Study Comparing Corticosteroid Injection and Arthrocentesis for Temporomandibular Joint Arthritis in Patients Using Methylprednisolone Acetate and Lidocaine Hydrochloride

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What is this study about?

This clinical trial is focused on studying the treatment of arthritis of the temporomandibular joint (TMJ), a condition that affects the joint connecting the jaw to the skull, causing pain and difficulty in moving the jaw. The study will compare two treatments: an injection of corticosteroids directly into the joint, and a procedure called arthrocentesis, which involves washing out the joint to relieve pain and improve movement.

The medications used in this study include Depo-Medrol cum Lidocain, which contains methylprednisolone acetate and lidocaine hydrochloride, and Panodil, which contains paracetamol. Additionally, a solution of sodium chloride may be used. The purpose of the study is to determine which treatment provides better pain relief for patients with TMJ arthritis.

Participants in the study will receive either the corticosteroid injection or the arthrocentesis procedure. The study will monitor pain relief and jaw movement over several months. Participants will be asked to complete questionnaires about their health and any changes in their condition. The study aims to provide valuable information on the effectiveness of these treatments for managing TMJ arthritis.

1 initial assessment

An initial assessment is conducted to confirm eligibility for the trial. This includes verifying age (18 years or older), diagnosis of arthritis of the temporomandibular joint (TMJ) in one or both joints, and the ability to understand Swedish both orally and in writing.

Written consent is required to participate, and information about the condition and treatment, including postural exercises, is provided.

2 baseline measurements

Baseline measurements are taken, including pain levels using a 100 mm visual analog scale (VAS) and maximal mouth opening in millimeters.

Psychosocial factors are assessed through questionnaires, including the Patient Health Questionnaire (PHQ-9 and PHQ-15), Generalized Anxiety Disorder 7-item scale (GAD-7), and Pain Catastrophizing Scale (PCS).

An oral radiologist examines for degenerative bone changes in the TMJ, graded as 0 (no changes) or 1 (changes present).

3 treatment administration

Participants receive either an intra-articular corticosteroid injection or undergo arthrocentesis for TMJ arthritis management.

The corticosteroid injection involves a suspension containing methylprednisolone acetate and lidocaine hydrochloride, administered directly into the joint.

4 follow-up assessments

Follow-up assessments occur at 1, 3, and 6 months post-treatment.

Pain relief is measured using the VAS scale, and maximal mouth opening is reassessed.

Psychosocial factors are re-evaluated through questionnaires, including the Jaw Functional Limitation Scale (JFLS) and Graded Chronic Pain Scale (GCPS).

5 final evaluation

A final evaluation is conducted to assess the overall effectiveness of the treatment in managing TMJ arthritis.

The presence of any degenerative bone changes is re-examined by an oral radiologist.

Who Can Join the Study?

You must be at least 18 years old.
You must have arthritis in the temporomandibular joint (TMJ), which is the joint connecting your jaw to your skull, in one or both joints.
You need to understand Swedish both when spoken and in writing.
You must have given written consent, which means you agree in writing to participate in the study.
You should have received information about the condition and treatment involving postural exercises, which are exercises to improve your posture.

Who Cannot Join the Study?

Patients who have a different condition than arthritis of the temporomandibular joint cannot participate. This condition affects the joint that connects your jaw to your skull.
Patients who are not within the specified age range cannot participate. The age range includes both children and adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

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Site Name	City	Country	Status
Vaestra Goetalandsregionen	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.05.2024

Trial locations

Investigated Drugs:

Cortisone Injection
Cortisone is a type of corticosteroid medication used to reduce inflammation and relieve pain. In this trial, cortisone is injected directly into the temporomandibular joint (TMJ) to help manage arthritis symptoms by decreasing swelling and discomfort in the joint.

Arthrocentesis
Arthrocentesis is a procedure used to treat joint conditions by removing excess fluid from the joint space. In this trial, it is used as a therapy for TMJ arthritis. The procedure helps to relieve pressure, reduce pain, and improve joint movement by flushing out inflammatory substances from the joint.

Investigated Diseases:

Osteoarthritis

Arthritis of the temporomandibular joint – This condition involves inflammation of the temporomandibular joint (TMJ), which connects the jaw to the skull. It can lead to pain, swelling, and stiffness in the jaw area, making it difficult to open and close the mouth. Over time, the inflammation may cause changes in the joint structure, potentially leading to reduced mobility and function. Individuals with this condition might experience discomfort while chewing or speaking. The progression of symptoms can vary, with some experiencing intermittent flare-ups and others having more persistent issues.

Trial ID:

2023-509114-11-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Corticosteroid Injection and Arthrocentesis for Temporomandibular Joint Arthritis in Patients Using Methylprednisolone Acetate and Lidocaine Hydrochloride

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?