Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01524913
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Collaborators:
University of California, Los Angeles
Oregon Health and Science University
University of Minnesota
University of Cincinnati
University of Pennsylvania
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Temporomandibular Joint Dysfunction
Pain
Arthrocentesis
Interventions Drug: Hyaluronic acid
Drug: Corticosteroid
Drug: Lactated Ringers
Enrollment 102
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.
Arm/Group Title Corticosteroid Hyaluronic Acid Saline Placebo
Hide Arm/Group Description Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space. Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space. Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space.
Period Title: Overall Study
Started 35 36 31
Completed 31 36 31
Not Completed 4 0 0
Reason Not Completed
Lost to Follow-up             4             0             0
Arm/Group Title Corticosteroid Hyaluronic Acid Saline Placebo Total
Hide Arm/Group Description Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space. Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space. Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space. Total of all reporting groups
Overall Number of Baseline Participants 35 36 31 102
Hide Baseline Analysis Population Description
The Baseline Analysis Population includes all participants who met eligibility criteria, were randomized to a study arm, and received their assigned study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 36 participants 31 participants 102 participants
39.6  (18.4) 44.3  (17.2) 51.8  (17.2) 45.0  (18.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Female
31
  88.6%
30
  83.3%
28
  90.3%
89
  87.3%
Male
4
  11.4%
6
  16.7%
3
   9.7%
13
  12.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
African American
6
  17.1%
7
  19.4%
6
  19.4%
19
  18.6%
White
25
  71.4%
28
  77.8%
23
  74.2%
76
  74.5%
Asian
1
   2.9%
0
   0.0%
1
   3.2%
2
   2.0%
Other
3
   8.6%
1
   2.8%
1
   3.2%
5
   4.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 36 participants 31 participants 102 participants
35 36 31 102
Headache  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
19
  54.3%
17
  47.2%
16
  51.6%
52
  51.0%
No
16
  45.7%
19
  52.8%
15
  48.4%
50
  49.0%
Migraine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
12
  34.3%
9
  25.0%
7
  22.6%
28
  27.5%
No
23
  65.7%
27
  75.0%
24
  77.4%
74
  72.5%
Prior TMJ Surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
5
  14.3%
4
  11.1%
1
   3.2%
10
   9.8%
No
30
  85.7%
32
  88.9%
30
  96.8%
92
  90.2%
Capsular Pain  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
26
  74.3%
28
  77.8%
24
  77.4%
78
  76.5%
No
9
  25.7%
8
  22.2%
7
  22.6%
24
  23.5%
Myofascial Pain  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
15
  42.9%
24
  66.7%
20
  64.5%
59
  57.8%
No
20
  57.1%
12
  33.3%
11
  35.5%
43
  42.2%
Cervical Pain  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
11
  31.4%
13
  36.1%
9
  29.0%
33
  32.4%
No
24
  68.6%
23
  63.9%
22
  71.0%
69
  67.6%
Clicking Jaw  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
14
  40.0%
14
  38.9%
9
  29.0%
37
  36.3%
No
21
  60.0%
22
  61.1%
22
  71.0%
65
  63.7%
Crepitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 31 participants 102 participants
Yes
5
  14.3%
6
  16.7%
2
   6.5%
13
  12.7%
No
30
  85.7%
30
  83.3%
29
  93.5%
89
  87.3%
1.Primary Outcome
Title Change in Pain Between Baseline and Month 1 Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Corticosteroid Hyaluronic Acid Saline Placebo
Hide Arm/Group Description:
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
Overall Number of Participants Analyzed 31 36 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change in Pain - Right Side -1.1  (2.8) -1.7  (3.0) -2.6  (2.8)
Change in Pain - Left Side -2.0  (3.1) -2.1  (3.1) -2.3  (3.2)
2.Secondary Outcome
Title Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Corticosteroid Hyaluronic Acid Saline Placebo
Hide Arm/Group Description:
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
Overall Number of Participants Analyzed 35 36 31
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline MIO without pain Number Analyzed 35 participants 36 participants 31 participants
28.3  (8.4) 27.9  (11.2) 25.7  (7.5)
Baseline MIO maximum Number Analyzed 35 participants 36 participants 31 participants
37.0  (8.5) 33.9  (10.3) 34.1  (7.8)
Month 1 MIO without pain Number Analyzed 31 participants 36 participants 31 participants
35.0  (9.4) 31.7  (11.4) 29.6  (10.6)
Month 1 MIO maximum Number Analyzed 31 participants 36 participants 31 participants
39.0  (10.5) 36.8  (11.2) 37.4  (6.7)
Month 3 MIO without pain Number Analyzed 19 participants 17 participants 15 participants
36.1  (11.3) 33.9  (11.7) 35.7  (5.0)
Month 3 MIO maximum Number Analyzed 19 participants 17 participants 15 participants
37.8  (15.0) 38.3  (13.2) 39.3  (5.3)
3.Secondary Outcome
Title Jaw Function Limitation Scale (JFLS) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Corticosteroid Hyaluronic Acid Saline Placebo
Hide Arm/Group Description:
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
Overall Number of Participants Analyzed 31 36 31
Measure Type: Count of Participants
Unit of Measure: Participants
None
3
   9.7%
5
  13.9%
6
  19.4%
Mild
18
  58.1%
14
  38.9%
14
  45.2%
Moderate
9
  29.0%
14
  38.9%
9
  29.0%
Severe
1
   3.2%
3
   8.3%
2
   6.5%
4.Secondary Outcome
Title Jaw Function Limitation Scale (JFLS) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Corticosteroid Hyaluronic Acid Saline Placebo
Hide Arm/Group Description:
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
Overall Number of Participants Analyzed 19 17 15
Measure Type: Count of Participants
Unit of Measure: Participants
None
5
  26.3%
5
  29.4%
6
  40.0%
Mild
8
  42.1%
7
  41.2%
5
  33.3%
Moderate
5
  26.3%
4
  23.5%
4
  26.7%
Severe
1
   5.3%
1
   5.9%
0
   0.0%
Time Frame 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 Event Reporting Description 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.
 
Arm/Group Title Corticosteroid Hyaluronic Acid Saline Placebo
Hide Arm/Group Description Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space. Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space. Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
All-Cause Mortality
Corticosteroid Hyaluronic Acid Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Corticosteroid Hyaluronic Acid Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/36 (0.00%)   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Corticosteroid Hyaluronic Acid Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/36 (0.00%)   0/31 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Bouloux, MD, DDS
Organization: Emory University
Phone: 404-778-4500
EMail: gfboulo@emory.edu
Layout table for additonal information
Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
ClinicalTrials.gov Identifier: NCT01524913    
Other Study ID Numbers: IRB00018682
Arthrocentesis ( Other Identifier: Other )
First Submitted: January 29, 2012
First Posted: February 2, 2012
Results First Submitted: January 12, 2017
Results First Posted: May 5, 2017
Last Update Posted: May 5, 2017