Osteoarthritis, TMJ
Conditions
Brief summary
Temporomandibular joint (TMJ) osteoarthritis (OA) affects articulating tissues secondary to inflammation resulting in intracapsular pain. This prospective, double-blind randomized clinical trial will evaluate the relative efficacy of TMJ arthrocentesis with a supplementation of platelet-rich growth factors (PRGF) compared to TMJ arthrocentesis with a steroid supplementation (a known effective therapy) for patients with TMJ OA.
Detailed description
Temporomandibular disorders (TMD) are musculoskeletal disorders that are commonly encountered, with pain in the temporomandibular joint (TMJ) and jaw closing muscles. Pain that involves the temporomandibular joint includes inflammatory pathologies such as arthritides, painful disk displacements and many times have an overlay of psychosocial comorbidities due to the uncontrolled pain. TMJ osteoarthritis is an intracapsular condition affecting the temporomandibular joint and presents with remodeling of the TMJ articulating tissues including the condyle and articular eminence secondary to inflammation resulting in intracapsular pain. There is a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with TMJ osteoarthritis. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain and disability. The purpose of this study is to establish the relative efficacy of TMJ arthrocentesis with steroid supplementation (a known effective therapy) compared to TMJ arthrocentesis with a supplement of plasma rich in growth factors (PRGF) for patients with TMJ osteoarthritis. Plasma rich in growth factors is isolated from the patient's own blood and injected into the temporomandibular joint to activate stem cells that may restore some of the articulating tissues that were lost during degeneration changes within the joint secondary to osteoarthritis. Pain and disability will be assessed using standard pain and physical measures that are recorded before and after treatment. Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery Faculty/Resident clinic. At the first appointment, they will be examined following standard procedures (medical history, physical exam, imaging by cone beam computerized tomography (CBCT)) to determine their diagnosis(es) and if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent on the day of their TMJ arthrocentesis procedure, they will be required to have a pregnancy test if below age 60 and complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. The patients will then undergo the standard clinical protocol for TMJ arthrocentesis followed by either a 2 cc steroid/bupivacaine hydrochloride supplementation (standard treatment group) or a 2 cc PRGF supplementation (experimental group) into the TMJ. Follow-up appointments will be conducted at 1 month, 3 months and 6 months when the pain VAS measures and a clinical exam will be assessed. If patients have not experienced improvement in their primary outcome measure (TMJ pain) at the 3 month evaluation, the patient will have a second TMJ arthrocentesis procedure that will be supplemented with the alternative medication/growth factors (steroid or PRGF) using a cross-over design. Data from these patients will be analyzed separately from patients that complete the six month study. Also at 6 months, a second CBCT image of the temporomandibular joints will be obtained to determine the extent of bone remodeling within the TMJ. The results of this study should provide new information on the efficacy of PRGF supplementation for management of temporomandibular joint osteoarthritis.
Interventions
BIOLOGICALPlasma Rich in Growth Factor (PRGF) Supplementation
After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes.
DRUGTriamcinolone Acetonide
After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female * 40 - 80 years of age * Unilateral or bilateral TMJ arthralgia * Osteoarthritis diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) * TMJ sounds (crepitus or click or both) * Mild-moderate masticatory muscle myalgia * History of non-surgical treatment for at least 6 weeks including such modalities as appliance therapy, NSAID therapy or physical modalities without resolution of pain
Exclusion criteria
* Contraindication to sedation including pregnancy or medical history * Rheumatologic disorders causing arthritis of the temporomandibular joint (i.e., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) * History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy * History of steroid injection in TMJ * TMJ pain greater than five years * History of narcotic drug use on a scheduled basis * Current active infection * Fibromyalgia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | Three Months | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as no pain and 100 is represented as the most intense pain imaginable. Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chewing Pain Measured by Visual Analog Scale (VAS) | Baseline | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as no pain and 100 is represented as the most intense pain imaginable. Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). |
| Temporomandibular Joint Crepitus | Baseline | Presence of multiple, distinct joint sounds (crepitus). |
Countries
United States
Participant flow
Recruitment details
Recruitment period: 02-17-2021 to 02-21-2024 Study location: Oral and Maxillofacial Surgery Clinic
Participants by arm
| Arm | Count |
|---|---|
| PRGF Arm The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.
Plasma Rich in Growth Factor (PRGF) Supplementation: After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes. | 4 |
| Steroid Arm Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.
Triamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine. | 1 |
| Total | 5 |
Baseline characteristics
| Characteristic | PRGF Arm | Steroid Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Temporomandibular Joint (TMJ) Intracapsular Pain-Visual Analog Scale (VAS) Rating | 67.5 units on a scale STANDARD_DEVIATION 27.5 | 90.0 units on a scale STANDARD_DEVIATION 0 | 78.6 units on a scale STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 1 |
| other Total, other adverse events | 0 / 4 | 0 / 1 |
| serious Total, serious adverse events | 0 / 4 | 0 / 1 |
Outcome results
Primary
Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating
The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as no pain and 100 is represented as the most intense pain imaginable. Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).
Time frame: Three Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRGF Arm | Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | 25.0 units on a scale | Standard Deviation 50 |
| Steroid Arm | Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | 90.0 units on a scale | Standard Deviation 0 |
Primary
Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating
The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as no pain and 100 is represented as the most intense pain imaginable. Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).
Time frame: Six Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRGF Arm | Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | 0.0 units on a scale | Standard Error 0 |
| Steroid Arm | Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | 80.0 units on a scale | Standard Error 0 |
Other Pre-specified
Chewing Pain Measured by Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as no pain and 100 is represented as the most intense pain imaginable. Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRGF Arm | Chewing Pain Measured by Visual Analog Scale (VAS) | 80.25 units on a scale | Standard Deviation 11.7 |
| Steroid Arm | Chewing Pain Measured by Visual Analog Scale (VAS) | 78.6 units on a scale | Standard Deviation 10.8 |
Other Pre-specified
Chewing Pain Measured by Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as no pain and 100 is represented as the most intense pain imaginable. Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain).
Time frame: Six Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRGF Arm | Chewing Pain Measured by Visual Analog Scale (VAS) | 2.25 units on a scale | Standard Deviation 4.5 |
| Steroid Arm | Chewing Pain Measured by Visual Analog Scale (VAS) | 42 units on a scale | Standard Deviation 0 |
Other Pre-specified
Temporomandibular Joint Crepitus
Presence of multiple, distinct joint sounds (crepitus).
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRGF Arm | Temporomandibular Joint Crepitus | 3 Participants |
| Steroid Arm | Temporomandibular Joint Crepitus | 0 Participants |
Other Pre-specified
Temporomandibular Joint Crepitus
Presence of multiple, distinct joint sounds (crepitus).
Time frame: Six Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRGF Arm | Temporomandibular Joint Crepitus | TMJ Crepitus Present | 3 Participants |
| PRGF Arm | Temporomandibular Joint Crepitus | No TMJ Sound | 1 Participants |
| Steroid Arm | Temporomandibular Joint Crepitus | TMJ Crepitus Present | 0 Participants |
| Steroid Arm | Temporomandibular Joint Crepitus | No TMJ Sound | 1 Participants |