Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
Condition: Pain
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Lactated Ringers; Triamcinolone hexacetonide
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Aristospan; steroid
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: facial pain; temporomandibular joint; arthrocentesis; steroid