Diagnostic arthroscopy versus arthrocentesis as initial treatment for arthralgia of the temporomandibular joint
- Conditions
- Arthralgia, internal derangement and degenerative joint disease (i.e. osteoarthritis) of the temporomandibular joint
- Registration Number
- NL-OMON20171
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
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).
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain perceived by the patient during mandibular movement or function using the Visual Analogue Scale (VAS; ranging 0-100mm).
- Secondary Outcome Measures
Name Time Method