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| ID | Type | Description | Link |
|---|---|---|---|
| Arthrocentesis | Other Identifier | Other |
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Oregon Health and Science University | OTHER |
| University of Minnesota | OTHER |
| University of Cincinnati |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid | Experimental |
| |
| Corticosteroid | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid | Drug | 1 cc hyalgan to be injected into superior joint space |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (preoperation), Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (preoperation), Month 1, Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
myofascial 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
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| Name | Affiliation | Role |
|---|---|---|
| Gary F Bouloux, MD, DDS | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University California Los Angeles | Los Angeles | California | 90024 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27632069 | Result | Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1. J Oral Maxillofac Surg. 2017 Jan;75(1):52-62. doi: 10.1016/j.joms.2016.08.006. Epub 2016 Aug 20. | |
| 27632067 |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid | Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space. |
| FG001 | Hyaluronic Acid | Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OTHER |
| University of Pennsylvania | OTHER |
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| Corticosteroid |
| Drug |
1cc celestone (6 mg/cc) will be injected into the joint space |
|
| Lactated Ringers | Drug | 1 cc lactated ringers solution will be injected into the joint space |
|
| 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). |
| Month 1 |
| 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). | Month 3 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Cinncinati | Cinncinati | Ohio | 45219 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short Term for Improving Function and Quality of Life After Arthrocentesis? Part 2. J Oral Maxillofac Surg. 2017 Jan;75(1):63-72. doi: 10.1016/j.joms.2016.08.008. Epub 2016 Aug 20. |
| FG002 | Saline Placebo | Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Baseline Analysis Population includes all participants who met eligibility criteria, were randomized to a study arm, and received their assigned study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Corticosteroid | Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space. |
| BG001 | Hyaluronic Acid | Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space. |
| BG002 | Saline Placebo | Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Headache | Count of Participants | Participants |
| ||||||||||||||||
| Migraine | Count of Participants | Participants |
| ||||||||||||||||
| Prior TMJ Surgery | Count of Participants | Participants |
| ||||||||||||||||
| Capsular Pain | Count of Participants | Participants |
| ||||||||||||||||
| Myofascial Pain | Count of Participants | Participants |
| ||||||||||||||||
| Cervical Pain | Count of Participants | Participants |
| ||||||||||||||||
| Clicking Jaw | Count of Participants | Participants |
| ||||||||||||||||
| Crepitus | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (preoperation), Month 1 |
|
|
| ||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | millimeters | Baseline (preoperation), Month 1, Month 3 |
| ||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Count of Participants | Participants | Month 1 |
| |||||||||||||||||||||||||||||||||||
| 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). | 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). | Posted | Count of Participants | Participants | Month 3 |
|
Adverse events were assessed up to three months after arthrocentesis. Allergic reactions were watched for during the procedure and during the 30 minute recovery period after the procedure. Post injection flare was monitored after 1 month. All other adverse events were monitored during for three months post-procedure.
Adverse events were actively sought, including allergic reactions (anaphylaxis, angioedema, urticaria), post-injection flare, hospital admission, the need for additional procedures to prevent or limit permanent injury, and death and other life threatening events. Given the extensive safe track record of hyaluronic acid and the corticosteroid Celestone, no adverse events were expected to occur.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Corticosteroid | Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space. | 0 | 35 | 0 | 35 | ||
| EG001 | Hyaluronic Acid | Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space. | 0 | 36 | 0 | 36 | ||
| EG002 | Saline Placebo | Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space. | 0 | 31 | 0 | 31 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Bouloux, MD, DDS | Emory University | 404-778-4500 | gfboulo@emory.edu |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D000305 | Adrenal Cortex Hormones |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Male |
|
| White |
|
| Asian |
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| Other |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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