Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

Pain Clinical Trial

Official title:

A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770912
• Other study ID #: IRB201600060
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: January 24, 2019

Study information

• Verified date: September 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 24, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lactated Ringers
Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
• Triamcinolone hexacetonide
1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.

Locations

Country	Name	City	State
United States	University of Florida College of Dentistry	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and 12 weeks post-treatment
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).	Baseline and 2 weeks post-treatment
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).	Baseline and 6 weeks post-treatment
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.	Baseline and 2 weeks post-treatment
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.	Baseline and 6 weeks post-treatment
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.	Baseline and 12 weeks post-treatment
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.	Baseline and 2 weeks post-treatment
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.	Baseline and 6 weeks post-treatment
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.	Baseline and 12 weeks post-treatment
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.	Baseline and 2 weeks post-treatment
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.	Baseline and 6 weeks post-treatment
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.	Baseline and 12 weeks post-treatment
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".	Baseline and 2 weeks post-treatment
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".	Baseline and 6 weeks post-treatment
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".	Baseline and 12 weeks post-treatment