Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

The University of Hong Kong (HKU)

Status: Completed

Conditions: Temporomandibular Disorders

Treatments: Drug: Vaseline; Drug: Ping On Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT00812604

HKCTR-466

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups, including a placebo group

Ping On Ointment

Experimental group

Description:

Ping On Ointment

Treatment:

Drug: Ping On Ointment

Vaseline

Placebo Comparator group

Description:

Vaseline with minor trace of Ping On ointment to give medicinal smell

Treatment:

Drug: Vaseline