Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain
This study has been completed.
Information provided by (Responsible Party):
Wong Wing Kit, Ricky, The University of Hong Kong
First received: December 19, 2008
Last updated: May 21, 2014
Last verified: May 2014
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.
Drug: Ping On Ointment
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Effect of an Analgesic Ointment on the Relief of Temporomandibular Joint and Masticatory Muscle Pain: a Randomized, Double Blinded, Placebo-controlled Study.
Primary Outcome Measures:
- The Efficacy in the Treatment of TMJ and Muscle Pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2008 (Final data collection date for primary outcome measure)
Experimental: Ping On Ointment
Ping On Ointment
Drug: Ping On Ointment
Ping On Ointment
Other Name: TCM topical analgesic
Placebo Comparator: Vaseline
Vaseline with minor trace of Ping On ointment to give medicinal smell
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00812604
|Faculty of Dentistry, The University of Hong Kong
|Hong Kong, Hong Kong, China |
The University of Hong Kong
||Ricky W. K. Wong, PhD
||Orthodontics, Faculty of Dentistry, University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Wong Wing Kit, Ricky, Associate Professor, Orthodontics, Faculty of Dentistry, The University of Hong Kong
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 19, 2008
|Results First Received:
||June 26, 2012
||May 21, 2014
||Hong Kong: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 26, 2016
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Myofascial Pain Syndromes
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents