Intra-articular corticosteroid injection vs arthrocentesis in the management of clinical arthritis of the temporomandibular joint: a randomized controlled trial.

Phase 1

Conditions: Arthritis of the temporomandibular joint
Therapeutic area: Diseases [C] - Stomatognathic Diseases [C07]

Registration Number: CTIS2023-509114-11-00

Lead Sponsor: Vaestra Goetalandsregionen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

age = 18 years, TMJ clinical arthritis in one or both joints, Understand swedish orally and in writing, Given written consent to participate in the study, Has been given information about the condition and treatment in postural exercises

Exclusion Criteria

Allergy to methyl-prednisolone or any other content in the drug, Fungusinfection that affect the body, Local virus- or/and bacteriainfection, TMJ joint surgery or trauma during the last two years, Cortisone injection in the TMJ the last 3 months, Patients whose condition can be related to other diseases for instance auto-immune disease, neurologic disease, myalgia or tooth ache

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare pain relief of TMJ intra-articular cortisone injection versus arthrocentesis for the management of clinical TMJ arthritis;Secondary Objective: To evaluate maximum mouth opening for TMJ arthrocentesis versus cortisone injection at 1, 3 and 6 months after treatment, Do psychosocial factors have and impact on treatment outcome?, Does the presence of degenerative bone changes in the temporomandibular joint affect treatment outcome in pain relief?;Primary end point(s): Pain relief will be measured with 100 mm VAS-scale at baseline, 1, 3 and 6 months after treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):The maximal mouth opening will be measured in mm at baseline, 1, 3 and 6 months after treatment with cortisoneinjection or arthrocentesis;Secondary end point(s):Psychosocial factors measurements will be collected at base examination in the clinic and the patients will have to fill out a questionnaire containing The Patient Health Questionnaire (PHQ-9 and PHQ-15), GAD-7, PCS. In every visit JFLS and GCPS will be measured through another questionnaire.;Secondary end point(s):Presence of degenerative bone changes will be examined by oral radiologist and graded as 0 (no bony changes) or 1 (bone changes in the TMJ).