Pain relief following an intra-articular single dose metylprednisolon vs. placebo on temporomandibular joint artralgia patientens. A randomized controlled blinded multicenter study.

INTERVENTION: Trade Name: Depo‐Medrol 40 mg/ml injektionsvätska, suspension Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraarticular use CONDITION: Artralgia of the jaw joint Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: The primary objective is to evaluate the relief of pain at maximal mouth opening following a single dose intra‐articular metylprednisolon (Depo‐Medrol®) vs. placebo in patients with artralgia of the temporomandibular joint Primary end point(s): The differnce in VAS‐rated pain intensity at maximal mouth opening from baseline to end of study Secondary Objective: The secondary objectivs are to evaluate the relief of jaw pain at rest, mouth opening, jaw function, the consequences of pain and the emotional influence following the treatment. Also the variability of pain 3 days before and 5 days after the treatment as well as during 3 days before end of a one month evaluation period is tracked. Timepoint(s) of evaluation of this end point: After a month SECONDARY OUTCOME: Secondary end point(s): The differnce in VAS‐rated pain intensity at jaw rest from baseline to end of study ; Maximal opening without pain ; Maximal opening with pain ; Maximal assisted mouth opening ; Instruments ; JFLS ; GCPS ; PHQ‐9 ; PGIC Timepoint(s) of evaluation of this end point: After a month INCLUSION CRITERIA: age 18 or above the diagnosis artralgia in one jaw joint understands Swedish verbally and in written signed informed concent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14