Temporomandibular DisordersNCT03990662

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

An observational study of Temporomandibular Disorders, run by Istituto Stomatologico Italiano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Temporomandibular Disorders
What is being tested?: Physiotherapy - Manual Therapy
How many people: 180 participants
Where: 1 siteItaly
Study dates: 14 Jun 2019to 1 Jan 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

(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.

Who cannot join

(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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Stomatologico Italiano
Miano, Milano, 20122

Other trials in Italy

About this study

Official title: 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.

Read the 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).

Conditions: Temporomandibular Disorders
Being tested: Physiotherapy - Manual Therapy
Keywords: Temporomandibular Joint Dysfunction Syndrome, Manual Therapy, Prediction, Pain
Medical subject headings: Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physiotherapy - Manual TherapyOther
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.

Study groups in NCT03990662
Study group	Role	What they receive
TMD		Patients (aged ≥18 years) with a diagnosis of Temporomandibular Disorders Receives: Other: Physiotherapy - Manual Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from baseline to two month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jun 20191 Jan 2025

First posted19 Jun 2019
Study start14 Jun 2019
Primary completion1 Jan 2025
Study completion1 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03990662
Sponsor's protocol ID: PredictorsOutcomeTMD2019GA
Status last verified: May 2025
First submitted: 17 Jun 2019
Last updated: 14 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41216702
Asquini G, Devecchi V, Viscuso D, Bucci R, Michelotti A, Liew BXW, Falla D. An exploratory data-driven approach to classify subgroups of patients with temporomandibular disorders based on pain mechanisms. J Pain. 2025 Jan;26:104721. doi: 10.1016/j.jpain.2024.104721. Epub 2024 Oct 25.
PubMed 39461455
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.
PubMed 37451727
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.
PubMed 35939919
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.
PubMed 33529226
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.
PubMed 31722951

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Temporomandibular Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictors of Good Outcomes Following Manual Therapy in Patients With Temporomandibular Disorders: Development and Validation Studies
ClinicalTrials.gov ID: NCT03990662
Acronym / sponsor ID: PredictorsOutcomeTMD2019GA
Conditions: Temporomandibular Disorders
Keywords: Temporomandibular Joint Dysfunction Syndrome, Manual Therapy, Prediction, Pain
Study type: Observational
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Istituto Stomatologico ItalianoUniversity, hospital or other
Collaborators: University of Birmingham
Study start: 14 Jun 2019 (actual)
Primary completion: 1 Jan 2025 (actual)
Study completion: 1 Jan 2025 (actual)
First posted: 19 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE OF THE OBSERVATION STUDY:

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.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
TMD	–	Other: Physiotherapy - Manual TherapyPatients (aged ≥18 years) with a diagnosis of Temporomandibular Disorders

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients will be recruited in a Dental Hospital [TMJ Unit].

Key inclusion criteria (5 listed)

(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.

Key exclusion criteria (3 listed)

(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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physiotherapy - Manual TherapyParticipants 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.	Other	TMD

Primary outcome

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 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 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 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
Derived from this study: PubMed 41216702Asquini 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.
Derived from this study: PubMed 39461455Asquini G, Devecchi V, Viscuso D, Bucci R, Michelotti A, Liew BXW, Falla D. An exploratory data-driven approach to classify subgroups of patients with temporomandibular disorders based on pain mechanisms. J Pain. 2025 Jan;26:104721. doi: 10.1016/j.jpain.2024.104721. Epub 2024 Oct 25.
Derived from this study: PubMed 37451727Asquini 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.
Derived from this study: PubMed 35939919Asquini 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.
Derived from this study: PubMed 33529226Asquini 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.
Derived from this study: PubMed 31722951Asquini 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.
Individual participant dataSharing planned: No

Related trials for Temporomandibular Disorders

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giacomo Asquini principal investigator

Istituto Stomatologico Italiano

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Disorders, run by Istituto Stomatologico Italiano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (Visual Analogue Scale [VAS]) from baseline to one month (time frame: Change from baseline to one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03990662, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.