Phase 2
N=24
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01770912 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks — -1; -2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lactated Ringers (Drug); Triamcinolone hexacetonide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks |
-1; -2 | — |
| SECONDARY Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks |
-1; -2 | — |
| SECONDARY Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks |
-1; -2 | — |
| SECONDARY Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks |
3.9; 9.7 | — |
| SECONDARY Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks |
6.9; 7.4 | — |
| SECONDARY Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks |
5.3; 10.0 | — |
| SECONDARY Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks |
-2; -1 | — |
| SECONDARY Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks |
-1; -1 | — |
| SECONDARY Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks |
0; -2 | — |
| SECONDARY Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks |
1; 5 | — |
| SECONDARY Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks |
3; 6 | — |
| SECONDARY Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks |
4; 5 | — |
| SECONDARY Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks |
-30; -37 | — |
| SECONDARY Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks |
-33; -47 | — |
| SECONDARY Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks |
-26; -43 | — |
Summary
The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment.
All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.
Eligibility Criteria
Inclusion Criteria
- Female
- 18-80 years of age
- TMJ arthralgia
- Masticatory myalgia
- TMJ sounds
- History of at least 6 weeks use of occlusal appliance therapy
Exclusion Criteria
- Contraindication to sedation including pregnancy or medical history
- History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
- History of steroidal injection into TMJ
- History of trauma to TMJ
- TMJ pain longer than 3 years
- History of narcotic drug use on a scheduled basis
- Current active infection
Data sourced from ClinicalTrials.gov (NCT01770912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.