Temporomandibular Degenerative Joint DiseaseNCT00471393
Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease
A study testing 1.5% diclofenac in 45.5% DMSO (topical treatment) in people with Temporomandibular Degenerative Joint Disease, run by University of Alberta at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Degenerative Joint Disease
- What is being tested?
- 1.5% diclofenac in 45.5% DMSO (topical treatment)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- 1.5% diclofenac in 45.5% DMSO (topical treatment), 45.5% DMSO (topical placebo)
- Keywords
- TMJ, Osteoarthritis, Degenerative Joint disease
- Medical subject headings
- Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.5% diclofenac in 45.5% DMSO (topical treatment)Drug
45.5% DMSO (topical placebo)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 90 days
5.To compare the adverse effects documented by the topical diclofenac group to those documented by the topical placebo group.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startMay 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Degenerative Joint DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Norman Thie, BSc DDS MSc, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471393
- Sponsor's protocol ID
- FMW 5936
- Other IDs
- File #103090 Health Canada, Grant#2005-04
- Status last verified
- Nov 2024
- First submitted
- 7 May 2007
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1186/1471-2474-5-28.
PubMed 15317652Mason 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. doi: 10.1186/1471-2296-5-10.
PubMed 15147585Moore RA, Tramer 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. doi: 10.1136/bmj.316.7128.333.
PubMed 9487165Roth 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. doi: 10.1001/archinte.164.18.2017.
PubMed 15477437Tugwell 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.
PubMed 15468367Towheed 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.
PubMed 16511925
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Clinical Study on Topical Diclofenac Efficacy in Symptomatic Relief of Temporomandibular Degenerative Joint Disease in Women.
- ClinicalTrials.gov ID
- NCT00471393
- Acronym / sponsor ID
- FMW 5936
- Keywords
- TMJ, Osteoarthritis, Degenerative Joint disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 9 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.5% diclofenac in 45.5% DMSO (topical treatment) | Drug | – |
| 45.5% DMSO (topical placebo) | Drug | – |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 15317652Mason 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. doi: 10.1186/1471-2474-5-28.
- Background: PubMed 15147585Mason 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. doi: 10.1186/1471-2296-5-10.
- Background: PubMed 9487165Moore RA, Tramer 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. doi: 10.1136/bmj.316.7128.333.
- Background: PubMed 15477437Roth 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. doi: 10.1001/archinte.164.18.2017.
- Background: PubMed 15468367Tugwell 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.
- Background: PubMed 16511925Towheed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Thie, BSc DDS MSc study director
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.5% diclofenac in 45.5% DMSO (topical treatment) in people with Temporomandibular Degenerative Joint Disease, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00471393, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.