Temporomandibular Joint Dysfunction, Pain, Arthrocentesis
Conditions
Brief summary
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function. The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
Detailed description
This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.
Interventions
DRUGHyaluronic acid
1 cc hyalgan to be injected into superior joint space
DRUGCorticosteroid
1cc celestone (6 mg/cc) will be injected into the joint space
DRUGLactated Ringers
1 cc lactated ringers solution will be injected into the joint space
Sponsors
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota
University of Cincinnati
University of Pennsylvania
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* age greater than 18 years * arthralgia of one or both temporomandibular joints * Wilkes II to IV internal derangement of the symptomatic joint OR * limited opening of \<35 mm
Exclusion criteria
* myofascial pain as the primary source of pain * cervical pain as the primary source of pain * systemic arthropathy * fibromyalgia * use of NSAIDS within 48 hours * allergy to study medications * edentulous subjects * pregnancy or breast feeding * current physical therapy, muscle relaxants or antiseizure medications * current use of a splint issued within last 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Between Baseline and Month 1 Scores | Baseline (preoperation), Month 1 | The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Baseline (preoperation), Month 1, Month 3 | Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain. |
| Jaw Function Limitation Scale (JFLS) Score | Month 1 | The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from patients referred to the oral and maxillary surgery services at Emory University, the University of Pennsylvania, the University of California - Los Angeles, the University of Cincinnati, and the Oregon Health Science University. All patients were referred for management of temporomandibular joint (TMJ) pain.
Pre-assignment details
A total of 105 patients were screened; three did not meet inclusion and exclusion criteria, resulting in 102 participants who were randomized and began the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space. | 35 |
| Hyaluronic Acid Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space. | 36 |
| Saline Placebo Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space. | 31 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Corticosteroid | Hyaluronic Acid | Saline Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 18.4 | 44.3 years STANDARD_DEVIATION 17.2 | 51.8 years STANDARD_DEVIATION 17.2 | 45.0 years STANDARD_DEVIATION 18.1 |
| Capsular Pain No | 9 Participants | 8 Participants | 7 Participants | 24 Participants |
| Capsular Pain Yes | 26 Participants | 28 Participants | 24 Participants | 78 Participants |
| Cervical Pain No | 24 Participants | 23 Participants | 22 Participants | 69 Participants |
| Cervical Pain Yes | 11 Participants | 13 Participants | 9 Participants | 33 Participants |
| Clicking Jaw No | 21 Participants | 22 Participants | 22 Participants | 65 Participants |
| Clicking Jaw Yes | 14 Participants | 14 Participants | 9 Participants | 37 Participants |
| Crepitus No | 30 Participants | 30 Participants | 29 Participants | 89 Participants |
| Crepitus Yes | 5 Participants | 6 Participants | 2 Participants | 13 Participants |
| Headache No | 16 Participants | 19 Participants | 15 Participants | 50 Participants |
| Headache Yes | 19 Participants | 17 Participants | 16 Participants | 52 Participants |
| Migraine No | 23 Participants | 27 Participants | 24 Participants | 74 Participants |
| Migraine Yes | 12 Participants | 9 Participants | 7 Participants | 28 Participants |
| Myofascial Pain No | 20 Participants | 12 Participants | 11 Participants | 43 Participants |
| Myofascial Pain Yes | 15 Participants | 24 Participants | 20 Participants | 59 Participants |
| Prior TMJ Surgery No | 30 Participants | 32 Participants | 30 Participants | 92 Participants |
| Prior TMJ Surgery Yes | 5 Participants | 4 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized African American | 6 Participants | 7 Participants | 6 Participants | 19 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 25 Participants | 28 Participants | 23 Participants | 76 Participants |
| Region of Enrollment United States | 35 participants | 36 participants | 31 participants | 102 participants |
| Sex: Female, Male Female | 31 Participants | 30 Participants | 28 Participants | 89 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 3 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 36 | 0 / 31 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 | 0 / 31 |
Outcome results
Primary
Change in Pain Between Baseline and Month 1 Scores
The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.
Time frame: Baseline (preoperation), Month 1
Population: The population at this time point consists of study participants who received their assigned intervention and were not lost to follow up by the Month 1 assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid | Change in Pain Between Baseline and Month 1 Scores | Change in Pain - Right Side | -1.1 units on a scale | Standard Deviation 2.8 |
| Corticosteroid | Change in Pain Between Baseline and Month 1 Scores | Change in Pain - Left Side | -2.0 units on a scale | Standard Deviation 3.1 |
| Hyaluronic Acid | Change in Pain Between Baseline and Month 1 Scores | Change in Pain - Right Side | -1.7 units on a scale | Standard Deviation 3 |
| Hyaluronic Acid | Change in Pain Between Baseline and Month 1 Scores | Change in Pain - Left Side | -2.1 units on a scale | Standard Deviation 3.1 |
| Saline Placebo | Change in Pain Between Baseline and Month 1 Scores | Change in Pain - Right Side | -2.6 units on a scale | Standard Deviation 2.8 |
| Saline Placebo | Change in Pain Between Baseline and Month 1 Scores | Change in Pain - Left Side | -2.3 units on a scale | Standard Deviation 3.2 |
Secondary
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain.
Time frame: Baseline (preoperation), Month 1, Month 3
Population: The population for MIO analysis consists of participants having a measurement at each specified time point. The decline in the number of participants over time is due to participants who were lost to follow-up as the study progressed and one participant who attended the Month 3 visit but did not provide data for the MIO assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Baseline MIO without pain | 28.3 millimeters | Standard Deviation 8.4 |
| Corticosteroid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Baseline MIO maximum | 37.0 millimeters | Standard Deviation 8.5 |
| Corticosteroid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 1 MIO without pain | 35.0 millimeters | Standard Deviation 9.4 |
| Corticosteroid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 1 MIO maximum | 39.0 millimeters | Standard Deviation 10.5 |
| Corticosteroid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 3 MIO without pain | 36.1 millimeters | Standard Deviation 11.3 |
| Corticosteroid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 3 MIO maximum | 37.8 millimeters | Standard Deviation 15 |
| Hyaluronic Acid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 3 MIO maximum | 38.3 millimeters | Standard Deviation 13.2 |
| Hyaluronic Acid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Baseline MIO without pain | 27.9 millimeters | Standard Deviation 11.2 |
| Hyaluronic Acid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 1 MIO maximum | 36.8 millimeters | Standard Deviation 11.2 |
| Hyaluronic Acid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 3 MIO without pain | 33.9 millimeters | Standard Deviation 11.7 |
| Hyaluronic Acid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Baseline MIO maximum | 33.9 millimeters | Standard Deviation 10.3 |
| Hyaluronic Acid | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 1 MIO without pain | 31.7 millimeters | Standard Deviation 11.4 |
| Saline Placebo | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Baseline MIO maximum | 34.1 millimeters | Standard Deviation 7.8 |
| Saline Placebo | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 1 MIO without pain | 29.6 millimeters | Standard Deviation 10.6 |
| Saline Placebo | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 3 MIO maximum | 39.3 millimeters | Standard Deviation 5.3 |
| Saline Placebo | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 1 MIO maximum | 37.4 millimeters | Standard Deviation 6.7 |
| Saline Placebo | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Baseline MIO without pain | 25.7 millimeters | Standard Deviation 7.5 |
| Saline Placebo | Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3 | Month 3 MIO without pain | 35.7 millimeters | Standard Deviation 5 |
Secondary
Jaw Function Limitation Scale (JFLS) Score
The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
Time frame: Month 1
Population: The population at this time point consists of study participants who received the intervention they were randomized to and were not lost to follow-up before the Month 1 visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | None | 3 Participants |
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | Mild | 18 Participants |
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | Moderate | 9 Participants |
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | Severe | 1 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | Severe | 3 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | None | 5 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | Moderate | 14 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | Mild | 14 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | Severe | 2 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | Mild | 14 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | Moderate | 9 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | None | 6 Participants |
Secondary
Jaw Function Limitation Scale (JFLS) Score
The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
Time frame: Month 3
Population: The population at this time point consists of study participants who received the intervention they were randomized to, were not lost to follow-up before the Month 3 visit, and completed assessments at the Month 3 visit (one participant did not provide JFLS data at the Month 3 time point).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | Severe | 1 Participants |
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | Moderate | 5 Participants |
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | None | 5 Participants |
| Corticosteroid | Jaw Function Limitation Scale (JFLS) Score | Mild | 8 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | Mild | 7 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | None | 5 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | Moderate | 4 Participants |
| Hyaluronic Acid | Jaw Function Limitation Scale (JFLS) Score | Severe | 1 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | Mild | 5 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | None | 6 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | Severe | 0 Participants |
| Saline Placebo | Jaw Function Limitation Scale (JFLS) Score | Moderate | 4 Participants |