each of the 10 items, resulting in a maximum possible score of 60. Higher scores reflect stronger self-efficacy beliefs. In the study analyzing the measurement properties of the Brazilian Portuguese version, the reliability of the PSEQ was considered adequate (the correlation divided in half was 0.76 and the internal consistency was 0.90).
Immediately after treatment, three-, six- and twelve- month follow-up
Change in Kinesiophobia
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The kinesiophobia outcome will be measured using the Tampa Scale For Kinesiophobia for Temporomandibular Disorders (TSK/TMD-Br). This is an 18-item self-report instrument that assesses fear of movement. The version translated into Brazilian Portuguese, TSK/TMD-Br, has 12 items. Each item is scored on a 4-point Likert scale, ranging from "strongly disagree" (score = 1) to "strongly agree" (score = 4). Responses are summed to produce a total score in which higher values reflect greater fear of movement (12-48 points) The TSK/TMD has good reliability (CCI = 0.66-0.83) and acceptable validity values (VISSCHER et al., 2010). Internal consistency analysis demonstrated adequate Cronbach's α values (>0.70) for all domains and reliability demonstrated excellent ICC values for all domains (ICC>0.75).
Immediately after treatment, three-, six- and twelve- month follow-up
Change in Global Perceived Effect of Improvement
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The Global Perceived of Effect of improvement has 11 points and ranges from -5 ("much worse") to 0 ("no change") to +5 ("completely recovered"). A higher score indicates greater recovery from the condition.
Immediately after treatment, three-, six- and twelve- month follow-up
Status of Empathy with the care provider
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The CARE Empathy Scale measures the degree of perception of empathy on the part of the patient, which can influence the effectiveness of the intervention. The instrument consists of 10 items, with additional explanations of colloquial language, aiming to facilitate understanding of the questions. The answers range from 1 "poor" to 5 "excellent". All item values are then added together, providing a final score between 10 and 50. The version translated into Brazilian Portuguese has a Cronbach's alpha coefficient of 0.867.
Immediately after treatment, three-, six- and twelve- month follow-up
Previous and acquired knowledge about pain neuroscience
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The Neurophysiology of Pain Questionnaire (NPQ) will be used to verify learning related to the pain neuroscience education program. The 19 items have the following response options: true, false, undecided. Each correct question receives a score of 1. Incorrect answers and/or answers marked as undecided are not scored. The NPQ is scored out of 19 with 1 point awarded for each correct response. A score of 0 is attributed to incorrect responses and those marked as undecided. The internal consistency analysis revealed a reliability value of alpha = 0.63.
Immediately after treatment, three-, six- and twelve- month follow-up
Beliefs about pain
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The Concept Of Pain Inventory for Adults (COPI-ADULT) will be administered to assess participants' beliefs about pain. This instrument consists of 13 items. The items are presented on a 5-point Likert scale: 0 strongly disagree; 1 disagree; 2 I'm not sure; 3 agree and 4 strongly agree. Higher COPI-Adult scores reflect greater alignment with contemporary pain science (total scores can range from 0 to 52). It presents acceptable internal consistency (α=0.78) and good test-retest reliability at 1 week (intraclass correlation coefficient of 0.84 (95% confidence interval: 0.71-0.91).
Immediately after treatment, three-, six- and twelve- month follow-up
Previous and current exercise adherence behaviour
Time Frame: Immediately after treatment, three-, six- and twelve- month follow-up
The Exercise Adherence Assessment Scale (EARS-Br) is made up of six items that assess the exercise behavior adherence and has 5 possible answer options (0 = completely agree to 4 = completely disagree), the total score ranges from 0 to 24 points, the higher the score, the greater the adherence. The structure of the single-factor EARS-Br instrument with 6 items showed acceptable fit indices (comparative fit index and goodness-of-fit index > 0.90 and root mean square error of approximation < 0.08). The EARS-Br scale showed acceptable internal consistency (α = 0.88) and excellent reliability (ICC = 0.91). A Minimally Important Change (MIC) of 5.5 in the EARS-Br total score was considered a significant change in adherence behavior (AUC = 0.82). Moderate accuracy (AUC = 0.89) was obtained for a total EARS cutoff score of 17/24 after home exercise prescription. Sensitivity and specificity are also acceptable (greater than 80%).
Immediately after treatment, three-, six- and twelve- month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Investigators

  • Study Chair: Thais Chaves, Ph.D, Federal University of São Carlos - UFSCar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 2, 2024

Primary Completion (Estimated)

December 10, 2027

Study Completion (Estimated)

December 10, 2027

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77273924.9.0000.5504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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