Arthritis Clinical Trial
Official title:
Corticosteroids as Additive in Arthrocentesis of the Temporomandibular Joint: Double Blind, Randomised Controlled Trial of Effectiveness.
The aim is to compare the effectiveness of corticosteroid administration (dexamethasone) with a placebo (saline), following arthrocentesis of for the temporomandibular joint (TMJ). Twenty-eight participants with TMJ arthralgia, mainly related to osteoarthritis ae randomly assigned to two arms of a parallel double blind RCT. In both arms an arthrocentesis procedure is carried out, while a single dose intraarticular dexamethasone was delivered to participants in one arm. Saline was delivered in the other arm to serve as a control. Follow up visits were scheduled after 1, 3 and 24 weeks. During each visit TMJ pain (on a 100mm VAS) and joint stiffness (mouth opening in mm) are scored. Generalized estimating equations (GEE) are used for statistical analysis.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Pain localized in one of the TMJs (TMJ arthralgia). Exclusion Criteria: - No significant relief of pain within 10 minutes after anaesthesia (injecting 0,1 ml articaine 40 mg/ml) of the TMJ - Past history of open surgery in the affected joint - Known polyarthritis (mostly rheumatoid arthritis) - Age under 18 yrs - Ankylosis of the TMJ - Reported pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Centre Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in TMJ pain at 24 weeks | Change over 24 weeks from baseline for TMJ pain at rest and during mandibular movements. Measured by a 100 mm Visual Analogue Scale (VAS), limited by "no pain" and "worst pain imaginable". | 0 (T0), and at 1 (T1), 3 (T2) and 24 (T3) weeks. | No |
Primary | Change from Baseline in Maximal interincisal opening at 24 weeks | Change over 24 weeks from baseline maximal interincisal opening at rest and during mandibular movements . Measured in mm between the incisal edges of the center incisors. | T0, and at T1, T2 and T3. | No |
Secondary | Change from baseline of mandibular function impairment at 24 weeks. | Change over 24 weeks from baseline for the MFIQ. The MFIQ is a questionnaire assessing, on a five point scale, discomfort while performing mandibular functions and during eating of food with different consistencies (range of 0 - 68). | T0, T1, T2 and T3 | No |
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