Trial Outcomes & Findings for A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction (NCT NCT01524913)
NCT ID: NCT01524913
Last Updated: 2017-05-05
Results Overview
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.
COMPLETED
PHASE4
102 participants
Baseline (preoperation), Month 1
2017-05-05
Participant Flow
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.
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.
Participant milestones
| Measure |
Corticosteroid
Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space.
|
Hyaluronic Acid
Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space.
|
Saline Placebo
Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space.
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
31
|
|
Overall Study
COMPLETED
|
31
|
36
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Corticosteroid
Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space.
|
Hyaluronic Acid
Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space.
|
Saline Placebo
Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
0
|
Baseline Characteristics
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
Baseline characteristics by cohort
| Measure |
Corticosteroid
n=35 Participants
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
|
Hyaluronic Acid
n=36 Participants
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
|
Saline Placebo
n=31 Participants
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 18.4 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
31 participants
n=5 Participants
|
102 participants
n=4 Participants
|
|
Headache
Yes
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Headache
No
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Migraine
Yes
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Migraine
No
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Prior TMJ Surgery
Yes
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Prior TMJ Surgery
No
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Capsular Pain
Yes
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Capsular Pain
No
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Myofascial Pain
Yes
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Myofascial Pain
No
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Cervical Pain
Yes
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Cervical Pain
No
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Clicking Jaw
Yes
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Clicking Jaw
No
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Crepitus
Yes
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Crepitus
No
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (preoperation), Month 1Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid
n=31 Participants
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
|
Hyaluronic Acid
n=36 Participants
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
|
Saline Placebo
n=31 Participants
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
|
|---|---|---|---|
|
Change in Pain Between Baseline and Month 1 Scores
Change in Pain - Left Side
|
-2.0 units on a scale
Standard Deviation 3.1
|
-2.1 units on a scale
Standard Deviation 3.1
|
-2.3 units on a scale
Standard Deviation 3.2
|
|
Change in Pain Between Baseline and Month 1 Scores
Change in Pain - Right Side
|
-1.1 units on a scale
Standard Deviation 2.8
|
-1.7 units on a scale
Standard Deviation 3.0
|
-2.6 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline (preoperation), Month 1, Month 3Population: 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.
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.
Outcome measures
| Measure |
Corticosteroid
n=35 Participants
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
|
Hyaluronic Acid
n=36 Participants
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
|
Saline Placebo
n=31 Participants
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
|
|---|---|---|---|
|
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Baseline MIO maximum
|
37.0 millimeters
Standard Deviation 8.5
|
33.9 millimeters
Standard Deviation 10.3
|
34.1 millimeters
Standard Deviation 7.8
|
|
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
|
31.7 millimeters
Standard Deviation 11.4
|
29.6 millimeters
Standard Deviation 10.6
|
|
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Month 3 MIO maximum
|
37.8 millimeters
Standard Deviation 15.0
|
38.3 millimeters
Standard Deviation 13.2
|
39.3 millimeters
Standard Deviation 5.3
|
|
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Baseline MIO without pain
|
28.3 millimeters
Standard Deviation 8.4
|
27.9 millimeters
Standard Deviation 11.2
|
25.7 millimeters
Standard Deviation 7.5
|
|
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Month 1 MIO maximum
|
39.0 millimeters
Standard Deviation 10.5
|
36.8 millimeters
Standard Deviation 11.2
|
37.4 millimeters
Standard Deviation 6.7
|
|
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
|
33.9 millimeters
Standard Deviation 11.7
|
35.7 millimeters
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Month 1Population: 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.
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).
Outcome measures
| Measure |
Corticosteroid
n=31 Participants
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
|
Hyaluronic Acid
n=36 Participants
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
|
Saline Placebo
n=31 Participants
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
|
|---|---|---|---|
|
Jaw Function Limitation Scale (JFLS) Score
None
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Jaw Function Limitation Scale (JFLS) Score
Mild
|
18 Participants
|
14 Participants
|
14 Participants
|
|
Jaw Function Limitation Scale (JFLS) Score
Moderate
|
9 Participants
|
14 Participants
|
9 Participants
|
|
Jaw Function Limitation Scale (JFLS) Score
Severe
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Month 3Population: 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).
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).
Outcome measures
| Measure |
Corticosteroid
n=19 Participants
Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
|
Hyaluronic Acid
n=17 Participants
Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
|
Saline Placebo
n=15 Participants
Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
|
|---|---|---|---|
|
Jaw Function Limitation Scale (JFLS) Score
Moderate
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Jaw Function Limitation Scale (JFLS) Score
None
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Jaw Function Limitation Scale (JFLS) Score
Mild
|
8 Participants
|
7 Participants
|
5 Participants
|
|
Jaw Function Limitation Scale (JFLS) Score
Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Corticosteroid
Hyaluronic Acid
Saline Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place