N/A
N=55
Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain
Temporomandibular Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00812604 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: The Efficacy in the Treatment of TMJ and Muscle Pain — 21.93; 40.81 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ping On Ointment (Drug); Vaseline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Hong Kong
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Efficacy in the Treatment of TMJ and Muscle Pain |
21.93; 40.81 | — |
| SECONDARY The Mandibular Function. |
4.435; 0.818 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00812604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.