Clinical trial NCT00812604: 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
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. 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.
3. For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.
4. 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:

1. Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
2. Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
3. 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;
4. Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
5. Subjects who are not competent in giving consents.
6. Pregnant or lactating women
7. Subjects with sensitivity to the ingredient of Ping On Ointment will be excluded.

Primary outcomes:
measure: The Efficacy in the Treatment of TMJ and Muscle Pain
timeFrame: 4 weeks
Secondary outcomes:
measure: The Mandibular Function.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Faculty of Dentistry, The University of Hong Kong
state: Hong Kong
Study officials:
affiliation: Orthodontics, Faculty of Dentistry, University of Hong Kong
name: Ricky W. K. Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.