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Report for D013705: Temporomandibular Joint Disorders NIH

(Synonyms: Tem, Temporom, Temporoman, Temporomandibular, Temporomandibular Joint Disorders)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2117 Physiotherapy - Manual Therapy Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D013706 Temporomandibular Joint Dysfunction Syndrome NIH 1.00

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Predictors of Pain Reduction Following Manual Therapy in Patients With Temporomandibular Disorders: a Prospective Observational Study

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 and questionnaires concerning their state of health (e.g. quality of sleep) with particular reference to Temporomandibular Disorder (e.g. location and duration of pain). The intensity of pain at the beginning of the study and the end of the observed therapy (one month) will then be monitored. 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.

NCT03990662 Temporomandibular Disorders Other: Physiotherapy - Manual Therapy
MeSH:Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Temporomandibular Joint Dysfunction Syndrome

Primary Outcomes

Description: 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

Measure: Pain Intensity: Visual Analogue Scale [VAS]

Time: one month, three months

Secondary Outcomes

Description: COVID Stress Scales (CSS): The CSS are a 36-items scales composed of five domains: danger and contamination fears, fears about economic consequences, xenophobia, compulsive checking and reassurance-seeking, and traumatic stress symptoms about COVID-19. All items are scored on a 5-point scale ranging from 0 to 4, with elevated values indicating high COVID-related impact. Current evidence revealed that CSS worked with acceptable values of reliability and validity.

Measure: COVID-19 Related Distress

Time: three months

Other Outcomes

Description: Health-related quality of life was evaluated through a visual analogue scale (range 0-100) representing 'worst' to 'best' possible health.

Measure: General health variables

Time: three months

Description: An 11-point Numerical Rating Scale [NRS] was adopted to estimate sleep quality, where 0 is 'best possible sleep' and 10 is 'worst possible sleep'. This scale was used to assess the average sleep quality related to the preceding 6-months at baseline and related to the preceding 3-months at the follow-up.

Measure: Sleep Quality

Time: three months

Description: The Hospital Anxiety and Depression Scales (HADS): Depression and anxiety were measured with the Italian version of the HADS at baseline and at the follow-up assessment. HADS is made up of two 7 items subscales [anxiety: HADS-A; depression: HADS-D]. The score ranges from 0 to 21 with higher values indicating greater levels of anxiety and depression. HADS has excellent concurrent validity in comparison to other depression/anxiety scales, and adequate to excellent internal consistency (HADS-A [0.68-0.93]; HADS-D [0.67-0.90]).

Measure: Depression and anxiety

Time: three months

Description: Coping Strategies Questionnaire 27 (CSQ-27): The Italian version of the CSQ-27 was applied to assess strategies for coping with pain at baseline and at the follow-up. 40 This questionnaire includes six domains: Distraction, Catastrophizing, Ignoring pain sensations, Distancing from pain, Coping self-statements, and Praying. Participants were asked to score the specific strategies utilising a seven-point Likert scale for each domain. Possible scores range from 0 "never do that" to 6 "aways do that".

Measure: Coping Strategies

Time: three months

Description: Central Sensitization Inventory (CSI): Participants completed the part A of the Italian version of the CSI at baseline and follow-up. This questionnaire is composed of 25 items with five possible answers ranging from 'never' (0) to 'always' (4) concerning current health symptoms. Significant test-retest reliability and internal consistency were found for CSI in people with and without pain.

Measure: Central Sensitization

Time: three months

Description: The Italian version of the Research Diagnostic Criteria for TMD (RDC/TMD) questionnaire Axis II Graded Chronic Pain Scale (GCPS) version -2.0 [www.rdc-tmdinternational.org] was administered by following the DC/TMD protocol recommendations. In this study, the GCPS was used to appraise facial pain severity related to the preceding 6-months at baseline and related to the last 3 months at follow-up. This scale unifies pain intensity and pain-related disability into one of the five ordinal categories of chronic facial pain severity. 67 Pain intensity is measured through the characteristic pain intensity (CPI) score (range: 0-100). A disability score (range: 0-6) is obtained from a combination of the number of disability days and the disability level.

Measure: Characteristic pain intensity and disability

Time: three months

Description: The Italian version of the RDC/TMD questionnaire Axis II Oral Behaviours Checklist (OBC) [www.rdc-tmdinternational.org] was administered at baseline and at the follow-up by following the DC/TMD protocol recommendations. The OBC is a 21 item questionnaire with five possible answers ranging from 'none of the time' (0) to 'all of the time' (4), referring to activities related to the preceding month involving the jaw such as clenching or grinding the teeth.

Measure: Oral Behaviour

Time: three months


HPO Nodes