jaw inflammation Osteoartritis
Conditions
Interventions
Control intervention is single-needle arthrocentesis of the temporomandibular
joint space. Study intervention is single-needle puncture arhtrocentesis of the
upper TMJ space with the injection of SV
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age between 18-60 years;Pain in the TMJ region;Pain still present after two weeks of ibuprofen 600 mg three times daily (exclusion of acute inflammatory pain) ;Pain disappears after intra-articular injection (Ultracain forte, Aventis Pharma, Hoevelaken, The Netherlands) ;Pain still present (VAS during movement more than 20mm) after 3 weeks after an initial arthrocentesis.
Exclusion criteria
Exclusion criteria: Systemic rheumatic disease ;Bony ankylosis of the TMJ ;Incompetence to speak the Dutch or English language ;Pregnancy ;Concurrent use of anti-inflammatory medication, steroids, muscle relaxants or antidepressants ;Unwillingness to receive one of the study treatments ;Prior open TMJ surgery ;Prior to liposuction;Coagulation disorders;BMI >18 ;BMI >25;Abnormalities in bloodanalysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is VAS pain scale (during movement and at rest) at baseline, and at 3, 12 and 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome variables are maximal mouth opening at baseline, and at 3, 12 and 26 weeks. Other outcome variables are based on patient questionnaires MFIQ and OHIP, at baseline, and after 3, 12, 26 weeks; complications during follow up; analysis of synovial cytokines at baseline and at 26 weeks; analysis of nucleated cells and characterization of the SVF in the intervention group. | — |
Countries
Netherlands
Outcome results
None listed