A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis
Phase: PHASE2
Conditions: Pain
Sponsor: University of Florida

 
 
 
 
 
 
Study Title:  A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After 
Temporomandibular Joint Arthrocentesis 
 
 
 
 
 
ClinicalTrials.gov Number:  NCT01770912 
 
 
 
 
 
 
Document Date:  March 5, 2019 
 
 
 
 
 
 
 
 
 
 

Protocol 
 
 
1. 
Title: 
 
 
A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After 
Temporomandibular Joint Arthrocentesis 
 
 
2. 
Investigator(s):  
 
 
Principal Investigator:  Charles G. Widmer, D.D.S., M.S. 
 
Co-Principal Investigator:  M. Franklin Dolwick, D.M.D., Ph.D. 
 
Sub Investigator:  Daili Diaz, D.M.D. 
 
 
3. 
Abstract:  
 
 
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.  The purpose of this study is to establish the relative 
efficacy of TMJ arthrocentesis with normal saline versus adjunctive steroid injection using 
standard pain and physical measures that are recorded before and after treatment. 
 
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 
acetonide).  Follow-up appointments will be at 2 weeks, 6 weeks and 12 weeks where the 
pain VAS and clinical exam will be completed. 
 
 
4. 
Background: 
 
 
Temporomandibular joint (TMJ) disorders are considered to be the most common facial 
pain conditions that health professionals encounter each year and are probably the least 
understood in terms of etiology and pathogenesis of the disorders.  As such, management 
of these disorders is poorly standardized and non uniform.  One modality that has 
emerged in recent years is temporomandibular joint arthrocentesis and is a procedure that 
involves joint lavage using physiologic solutions.  This lavage is commonly performed with 
normal saline or Lactated Ringers solution and may be followed with or without adjunctive 
steroids (depending upon the training of the practitioner).  Although there are multiple case 

reports and experimental trials that have confirmed the efficacy of the TMJ arthrocentesis 
procedure, there are few studies that have established the efficacy of adjunctive steroids 
in this procedure and no studies specifically studying the use of the steroid triamcinolone 
acetonide.  This particular steroid has been found to be particularly effective in patients 
with Juvenile Rheumatoid Arthritis involving the temporomandibular joint (Stoll, et al, 
2012).  Therefore, the purpose of this study is to evaluate the efficacy of TMJ 
arthrocentesis with or without steroid supplement on well-defined patient populations that 
have pain in the temporomandibular joint.  Information collected will include pain and 
physical determinants which will be compared pre and post TMJ arthrocentesis with and 
without the use of adjunctive triamcinolone.  By conducting this study we hope to 
determine the need of adjunctive steroid use with TMJ arthrocentesis for TMJ pain. 
 
 
5. 
Specific Aims: 
 
 
To compare the resting and functional pain levels in patients with temporomandibular joint 
pain before and after temporomandibular joint arthrocentesis with placebo or 
temporomandibular joint arthrocentesis with steroid supplementation. 
 
 
6. 
Research Plan: 
 
 
Subjects will be recruited from patients referred to Dr. Frank Dolwick for potential 
temporomandibular joint arthrocentesis of one temporomandibular joint.  Determination of 
a potential subject into the study will be made at the consultation visit (1st visit) by Dr. 
Frank Dolwick (co-PI) based on the medical history, response to a questionnaire, and 
inclusion and exclusion criteria.  Each qualifying patient will be provided an explanation of 
the study by the Principal Investigator in the Oral and Maxillofacial Surgery clinic (by 
review of the Informed Consent Form) and a copy of the Informed Consent Form will be 
provided at the end of the consultation.  The second scheduled visit is the TMJ 
arthrocentesis procedure and Informed Consent will be obtained at the beginning of the 
appointment if the patient has decided to participate in the study.  The interval between the 
consultation and clinical procedure appointments is usually 1-4 weeks and this interval will 
allow the patient to decide if they would like to participate in the study.  If the patient has 
decided not to participate, the normal clinical procedure for TMJ arthrocentesis will be 
pursued.  Re-evaluation of the subject in the study will occur at 2, 6 and 12 weeks and will 
consist of filling out a questionnaire and a brief physical exam.  The questionnaire and 
physical exam will be administered by the Principal Investigator while the co-PI and sub-
Investigator will perform the TMJ arthrocentesis procedure and the supplementation of the 
placebo or steroid. 
 
 

 
Inclusion criteria: 
 
Female 
 
18 – 80 years of age 
 
TMJ Arthralgia 
 
TMJ Myalgia 
 
TMJ sounds 
 
History of at least 6 weeks use of 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 in TMJ 
 
History of trauma to TMJ 
 
TMJ pain greater than 3 years 
 
History of narcotic drug use on a scheduled basis 
 
Current active infection 
 
 
 
Procedures 
 
 
Patients will be evaluated at the consultation appointment (1st appointment) to determine 
contraindications to the sedation/TMJ arthrocentesis procedure and to evaluate the 
potential benefit of the TMJ lavage procedure.  These procedures are no different than 
those that would be conducted on patients referred for this procedure (see Fig. 1 for 
comparison of normal clinical procedures to the procedures that are proposed in this 
study).  At this first appointment, patients that qualify for the study will be asked to 
participate and will be informed of the study’s procedures and risks.  Patients will not be 
asked to sign the informed consent until the beginning of the second appointment.  If the 
patients decide to participate, they will again review the study procedures and risks and 
then sign the informed consent.  The patient will then be randomized to one of two 
treatment groups: (1) TMJ arthrocentesis with lavage solution (placebo) supplementation 
in the upper joint space; or (2) TMJ arthrocentesis with steroid supplementation (20 mg 
triamcinolone acetonide) in the upper joint space.  The clinical procedure in this study is 
exactly the same as the normal clinical procedure for TMJ arthrocentesis.  The patient will 
be evaluated for a potential pregnancy and a pregnancy test will be administered and a 
negative response will be confirmed if there is any ambiguity in the patient’s history.  The 
patient will be sedated using fentanyl and midazolam, prepped, draped and a local 
anesthetic (3% mepivacaine) will be used to anesthesize the temporomandibular joint 
region.  Two needles will be placed in the upper joint space and the joint will be lavaged 
with 100 cc of Ringers Lactate solution.  Depending on the group that the patient is 
randomly assigned, either additional Ringers Lactate solution (placebo) or triamcinolone 
acetonide (steroid) will be infused into the upper joint space.  The needles will then be 
removed and a bandage will be placed over the needle sites.  The patient will be seen for 
standard questionnaire and physical exam evaluations at 2, 6 and 12 weeks post-
arthrocentesis. 

 
 
Data will be collected on questionnaires and clinical examination forms.  These data will 
be transferred to a custom database for warehousing.  Each subject will be evaluated for 
pain using a VAS measure for spontaneous pain and functional jaw pain (jaw opening and 
closing; TMJ loading) as the primary outcome measures.  Secondary outcome measures 
include the following criteria: opening pattern, maximum unassisted vertical opening with 
pain, maximum unassisted vertical opening with pain, maximum assisted vertical opening, 
masticatory muscle palpation results, intraoral muscle pain results, TMJ palpation and 
TMJ sounds. 
 
 
Power Sample Size Estimation 
 
 
Power sample size estimations were based on the Visual Analog Scale (VAS) 
measures of pain in the two groups after TMJ arthrocentesis (steroid vs no steroid) with a 
difference of 10 (i.e., on a 100 mm scale, a change from 30 to 20) with a standard 
deviation of 8 and an alpha of 0.05.  A power of 0.80 would require a sample size of 12 
subjects per group while a power of 0.90 would require a sample size of 15 subjects (two 
way ANOVA, one between, one within, 2 groups).  Therefore, a total sample size of 30 
subjects should provide sufficient power to test for differences in pain levels between the 
two groups.  We have included a potential drop-out rate of 20% (6 subjects) and have 
added these subjects for the total number of subjects to be recruited at 36 subjects. 
 
 
 
 
Normal Clinical Patient 
 
 
 
 
 
 
 
 
Patient Participating in Study 
 
 
 
 
 
 
 
 
 
 
 
Figure 1.  Procedure Flow-Chart 
 
Pre-Treatment 
Assessment by 
Oral Surgeon 
 
Questionnaire 
and Physical 
Exam 
TMJ 
Arthrocentesis 
procedure 
2 week follow-
up after TMJ 
Arthrocentesis 
procedure 
 
Physical Exam 
6 week follow-
up after TMJ 
Arthrocentesis 
procedure 
 
Physical Exam 
12 week follow-
up after TMJ 
Arthrocentesis 
procedure 
 
Physical Exam 
Pre-Treatment 
Assessment by 
Oral Surgeon 
 
Questionnaire 
and Physical 
Exam 
Obtain 
Informed 
Consent. 
 
Randomized to 
Treatment 
Group 
 
TMJ 
Arthrocentesis 
procedure 
2 week follow-
up after TMJ 
Arthrocentesis 
procedure  
 
Questionnaire 
and Physical 
Exam 
6 weeks follow-
up after TMJ 
Arthrocentesis 
procedure  
 
Questionnaire 
and Physical 
Exam 
12 weeks 
follow-up after 
TMJ 
Arthrocentesis 
procedure 
 
Questionnaire 
and Physical 
Exam 

 
Statistical Analyses 
 
 
Statistical analyses will be conducted by the Principal Investigator and will consist of 
descriptive statistics (mean, standard deviation for parametric data; median and range for 
non-parametric data) and inferential statistics (two way ANOVA, 1 between (groups), 1 
within (time)) using a probability level of < 0.05).  Primary outcome variables are three pain 
variables (resting pain, 2 functional pain assays).  Secondary outcome variables include 
palpable muscle tenderness, range of motion (no-pain limit and maximal opening with 
pain) and joint sounds (type, timing). 
 
 
Adverse Reactions 
 
 
Adverse reactions will be monitored for each patient at the time of clinical care (TMJ 
arthrocentesis) and for each re-evaluation appointment.  Any significant adverse reaction 
will be addressed and treated at the time of the patient report.  These findings will be 
noted in the database and reviewed monthly.  No Data Safety Monitoring Board or 
oversight committee will be formed.  Instead, the three investigators (PI, co-PI and sub-
Investigator) will meet monthly to discuss any adverse reactions that were reported by 
subjects.  The potential occurrence of adverse reactions is expected to be minimal based 
on the outcomes of the patients that have pursued these procedures in the past. 
 
 
Data Confidentiality 
 
Privacy information will only be accessible to the three participants (PI, co-PI and sub-
Investigator).  These data will be transferred from the data collection forms to a PDF 
format and will be stored on a computer that is secured by password protection and 
encryption (with password protection) of the files.  The data collection forms will be 
destroyed using the existing procedure for hardcopy destruction used in the Oral and 
Maxillofacial Surgery Clinic. 
 
 
7. 
Potential Discomforts and Risks: 
 
 
There is no known health risks associated with completion of the questionnaires or the 
brief physical examination.  The physical examination techniques used by the Principal 
Investigator during his evaluation are essentially the same as the techniques used in the 
standard physical exam protocol.  The risk from sedation and steroid supplementation is 
evaluated clinically and patients are excluded based on their medical history.  Pregnant 
females are excluded from participating in this study. 
 
The cost of the TMJ arthrocentesis procedure with steroid/placebo supplementation is 
the responsibility of the study participants (or their insurer) and is considered standard 
therapy for the TMJ pain condition. 
 
There is no anticipated discomfort associated with the steroid supplement.  
Breakthrough pain after the TMJ arthrocentesis procedure will be treated by the standard 
of care for this procedure. 
 
 

8. 
Possible Benefits: 
 
 
There are no known direct health benefits to the subject by this research.  It is currently 
unclear if the addition of a steroid supplement will have a positive impact on the TMJ pain 
and jaw mobility over the TMJ arthrocentesis procedure.  The information obtained from 
this study may help improve the treatment of patients with jaw joint problems in the 
future or may support the elimination of steroid supplementation and, thus, the risk 
(albeit low) of this added medication.  The benefits include the potential for successful 
treatment of temporomandibular joint disorders with the risks being essentially the same 
as that of any proposed standard clinical care. 
 
 
9. 
Conflict of Interest: 
 
 
There is no conflict of interest of any investigators in this research study.