- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01770912
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida College of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Lactated Ringers
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
Solution used for TMJ arthrocentesis procedure.
1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
|
ACTIVE_COMPARATOR: Triamcinolone acetonide
1 cc of triamcinolone acetonide (20 mg) injected once after the TMJ rinsing procedure.
|
1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks
Time Frame: Baseline and 12 weeks post-treatment
|
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
|
Baseline and 12 weeks post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks
Time Frame: Baseline and 2 weeks post-treatment
|
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
|
Baseline and 2 weeks post-treatment
|
Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks
Time Frame: Baseline and 6 weeks post-treatment
|
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
|
Baseline and 6 weeks post-treatment
|
Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks
Time Frame: Baseline and 2 weeks post-treatment
|
Mandibular 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.
|
Baseline and 2 weeks post-treatment
|
Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks
Time Frame: Baseline and 6 weeks post-treatment
|
Mandibular 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.
|
Baseline and 6 weeks post-treatment
|
Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks
Time Frame: Baseline and 12 weeks post-treatment
|
Mandibular 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.
|
Baseline and 12 weeks post-treatment
|
Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks
Time Frame: Baseline and 2 weeks post-treatment
|
Palpable 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.
|
Baseline and 2 weeks post-treatment
|
Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks
Time Frame: Baseline and 6 weeks post-treatment
|
Palpable 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.
|
Baseline and 6 weeks post-treatment
|
Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks
Time Frame: Baseline and 12 weeks post-treatment
|
Palpable 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.
|
Baseline and 12 weeks post-treatment
|
Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks
Time Frame: Baseline and 2 weeks post-treatment
|
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
|
Baseline and 2 weeks post-treatment
|
Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks
Time Frame: Baseline and 6 weeks post-treatment
|
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
|
Baseline and 6 weeks post-treatment
|
Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks
Time Frame: Baseline and 12 weeks post-treatment
|
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
|
Baseline and 12 weeks post-treatment
|
Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks
Time Frame: Baseline and 2 weeks post-treatment
|
Pain 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".
|
Baseline and 2 weeks post-treatment
|
Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks
Time Frame: Baseline and 6 weeks post-treatment
|
Pain 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".
|
Baseline and 6 weeks post-treatment
|
Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks
Time Frame: Baseline and 12 weeks post-treatment
|
Pain 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".
|
Baseline and 12 weeks post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles G. Widmer, DDS, MS, University of Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- IRB201600060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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