Temporomandibular Degenerative Joint Disease Clinical Trial
Official title:
Double-blind Randomized Clinical Study on Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease in Women.
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.
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.
;