Skip to main content
OpenTrials
Completed

NCT Number: NCT03990662

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Temporomandibular Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Stomatologico Italiano

Miano, Milano, 20122, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy - Manual Therapy

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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]

  3. 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.

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Istituto Stomatologico Italiano

Other

Collaborators

  • University of Birmingham

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2019
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.