Trial Outcomes & Findings for Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management (NCT NCT01770912)
NCT ID: NCT01770912
Last Updated: 2020-10-08
Results Overview
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
COMPLETED
PHASE2
24 participants
Baseline and 12 weeks post-treatment
2020-10-08
Participant Flow
Subjects were recruited from 2013-2018 from facial pain referrals to the Oral and Maxillofacial Surgery Clinic.
Participant milestones
| Measure |
Lactated Ringers
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Lactated Ringers
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
Baseline characteristics by cohort
| Measure |
Lactated Ringers
n=12 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 17.5 • n=93 Participants
|
52.7 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
48.0 years
STANDARD_DEVIATION 18.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Temporomandibular Joint Loading Pain
|
2 units on a scale
n=93 Participants
|
2 units on a scale
n=4 Participants
|
2 units on a scale
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeks post-treatmentTMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks
|
-1 units on a scale
Interval -2.0 to 0.0
|
-2 units on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks post-treatmentTMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks
|
-1 units on a scale
Interval -3.0 to 0.0
|
-2 units on a scale
Interval -3.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks post-treatmentTMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks
|
-1 units on a scale
Interval -2.0 to 2.0
|
-2 units on a scale
Interval -3.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks post-treatmentMandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks
|
3.9 mm
Standard Error 2.4
|
9.7 mm
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks post-treatmentMandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks
|
6.9 mm
Standard Error 2.8
|
7.4 mm
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks post-treatmentMandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks
|
5.3 mm
Standard Error 2.1
|
10.0 mm
Standard Error 3.3
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks post-treatmentPalpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks
|
-2 units on a scale
Interval -16.0 to 7.0
|
-1 units on a scale
Interval -5.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks post-treatmentPalpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks
|
-1 units on a scale
Interval -16.0 to 3.0
|
-1 units on a scale
Interval -5.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks post-treatmentPalpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks
|
0 units on a scale
Interval -16.0 to 5.0
|
-2 units on a scale
Interval -5.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks post-treatmentOpening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks post-treatmentOpening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks post-treatmentOpening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and 2 weeks post-treatmentPain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks
|
-30 units on a scale
Standard Error 6.1
|
-37 units on a scale
Standard Error 7.3
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks post-treatmentPain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks
|
-33 units on a scale
Standard Error 7.8
|
-47 units on a scale
Standard Error 9.2
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks post-treatmentPain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".
Outcome measures
| Measure |
Lactated Ringers
n=10 Participants
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
Lactated Ringers: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Triamcinolone Acetonide
n=12 Participants
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
Triamcinolone acetonide: 1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
|---|---|---|
|
Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks
|
-26 units on a scale
Standard Error 9.6
|
-43 units on a scale
Standard Error 8.7
|
Adverse Events
Lactated Ringers
Triamcinolone Acetonide
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Charles G. Widmer, Associate Professor
University of Florida
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place