Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/27/2019 |
| Start Date: | March 2013 |
| End Date: | January 24, 2019 |
A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis
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.
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.
Temporomandibular joint disorders are common and poorly understood in terms of etiology and
pathogenesis. These disorders are multifactorial in origin including physical and
psychosocial aspects; however, there is little understanding as to how much each of these
components are associated with a particular diagnosis and subsequent treatment outcome of
temporomandibular joint disorders. There is also a paucity of information regarding the
relative effectiveness of different therapies for the treatment of patients with
temporomandibular joint disorders. The identification of the least invasive and most
efficacious therapy is vital to proper management of these patients with temporomandibular
joint pain.
Patients enrolled into the study will be examined and treated at the Department of Oral and
Maxillofacial Surgery. At the first appointment, they will be examined following standard
procedures to determine if they would potentially benefit from the TMJ arthrocentesis
procedure. If the patient meets the inclusion criteria for the study and with their informed
consent, they will be required to complete a questionnaire about their physical and pain
symptoms and undergo a standardized clinical exam. At the next appointment, the patients will
undergo the standard clinical protocol for TMJ arthrocentesis with either only normal saline
or normal saline with adjunctive steroids (triamcinolone hexacetonide). Follow-up
appointments will be at 2 weeks, 6 weeks and 12 weeks where the pain VAS and clinical exams
will be completed.
pathogenesis. These disorders are multifactorial in origin including physical and
psychosocial aspects; however, there is little understanding as to how much each of these
components are associated with a particular diagnosis and subsequent treatment outcome of
temporomandibular joint disorders. There is also a paucity of information regarding the
relative effectiveness of different therapies for the treatment of patients with
temporomandibular joint disorders. The identification of the least invasive and most
efficacious therapy is vital to proper management of these patients with temporomandibular
joint pain.
Patients enrolled into the study will be examined and treated at the Department of Oral and
Maxillofacial Surgery. At the first appointment, they will be examined following standard
procedures to determine if they would potentially benefit from the TMJ arthrocentesis
procedure. If the patient meets the inclusion criteria for the study and with their informed
consent, they will be required to complete a questionnaire about their physical and pain
symptoms and undergo a standardized clinical exam. At the next appointment, the patients will
undergo the standard clinical protocol for TMJ arthrocentesis with either only normal saline
or normal saline with adjunctive steroids (triamcinolone hexacetonide). Follow-up
appointments will be at 2 weeks, 6 weeks and 12 weeks where the pain VAS and clinical exams
will be completed.
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
We found this trial at
1
site
Gainesville, Florida 32610
Principal Investigator: Charles G. Widmer, DDS, MS
Phone: 352-273-5801
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