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

NCT03990662 | Completed

• 1 other identifier: PredictorsOutcomeTMD2019GA
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Disorders

Keywords

Temporomandibular Joint Dysfunction Syndrome; Manual Therapy; Prediction; Pain

Outcome Measures

Primary Outcomes (4)

• Change in Pain Intensity (Visual Analogue Scale [VAS]) 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

  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

  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

  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 Outcomes (6)

• Pain during maximal mouth opening

  Baseline, one month, two months

• Central sensitisation: Central Sensitisation Inventory (CSI)

  Baseline

• Treatment expectations

  Baseline

Study Arms (1)

TMD

Patients (aged ≥18 years) with a diagnosis of Temporomandibular Disorders

Other: Physiotherapy - Manual Therapy

Interventions

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.

TMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Istituto Stomatologico Italiano: lead
• University of Birmingham: collaborator

Study Sites (1)

Istituto Stomatologico Italiano

Miano, Milano, 20122, Italy

Location

Related Publications (5)

• Asquini G, Devecchi V, Borromeo G, Tessera P, Russillo A, Michelotti A, Bucci R, Falla D. External Validation of a Clinical Prediction Tool for the Use of Manual Therapy in Patients With Temporomandibular Disorders. J Oral Rehabil. 2026 Feb;53(2):515-528. doi: 10.1111/joor.70092. Epub 2025 Nov 11.

  PMID: 41216702 DERIVED

• Asquini G, Devecchi V, Edoardo Bianchi A, Borromeo G, Tessera P, Falla D. External validation of a clinical prediction tool for the use of manual therapy for patients with temporomandibular disorders: a protocol for a prospective observational study. BMJ Open. 2023 Jul 14;13(7):e069327. doi: 10.1136/bmjopen-2022-069327.

  PMID: 37451727 DERIVED

• Asquini G, Devecchi V, Borromeo G, Viscuso D, Morato F, Locatelli M, Falla D. Predictors of pain reduction following a program of manual therapies for patients with temporomandibular disorders: A prospective observational study. Musculoskelet Sci Pract. 2022 Dec;62:102634. doi: 10.1016/j.msksp.2022.102634. Epub 2022 Jul 31.

  PMID: 35939919 DERIVED

• Asquini G, Bianchi AE, Borromeo G, Locatelli M, Falla D. The impact of Covid-19-related distress on general health, oral behaviour, psychosocial features, disability and pain intensity in a cohort of Italian patients with temporomandibular disorders. PLoS One. 2021 Feb 2;16(2):e0245999. doi: 10.1371/journal.pone.0245999. eCollection 2021.

  PMID: 33529226 DERIVED

• Asquini G, Bianchi AE, Heneghan NR, Rushton AB, Borromeo G, Locatelli M, Falla D. Predictors of pain reduction following manual therapy in patients with temporomandibular disorders: a protocol for a prospective observational study. BMJ Open. 2019 Nov 12;9(11):e032113. doi: 10.1136/bmjopen-2019-032113.

  PMID: 31722951 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Giacomo Asquini

  Istituto Stomatologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist at the Italian Stomatologic Institute - Craniomandibular Physiotherapy Service

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: June 14, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)