What Are the Clinical Factors Associated With a Significant Pain Reduction Following Physiotherapy in Patients With Temporomandibular Disorders?
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Pain Intensity: Visual Analogue Scale [VAS] [one month, three months]
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
Secondary Outcome Measures
- COVID-19 Related Distress [three months]
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.
Other Outcome Measures
- General health variables [three months]
Health-related quality of life was evaluated through a visual analogue scale (range 0-100) representing 'worst' to 'best' possible health.
- Sleep Quality [three months]
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.
- Depression and anxiety [three months]
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]).
- Coping Strategies [three months]
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".
- Central Sensitization [three months]
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.
- Characteristic pain intensity and disability [three months]
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.
- Oral Behaviour [three months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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(1) adults aged ≥18 years;
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(2) TMD diagnosis according to the Axis I of the Diagnostic Criteria for TMDs (DC/TMD) (Shiffman et al., 2014);
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(3) no therapeutic interventions reported (for their TMD) in the past six months (Wahlund et al., 2015);
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(4) capacity to use and understand written and verbal Italian language;
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(5) mental capacity to provide informed consent.
Exclusion Criteria:
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(1) TMD pain related to rheumatoid/inflammatory arthritis;
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(2) any physical or mental condition that could potentially influence the study;
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(3) they commence another treatment for their TMD (pharmacology, oral appliance, others) throughout the duration of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Stomatologico Italiano | Miano | Milano | Italy | 20122 |
Sponsors and Collaborators
- Istituto Stomatologico Italiano
- University of Birmingham
Investigators
- Principal Investigator: Giacomo Asquini, Istituto Stomatologico Italiano
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PredictorsOutcomeTMD2019GA