Temporomandibular Joint Dysfunction Syndrome
Conditions
Interventions
Randomization will be performed before the procedures using an internet-based computer program (http://www.randomization.com/) in blocks of 4 patients (block size unknown to the investigators) by a te
Sponsors
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Eligibility
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Volunteers of both genders; aged between 20 and 50 years; with myofascial Temporomandiibular Disorders; in pain for more than three months; refractory to conventional therapies
Exclusion criteria
Exclusion criteria: Volunteers with facial and Temporomanbular Joint trauma; using full dentures or removable partial dentures; ongoing orthodontic treatment; blood dyscrasia patients; with presence of arthritis; arthrosis; diabetes; neurological pathologies; fibromyalgia; who received tetanus vaccine or botulinum toxin injections in the three months prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Pain reduction in a period of six months, verified through the methods of Visual Analog Scale (VAS) and Pain to Pressure Threshold (PPT), from the evidence of a decrease of at least 2 points in VAS and 5% in PPT in pre and post-intervention measurements.;Outcome found 1:Baseline data showed no between-group differences in pain intensity (VAS). The median (min-max) pain intensity in the botulinum toxin group at baseline was 76 (53-95) and 70 (50-90) in the saline solution group. After treatment, the pain intensity in the botulinum toxin group had a significant decrease to 40 (16-66) and 28 (0-46) at the 1- and 6-months - follow-up. Results for the saline solution-group after treatment were 64 (30-83) and 56 (33-80) for the 1- and 6-months follow-up. The differences between groups were significant at both follow-ups. For Pain Pressure Threshold (PPT) results, in the botulinum toxin group, a significant increase was found in PPT values in all post-treatment assessments compared to baseline (p0.05). No time effect or between-drug difference was found in temporal summation assessment (p>0.05). In the thenar muscle, there was no difference in any mechanical pain parameters in the intra- and inter-group comparisons (p>0.05). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3: Decrease in psychosocial impairment in six-month period, verified through anxiety, depression and stress questionnaires; with an evidence of a decrease of at least 5% in pre and post-intervention measurements.;Outcome found 3: Intra-groups comparisons showed that only the botulinum toxin treatment significantly improved the scores of Hospital Anxiety and Depression Scale (p=0.05), Central Sensitization Inventory (p=0.002), Perceived Stress Scale (p=0.006), Pittsburgh Sleep Quality Index (p=0.002), Pain Catastrophizing Scale (p=0.02), Pain Vigilance and Awareness Questionnaire (p=0.02), Short Form Health Survey 36 (p=0.05) while saline solution showed no significant changes. Inter-group comparison showed greater values for Central Sensitization Inventory (p=0.01), Pittsburgh Sleep Quality Index (p=0.004), and Short Form Health Survey 36 (3, 4, 5) (p=0.05) after treatment for the botulinum toxin group than for the saline solution group. | — |
Countries
Brazil
Contacts
Public ContactGiancarlo De la Torre Canales
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Outcome results
None listed