Pain
Conditions
Keywords
facial pain, temporomandibular joint, arthrocentesis, steroid
Brief 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.
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.
Interventions
DRUGLactated Ringers
Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks | Baseline and 12 weeks post-treatment | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | Baseline and 6 weeks post-treatment | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). |
| Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | 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. |
| Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | 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. |
| Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks | 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. |
| Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks | 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. |
| Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks | 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. |
| Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | Baseline and 2 weeks post-treatment | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). |
| Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks | 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. |
| Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks | 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. |
| Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks | 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. |
| Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks | 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. |
| Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks | 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. |
| Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks | 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. |
| Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 2013-2018 from facial pain referrals to the Oral and Maxillofacial Surgery Clinic.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Lactated Ringers | Triamcinolone Acetonide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Continuous | 43.3 years STANDARD_DEVIATION 17.5 | 52.7 years STANDARD_DEVIATION 18.1 | 48.0 years STANDARD_DEVIATION 18.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 11 Participants | 23 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Temporomandibular Joint Loading Pain | 2 units on a scale | 2 units on a scale | 2 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Time frame: Baseline and 12 weeks post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactated Ringers | Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks | -1 units on a scale |
| Triamcinolone Acetonide | Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks | -2 units on a scale |
Secondary
Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks
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.
Time frame: Baseline and 12 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactated Ringers | Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks | -26 units on a scale | Standard Error 9.6 |
| Triamcinolone Acetonide | Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks | -43 units on a scale | Standard Error 8.7 |
Secondary
Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks
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.
Time frame: Baseline and 2 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactated Ringers | Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks | -30 units on a scale | Standard Error 6.1 |
| Triamcinolone Acetonide | Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks | -37 units on a scale | Standard Error 7.3 |
Secondary
Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks
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.
Time frame: Baseline and 6 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactated Ringers | Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks | -33 units on a scale | Standard Error 7.8 |
| Triamcinolone Acetonide | Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks | -47 units on a scale | Standard Error 9.2 |
Secondary
Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks
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.
Time frame: Baseline and 6 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactated Ringers | Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | 6.9 mm | Standard Error 2.8 |
| Triamcinolone Acetonide | Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | 7.4 mm | Standard Error 2.9 |
Secondary
Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks
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.
Time frame: Baseline and 2 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactated Ringers | Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | 3.9 mm | Standard Error 2.4 |
| Triamcinolone Acetonide | Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | 9.7 mm | Standard Error 2.6 |
Secondary
Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks
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.
Time frame: Baseline and 12 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactated Ringers | Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks | 5.3 mm | Standard Error 2.1 |
| Triamcinolone Acetonide | Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks | 10.0 mm | Standard Error 3.3 |
Secondary
Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Time frame: Baseline and 2 weeks post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactated Ringers | Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | -1 units on a scale |
| Triamcinolone Acetonide | Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | -2 units on a scale |
Secondary
Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Time frame: Baseline and 6 weeks post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactated Ringers | Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | -1 units on a scale |
| Triamcinolone Acetonide | Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | -2 units on a scale |
Secondary
Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks
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.
Time frame: Baseline and 12 weeks post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactated Ringers | Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks | 0 units on a scale |
| Triamcinolone Acetonide | Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks | -2 units on a scale |
Secondary
Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks
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.
Time frame: Baseline and 2 weeks post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactated Ringers | Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks | -2 units on a scale |
| Triamcinolone Acetonide | Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks | -1 units on a scale |
Secondary
Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks
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.
Time frame: Baseline and 6 weeks post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactated Ringers | Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks | -1 units on a scale |
| Triamcinolone Acetonide | Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks | -1 units on a scale |
Secondary
Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Time frame: Baseline and 12 weeks post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactated Ringers | Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks | 4 Participants |
| Triamcinolone Acetonide | Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks | 5 Participants |
Secondary
Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Time frame: Baseline and 2 weeks post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactated Ringers | Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks | 1 Participants |
| Triamcinolone Acetonide | Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks | 5 Participants |
Secondary
Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks
Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.
Time frame: Baseline and 6 weeks post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactated Ringers | Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks | 3 Participants |
| Triamcinolone Acetonide | Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks | 6 Participants |