Arthralgia, internal derangement and degenerative joint disease (i.e. osteoarthritis) of the temporomandibular joint
Conditions
Interventions
Investigational intervention is diagnostic arthroscopic (lysis and lavage)
Control intervention is arthrocentesis
Sponsors
UMCG
Eligibility
Inclusion criteria
Inclusion criteria: - Patients aged > 18 years - Arthralgia of the TMJ, proven with a diagnostic intra-articular injection with Ultracain DS Forte (articaine 4% + 1:100.000 adrenalin; Aventis Pharma, Hoevelaken, The Netherlands). - TMJ pain still present after two weeks of NSAIDs (i.e. diclofenac 3 times daily 50mg) - Symptoms presenting unilaterally or bilaterally with a maximal Visual Analog Scale (VAS)-score < 30 mm during movement or function of the contralateral joint, after anesthetizing the to be treated joint (thus avoiding the contralateral joint to be the cause of a limited mouth opening).
Exclusion criteria
Exclusion criteria: - Systemic rheumatic disease (such as rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, Sjögren syndromes, psoriatic arthritis) - Connective tissue disease (such as Marfan syndrome, Ehlers-Danlos syndrome, Osteogenesis Imperfecta) - Bony ankylosis of the TMJ - Congenital or acquired dentofacial deformity - History of jaw trauma that resulted in jaw or joint pain, bony changes or mandibular growth restriction - Prior arthrocentesis, (diagnostic) arthroscopy or open-TMJ surgery - Psychiatric disorder (as diagnosed by a physician) - Unwillingness to receive one of the study treatments - Pregnancy at time of treatment - Concurrent use of steroids, sedatives, muscle relaxants or anti-inflammatory drugs other than the previously prescribed NSAIDs - Incompetence to speak the Dutch or English language - Medical comorbidities such as coagulation disorders, diabetes mellitus type I or II, kidney failure, heart failure, cardiac ischemia, hypertension and history of HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain perceived by the patient during mandibular movement or function using the Visual Analogue Scale (VAS; ranging 0-100mm). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain perceived by the patient at rest using the VAS (ranging 0-100mm) - Maximum Interincisal Opening (MIO; in mm) without perceiving (increased) pain measured by the clinician with a caliper - Maximum Interincisal Opening (MIO; in mm) measured by the clinician with a caliper - Mandibular range of motion (MROM) measured by the clinician with a dental pocket probe (proal and lateral movements; in mm) - Joint blocks and noises (i.e. clicks, crepitation, pops) perceived by the patient in the last 3 months (absent/ present) - Impairment of mandibular function as perceived by the patient using the validated mandibular function impairment questionnaire (MFIQ; 17 items scored on a Likert scale, with the total score ranging 0-68) - Cost-effectiveness (using the composite of the primary study outcome variable ‘VAS-score during movement or function’ and ‘costs’, and a second cost-effectiveness analysis using ‘MFIQ-score’ and ‘costs’) - Safety (measured as kind and amount of adverse and serious adverse events) | — |
Contacts
Public ContactYang Hang Tang
University Medical Center Groningen (UMCG)
Outcome results
None listed