Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders

July 9, 2024 updated by: María Teresa Ortiz Moreno, University of Alcala

Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders: a Single-blind Randomized Controlled Trial

The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). The hypothesis of this study is that the PNE+TE group will obtain superior therapeutic results than an isolated TE program.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: To evaluate the differences in pain intensity by performing isolated therapeutic exercise (TE) versus performing the same exercise combined with pain neurophysiology education (PNE) in patients with temporomandibular disorders (TMD).

Design: Single-blind randomized controlled trial. Setting: Faculty of Physical Therapy of Alcalá de Henares. Participants: Subjects with TMD lasting more than 6 months (N= 36). Interventions: Participants will be randomly assigned to receive a TE program consisting of stretching, coordination and strengthening exercises (n= 18) or the same TE program in addition to a PNE program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. The intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again.

Main outcome measures: The primary outcome will be pain intensity through the visual analogue scale (VAS) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. Secondary outcome measures include pain-free mouth opening, Craniofacial Pain and Disability Inventory (CF-PDI), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-11), pressure pain thresholds (PPT) and Patient Global Impression of Change (PGIC). They will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. Student's t test will be used to determine differences between group interventions.

Study Type

Interventional

Enrollment (Estimated)

36

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

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28804
        • Campus Científico Tecnológico UAH. AV. de León, 3A.
        • 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 18 years of age
  • Limitation of mouth opening and/or jaw pain lasting more than 6 months
  • Being able to understand the objective and carry out the study procedures
  • Sign the informed consent.

Exclusion Criteria:

  • Suffer from any underlying disease
  • Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
  • Be receiving any other treatment for TMD or consuming some type of substance that alters muscle tone.
  • Patients with myopathies, diseases of the Peripheral Nervous System, mental disorders diagnosed by a doctor
  • Inability to collaborate
  • Any other situation in which the evaluation could be altered.

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
Experimental: TE+PNE group
patients with TMD who are going to combine therapeutic exercise with education in pain neurophysiology
Behavioral: Therapeutic Exercise
A therapeutic exercise program will be carried out
Behavioral: Pain Neurophysiology Education
A PNE program will be carried out
Other: TE group
patients with TMD who are going to perform isolated therapeutic exercise
Behavioral: Therapeutic Exercise
A therapeutic exercise program will be carried out

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
The intensity of pain will be evaluated using the Visual Analogue Scale that is represented by a 10cm line where the left end indicates "no pain" and the right end indicates "maximum pain".
The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mouth opening without pain
Time Frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The distance between the upper and lower mandibular central incisors will be measured using a TheraBite range of motion scale.
at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Orofacial disability and pain
Time Frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The CF-PDI is a self-administered questionnaire that measures pain and disability outcomes related to craniofacial pain. It consists of 21 items, with a score ranging from 0 to 63 points. A higher score reflects higher levels of disability.
at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Catastrophism
Time Frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The PCS consists of a self-administered questionnaire with 13 items for the evaluation of catastrophic thoughts. It is divided into three domains: helplessness, magnification and rumination. Higher values denote greater pain catastrophizing
at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Kinesiophobia
Time Frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The Spanish version of the TSK-11 will be used to evaluate the fear of re-injury due to movement. This questionnaire has a structure of 11 items and 2 factors that includes avoidance and harm of activities. Higher scores reflect greater fear of movement
at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Pressure pain thresholds
Time Frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
The masseter and anterior temporal PPTs will be assessed bilaterally using an analog algometer. Measurements will be reported in kg/cm2. The points will always be evaluated in the same order and will be repeated three times, with an interval of 1 minute. For each point the average of the three measurements will be considered.
at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Self-Perception of Improvement
Time Frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
PGIC will be used to assess perceived improvement after treatment (range, 0-7). Higher scores will indicate greater improvement
at baseline, immediately after treatment, 4 and 12 weeks after treatment.

Collaborators and Investigators

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

Sponsor

University of Alcala

Investigators

  • Principal Investigator: María Teresa Ortiz-Moreno, MSc, University of Alcala
  • Study Director: Gema Bodes-Pardo, PhD, University of Alcala

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)

September 1, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Temporomandibular disorders

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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