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ID
Source
Brief title
Health condition
Arthralgia, internal derangement and degenerative joint disease (i.e. osteoarthritis) of the temporomandibular joint
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain perceived by the patient during mandibular movement or function using the Visual Analogue Scale (VAS; ranging 0-100mm).
Secondary outcome
- 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)
Background summary
Internal derangement (ID) and degenerative joint disease (DJD) of the temporomandibular joint (TMJ) are the most common causes of arthralgia of the TMJ. When these disorders are symptomatic, elevated pro-inflammatory cytokines and degradation products are often present in the synovial fluid of the joint. The lavage of the joint with arthrocentesis as initial treatment may wash these harmful products away and is shown to be an (cost-)efficient way in reducing clinical symptoms of DJD and ID.
The more advanced procedure diagnostic arthroscopy/ single portal arthroscopic lysis and lavage under localized anesthesia also enables the lavage of the joint, but additionally allows lysis and localized injections with corticosteroids. Currently, diagnostic arthroscopy is only performed when arthrocentesis is proven to be insufficient in reducing clinical symptoms. Indicating diagnostic arthroscopy as first-line (therefore replacing arthrocentesis) treatment for TMJ-arthralgia may prevent further degeneration of the joint and reduce clinical symptoms more efficiently than arthrocentesis.
The aim of the study is therefore to evaluate the (cost-)efficiency of diagnostic arthroscopy in reducing clinical symptoms compared to arthrocentesis under local
anesthesia as initial treatment in patients with arthralgia (with or without reduced mobility) of the TMJ.
The study design is a single-center single-blind randomized controlled trial, conducted in the University Medical Center Groningen (UMCG). An estimated 140 subjects will be randomized in two arms (50:50 ratio).
Study objective
Diagnostic arthroscopic (lysis and lavage) reduces clinical symptoms more rapidly and efficaciously than arthrocentesis.
Study design
3 months, 6 months and 12 months.
Intervention
Investigational intervention is diagnostic arthroscopic (lysis and lavage);
Control intervention is arthrocentesis
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9701 |
| Other | METC UMCG : METc 2021/275 |