Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease

This study has been completed.
Sponsor:
Collaborator:
University of Alberta
Information provided by:
University of Alberta, Graduate Orthodontic Program
ClinicalTrials.gov Identifier:
NCT00471393
First received: May 7, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Temporomandibular Degenerative Joint Disease.
Drug: 1.5% diclofenac in 45.5% DMSO (topical treatment)
Drug: 45.5% DMSO (topical placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind Randomized Clinical Study on Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease in Women.

Resource links provided by NLM:


Further study details as provided by University of Alberta, Graduate Orthodontic Program:

Primary Outcome Measures:
  • 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. [ Time Frame: 90 days ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 90 days ]
  • 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). [ Time Frame: 90 days ]
  • 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. [ Time Frame: 90 days ]
  • 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. [ Time Frame: 90 days ]
  • 5.To compare the adverse effects documented by the topical diclofenac group to those documented by the topical placebo group. [ Time Frame: 90 days ]
  • 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. [ Time Frame: 90 days ]

Enrollment: 28
Study Start Date: May 2006
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471393

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2N8
Sponsors and Collaborators
University of Alberta, Graduate Orthodontic Program
University of Alberta
Investigators
Study Director: Norman Thie, BSc DDS MSc University of Alberta
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00471393     History of Changes
Obsolete Identifiers: NCT00699647
Other Study ID Numbers: FMW 5936, File #103090 Health Canada, Grant#2005-04
Study First Received: May 7, 2007
Last Updated: May 7, 2007
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta, Graduate Orthodontic Program:
TMJ
Osteoarthritis
Degenerative Joint disease

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Diclofenac
Dimethyl Sulfoxide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cryoprotective Agents
Protective Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on August 26, 2014