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.
| Verified date | May 2007 |
| Source | University of Alberta, Graduate Orthodontic Program |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | April 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - A baseline score of = 3.0 cm on a 10 cm measured VAS (Visual Analogue Scale) according to the criteria established by Collins et al. (Collins, Moore, & Mcquay, 1997) (for moderate and severe pain) required for participants prior to use of analgesics, in order to provide adequate sensitivity. - Females from the ages of 18 to 45 years of age inclusive. - Primary degenerative joint disease as diagnosed through radiographs utilizing volumetric cone beam computed tomographic images reformatted in axial, coronal, and sagittal views that will be assessed by an independent radiologist. Exclusion Criteria: - Nursing or expectant females or females planning on becoming pregnant. - Participants not clearly diagnosed as having symptomatic degenerative joint disease. - Participants having DJD secondarily to trauma, previous infection or general joint/muscle disease. - Participants who have experienced adverse reactions to any of the components of the formulation used in the study. - Participants who have evidence of periodontal disease, dental caries, oral pathology or infections of the oral cavity. - Participants with a history of neuropathic pain in the orofacial region. - Participants scheduled for surgery in the near future. - Participants currently undergoing orthodontic treatment. - Participants with a history of epilepsy, cardiovascular disease, renal disease/disorder, hepatic disease/disorder, glaucoma, bowel obstruction, urinary retention, diabetes, hypertension or orthostatic hypotension. - Participants with a malignancy. - Participants who are currently using topical preparations for palliative relief for their DJD. - Participants with a baseline intensity of = 3/10 on the VAS. - Inability to understand English. - Participants who have been wearing an occlusal splint = 3 months. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Alberta | Edmonton | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alberta, Graduate Orthodontic Program | University of Alberta |
Canada,
Mason L, Moore RA, Edwards JE, Derry S, McQuay HJ. Topical NSAIDs for acute pain: a meta-analysis. BMC Fam Pract. 2004 May 17;5:10. — View Citation
Mason L, Moore RA, Edwards JE, Derry S, McQuay HJ. Topical NSAIDs for chronic musculoskeletal pain: systematic review and meta-analysis. BMC Musculoskelet Disord. 2004 Aug 19;5:28. Review. — View Citation
Moore RA, Tramèr MR, Carroll D, Wiffen PJ, McQuay HJ. Quantitative systematic review of topically applied non-steroidal anti-inflammatory drugs. BMJ. 1998 Jan 31;316(7128):333-8. Erratum in: BMJ 1998 Apr 4;316(7137):1059. — View Citation
Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (pennsaid) in the treatment of primary osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled clinical trial. Arch Intern Med. 2004 Oct 11;164(18):2017-23. — View Citation
Towheed TE. Pennsaid therapy for osteoarthritis of the knee: a systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2006 Mar;33(3):567-73. Review. — View Citation
Tugwell PS, Wells GA, Shainhouse JZ. Equivalence study of a topical diclofenac solution (pennsaid) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol. 2004 Oct;31(10):2002-12. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 1.To compare the efficacy of topical placebo and topical diclofenac in functional pain intensity at commencement of the study, Day 30, Day 60 and Day 90 through the use of VAS. | 90 days | ||
| Secondary | 1.To compare the efficacy of topical placebo and topical diclofenac in voluntary and assisted vertical jaw opening through the use of a 100 mm ruler from commencement of the study, Day 30, Day 60 and Day 90. | 90 days | ||
| Secondary | 2.To compare the efficacy of topical placebo and topical diclofenac on the effect on quality of life by comparing measures at the commencement of the study to the end of treatment, through use of a subsection of The Brief Pain Inventory Scale (BPI). | 90 days | ||
| Secondary | 3.To compare the efficacy of topical placebo and topical diclofenac on pain intensity by comparing measures obtained at the commencement of the study, to those obtained at the end using a subsection of The Brief Pain Inventory Scale. | 90 days | ||
| Secondary | 4.To compare the efficacy of topical placebo and topical diclofenac on the disability on specific activities of daily living by comparing baseline measures, to that obtained at the end of treatment, utilizing The Pain Disability Index. | 90 days | ||
| Secondary | 5.To compare the adverse effects documented by the topical diclofenac group to those documented by the topical placebo group. | 90 days | ||
| Secondary | 6.To compare the amount of breakthrough medication used by the topical diclofenac group versus the topical placebo group in order to assess if the use of topical diclofenac reduces the amount of oral medication. | 90 days |