Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint

Phase 1

Withdrawn

• Conditions: Degenerative Joint Disease
• Interventions: Drug: Group A (corticosteroid injection group); Biological: Group B (platelet rich plasma injection group)

• Registration Number: NCT01920373
• Lead Sponsor: Kaiser Permanente

Brief Summary

1.0 BACKGROUND AND HYPOTHESES

1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint.

1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function. Similarly, platelet rich plasma has shown to have better outcomes than corticosteroid injections in the management of lateral epicondylitis, and better outcomes than hyaluronic acid injections in the management of osteochondral lesions of the talus.

1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are focused primarily on palliation by reducing inflammation and inflammatory mediators. This study seeks to validate a therapeutic agent that has the potential to actively prevent the progression of degeneration in addition to reducing pain and inflammation

Detailed Description

2.0 OBJECTIVES AND PURPOSE

2.1 The purpose of this study is to compare the efficacy, in terms of pain relief and improvement in function, of intra-articular injections with platelet rich plasma versus the current standard which is corticosteroid injections into the temporomandibular joint.

Study Timeline

• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-12
• Study Start: 2013-11
• Primary Completion: 2013-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The following diagnostic criteria for patient selection are to be used:

• Patients will need to have a history of chronic pain (at least 3 months) refractory to conservative therapy with non-steroidal anti-inflammatory medications, muscle relaxants, diet modifications and splint therapy
• Patients will also need to have imaging findings (radiography or magnetic resonance imaging) that show mild to severe degenerative changes of the temporomandibular joint

Exclusion Criteria

Exclusion criteria will include

• Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression
• Patients receiving therapy with anticoagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (corticosteroid injection group)	Group A (corticosteroid injection group)	Group A will receive one intra-articular injection of 2 ml of solution containing 1ml of 10mg/ml Triamcinolone suspended in 1 ml of 0.5% Bupivacaine solution per affected joint
Group B (platelet rich plasma injection)	Group B (platelet rich plasma injection group)	Group B will receive a 2 ml intra-articular injection of a platelet rich plasma preparation per affected joint

Primary Outcome Measures

Name	Time	Method
Pain relief	24 weeks	Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.

Secondary Outcome Measures

Name	Time	Method
Improvement in function	24 weeks	The patients improvement in function will be evaluated at 1,3, and 6 months for improvement using the pain resource centers TMJ scale.

Trial Locations

Locations (1)

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States