Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease
Condition: Temporomandibular Degenerative Joint Disease
MeSH terms: Joint Diseases; Osteoarthritis
Study type: Interventional

Summary: 
      The use of a topical medication was compared to placebo to be applied over the symptomatic
      temporomandibular joint in women with the diagnosis of osteoarthritis of the
      temporomandibular joint(s).

      The hypothesis is to investigate whether the use of a topical anti-inflammatory medication
      when compared to the placebo would decrease the pain of the affected joint and/or increased
      mouth opening.
    

Detailed description: 
      The purpose of this study is to measure the efficacy of topical diclofenac to topical placebo
      in the symptomatic relief of degenerative temporomandibular joint disease in a female
      population between the ages of 18-45 years of age.

      Primary Objectives:

        -  To compare the efficacy of placebo and diclofenac topical PLO gel in terms of functional
           pain intensity of symptomatic temporomandibular degenerative joint disease in
           participants by comparing baseline measures obtained prior to commencement of the study,
           with the measurements obtained at 30, 60 and 90 days during the treatment intervention
           through the use of a Visual Analogue Scale (VAS).

      Secondary Objectives:

        -  To compare the efficacy of placebo and diclofenac topical in PLO gel in terms of
           measurement of the range of motion of voluntary and assisted vertical jaw opening of
           symptomatic temporomandibular degenerative joint disease (TMDJD) in participants by
           comparing baseline measures obtained prior to commencement of the study, Time 0, through
           the use of a 100 mm ruler to measures obtained at 30, 60 and 90 days during the
           treatment intervention.

        -  To compare the efficacy of placebo and diclofenac in terms of effect on quality of life
           of symptomatic TMDJD in participants by comparing baseline measures obtained prior to
           commencement of the study, Time 0, to measures obtained after 90 consecutive days of
           treatment, utilizing a subsection of The Brief Pain Inventory Scale (BPI) which relates
           to quality of life.

        -  To compare the efficacy of placebo and diclofenac in terms of effect on pain intensity
           of symptomatic TMDJD in participants by comparing baseline measures obtained prior to
           commencement of the study, Time 0, to measures obtained after 90 consecutive days of
           treatment, utilizing a subsection of The Brief Pain Inventory Scale (BPI) (Cleeland &
           Ryan, 1994) which relates to pain intensity.

        -  To compare the efficacy of placebo and diclofenac topical PLO gel in terms of effect on
           disability on specific activities of daily living of TMDJD participants by comparing
           baseline measures obtained prior to the commencement of the study, Time 0, to that
           obtained after 90 consecutive day of treatment, utilizing The Pain Disability Index
           (PDI) (Bush & Harkin, 1995).

      Tertiary Objectives

        -  To compare the adverse effects documented by the topical diclofenac group to those
           documented by the topical placebo group.

        -  To compare the amount of breakthrough medication used by the topical diclofenac group
           versus the placebo group in order to assess if the use of topical diclofenac reduces the
           amount of oral medication.

        -  To compare reasons for withdrawal from the study between topical placebo and topical
           diclofenac groups.

      The null hypothesis is that there is no difference between the efficacy of topical diclofenac
      and topical placebo in the treatment of degenerative temporomandibular joint disease.
    

Intervention name(s): 1.5% diclofenac in 45.5% DMSO (topical treatment); 45.5% DMSO (topical placebo)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Diclofenac; Dimethyl Sulfoxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: TMJ; Osteoarthritis; Degenerative Joint disease