Back to resultsAnalgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain
Primary Purpose
Temporomandibular Disorders
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ping On Ointment
Vaseline
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorders
Eligibility Criteria
Inclusion Criteria:
- Self report of facial ache or pain in the muscles of mastication, the TMJ, or the region in front of ear or inside the ear
- Positive clinical diagnosis of TMDs. The TMD diagnosis is classified using axis I of the research diagnostic criteria ( RDC) for TMDs. The RDC diagnosis consists of joint pain at rest ( spontaneous pain) and evoked pain (hyperalgesia) on palpation of the TMJ, TMJ reduction consists of reciprocal clicking or joint noise with mandibular movement examination.
- For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.
- Subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with TMDs are known to exhibit muscle pain secondary to their joint dysfunction.
Exclusion Criteria:
- Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
- Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
- Subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months;
- Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
- Subjects who are not competent in giving consents.
- Pregnant or lactating women
- Subjects with sensitivity to the ingredient of Ping On Ointment will be excluded.
Sites / Locations
- Faculty of Dentistry, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ping On Ointment
Vaseline
Arm Description
Ping On Ointment
Vaseline with minor trace of Ping On ointment to give medicinal smell
Outcomes
Primary Outcome Measures
The Efficacy in the Treatment of TMJ and Muscle Pain
The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).
The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as "no pain" ( 0 mm) and " worst pain possible" ( 100 mm).
Secondary Outcome Measures
The Mandibular Function.
The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.
Full Information
NCT ID
NCT00812604
First Posted
December 19, 2008
Last Updated
May 21, 2014
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00812604
Brief Title
Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain
Official Title
Effect of an Analgesic Ointment on the Relief of Temporomandibular Joint and Masticatory Muscle Pain: a Randomized, Double Blinded, Placebo-controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered intervention.
Detailed Description
Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group 1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ping On Ointment
Arm Type
Experimental
Arm Description
Ping On Ointment
Arm Title
Vaseline
Arm Type
Placebo Comparator
Arm Description
Vaseline with minor trace of Ping On ointment to give medicinal smell
Intervention Type
Drug
Intervention Name(s)
Ping On Ointment
Other Intervention Name(s)
TCM topical analgesic
Intervention Description
Ping On Ointment
Intervention Type
Drug
Intervention Name(s)
Vaseline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The Efficacy in the Treatment of TMJ and Muscle Pain
Description
The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).
The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as "no pain" ( 0 mm) and " worst pain possible" ( 100 mm).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The Mandibular Function.
Description
The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self report of facial ache or pain in the muscles of mastication, the TMJ, or the region in front of ear or inside the ear
Positive clinical diagnosis of TMDs. The TMD diagnosis is classified using axis I of the research diagnostic criteria ( RDC) for TMDs. The RDC diagnosis consists of joint pain at rest ( spontaneous pain) and evoked pain (hyperalgesia) on palpation of the TMJ, TMJ reduction consists of reciprocal clicking or joint noise with mandibular movement examination.
For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.
Subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with TMDs are known to exhibit muscle pain secondary to their joint dysfunction.
Exclusion Criteria:
Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
Subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months;
Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
Subjects who are not competent in giving consents.
Pregnant or lactating women
Subjects with sensitivity to the ingredient of Ping On Ointment will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricky W. K. Wong, PhD
Organizational Affiliation
Orthodontics, Faculty of Dentistry, University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, The University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
20001836
Citation
Li LC, Wong RW, Rabie AB. Clinical effect of a topical herbal ointment on pain in temporomandibular disorders: a randomized placebo-controlled trial. J Altern Complement Med. 2009 Dec;15(12):1311-7. doi: 10.1089/acm.2009.0129.
Results Reference
derived
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Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain
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