What Are the Clinical Factors Associated With a Significant Pain Reduction Following Physiotherapy in Patients With Temporomandibular Disorders?

March 21, 2024 updated by: Giacomo Asquini, Istituto Stomatologico Italiano

Predictors of Good Outcomes Following Manual Therapy in Patients With Temporomandibular Disorders: Development and Validation Studies

RATIONALE OF THE OBSERVATION STUDY:

This study aims to observe which patients with temporomandibular disorder improve more following a physiotherapy program of four sessions. Knowing the characteristics of patients who have the most significant improvements could help clinician advise or advise against physiotherapy for the treatment of temporomandibular disorders.

STUDY PROCEDURES The study will be conducted at the Istituto Stomatologico Italiano. Patients diagnosed with Temporomandibular Disorder will be recruited in the gnathological and neuromuscular gnathological departments. The physiotherapists of the Craniomandibular Physiotherapy Service will perform physiotherapy therapy, which consists of four physiotherapy sessions [lasting 30 minutes, about once a week] over a month. Before starting the treatment, participants will be asked to answer some questions concerning their state of health (e.g. pain intensity) with particular reference to Temporomandibular Disorder (e.g. location and duration of pain). The intensity of pain and the level of function will then be monitored at baseline, after 4 weeks and after 8 weeks from baseline.

EXPECTED BENEFITS FROM THE STUDY AND EXPECTED BENEFITS FOR THE PATIENT The benefits are the discovery of new knowledge in the field of therapeutic choice for patients with temporomandibular disorder.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Additional information:

In this study protocol, the variables reported in the section "Other Pre-specified Outcomes" are the predictors that will be included in the prediction model.

The total "Enrollment" is 180 participants (100 for the development phase and 80 for the validation phase).

Study Type

Observational

Enrollment (Estimated)

180

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 Locations

  • Italy
    • Milano
      • Miano, Milano, Italy, 20122

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited in a Dental Hospital [TMJ Unit].

Description

Inclusion Criteria:

  • (1) adults aged ≥18 years;
  • (2) TMD diagnosis according to the Axis I of the Diagnostic Criteria for TMDs (DC/TMD) (Shiffman et al., 2014);
  • (3) no therapeutic interventions reported (for their TMD) in the past six months (Wahlund et al., 2015);
  • (4) capacity to use and understand written and verbal Italian language;
  • (5) mental capacity to provide informed consent.

Exclusion Criteria:

  • (1) TMD pain related to rheumatoid/inflammatory arthritis;
  • (2) any physical or mental condition that could potentially influence the study;
  • (3) they commence another treatment for their TMD (pharmacology, oral appliance, others) throughout the duration of the 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TMD
Patients (aged ≥18 years) with a diagnosis of Temporomandibular Disorders
Other: Physiotherapy - Manual Therapy
Participants will receive four sessions of manual therapy applied to craniomandibular structures over four weeks. The application of manual therapy aims to decrease pain by treating masticatory muscle trigger points, muscle tightness, and restricted temporomandibular joint movements. Several techniques will be considered, including ventral and caudal anterior glide temporomandibular joint mobilisation, soft tissue interventions for the management of trigger points in masticatory muscles and myofascial induction therapy applied to craniomandibular structures. The structures targeted in the treatment sessions will be the temporomandibular joint, temporal muscles, masseter muscles, medial and lateral pterygoid muscles and suprahyoid muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity (Visual Analogue Scale [VAS]) from baseline to one month
Time Frame: Change from baseline to one month
Pain intensity will be calculated by averaging the ratings of current pain, average pain in the past week, and worst pain in the past week using the Visual Analogue Scale (VAS), consisting of a horizontal line measuring 10 cm (without marks), with "no pain" written at the left extremity, and "worst pain imaginable" at the right extremity. Patients will be educated to trace a perpendicular line on the horizontal line to intend the pain intensity. The distance from the 0 points will be after measured in millimetres. The VAS is a reliable and valid scale to assess pain intensity as an outcome measure in intervention studies. Based on the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations about TMD , a reduction of at least 30% of the VAS score for pain intensity is considered clinically significant. Consequently, a reduction in the total VAS score [≥ 30%] will be defined as a good outcome
Change from baseline to one month
Change in Pain Intensity (Visual Analogue Scale [VAS]) from baseline to two month
Time Frame: Change from baseline to two month
Pain intensity will be calculated by averaging the ratings of current pain, average pain in the past week, and worst pain in the past week using the Visual Analogue Scale (VAS), consisting of a horizontal line measuring 10 cm (without marks), with "no pain" written at the left extremity, and "worst pain imaginable" at the right extremity. Patients will be educated to trace a perpendicular line on the horizontal line to intend the pain intensity. The distance from the 0 points will be after measured in millimetres. The VAS is a reliable and valid scale to assess pain intensity as an outcome measure in intervention studies. Based on the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations about TMD , a reduction of at least 30% of the VAS score for pain intensity is considered clinically significant. Consequently, a reduction in the total VAS score [≥ 30%] will be defined as a good outcome
Change from baseline to two month
Change in Function (patient specific functional scale [PSFS]) from baseline to one month
Time Frame: Change from baseline to one month
To capture a potential change in function, patients will also complete the patient specific functional scale (PSFS). The PSFS is a self reported outcome measure assessing functional change in patients with musculoskeletal disorders. It is responsive to clinically significant change over time, even in chronic pain patients. Patients are invited to rate, on an 11-point scale, their level of difficulty performing at least three different daily activities. Following the treatment, patients are required to score again the activities previously rated. It is known the PSFS is a valid, reliable, and responsive outcome measure with a high test-retest reliability in patients with lower back pain and knee problems.
Change from baseline to one month
Change in Function (patient specific functional scale [PSFS]) from baseline to two month
Time Frame: Change from baseline to two month
To capture a potential change in function, patients will also complete the patient specific functional scale (PSFS). The PSFS is a self reported outcome measure assessing functional change in patients with musculoskeletal disorders. It is responsive to clinically significant change over time, even in chronic pain patients. Patients are invited to rate, on an 11-point scale, their level of difficulty performing at least three different daily activities. Following the treatment, patients are required to score again the activities previously rated. It is known the PSFS is a valid, reliable, and responsive outcome measure with a high test-retest reliability in patients with lower back pain and knee problems.
Change from baseline to two month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during maximal mouth opening
Time Frame: Baseline, one month, two months
Pain intensity during maximal mouth opening will be measured via a Numeric Rating Scale (NRS) . Participants will be asked: "Rate your pain by indicating the number that best describes pain during maximal mouth opening, with 0 meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine' " . NRS is a reliable and valid tool to detect pain modification in clinical trials.
Baseline, one month, two months
Central sensitisation: Central Sensitisation Inventory (CSI)
Time Frame: Baseline
Participants will be asked to complete the Italian version of the CSI. CSI examines existing health symptoms through a 0-100 score for 25 items, each with five alternatives from 'never' (score 0) to 'always' (score 4). The CSI has adequate test-retest reliability and internal consistency in people with and without pain. The Italian version of the CSI has an acceptable Cronbach's alpha [0.87]
Baseline
Treatment expectations
Time Frame: Baseline
Participants will report if they "Completely disagree", "Somewhat disagree", "Neutral", "Somewhat agree", "Completely agree" with the following statement: "I believe that manual techniques applied to my jaw will significantly help to improve my pain". Only answers "somewhat agree" or "completely agree" are considered positive treatment expectations.
Baseline
Duration of TMD pain
Time Frame: Baseline
The duration of TMD pain will be collected in days and obtained from open hospital records and patient interviews
Baseline
Maximal mouth opening (MMO)
Time Frame: Basiline, one month, two months
MMO measurements will be in millimetres and calculated with a ruler in a neutral craniocervical position (e.g., sitting or supine) as suggested by the DC/TMD. The measurement procedure follows the DC/TMD protocol. MMO in a neutral craniocervical position is a reliable clinical measures and has good inter and intra-rater reliability
Basiline, one month, two months
Number of pain locations
Time Frame: Baseline
Participants will complete a pain drawing representing spatial pain distribution through a body frontal and dorsal view chart. The pain reported in distinct body regions (e.g., head, jaw area, back area, pelvic area, neck area) will be collected as the number of painful sites
Baseline

Collaborators and Investigators

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

Sponsor

Istituto Stomatologico Italiano

Collaborators

University of Birmingham

Investigators

  • Principal Investigator: Giacomo Asquini, Istituto Stomatologico Italiano

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 (Actual)

June 14, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PredictorsOutcomeTMD2019GA

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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