CompletedNCT00812604Updated Jun 23, 2014Results posted

Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

An interventional study of Ping On Ointment and Vaseline in Temporomandibular Disorders, sponsored by The University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-23.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 55
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Temporomandibular Disorders

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In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 55 is above the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 55 participants (actual)

Study arms

Experimental
Ping On Ointment
Ping On Ointment
Drug: Ping On Ointment
Placebo comparator
Vaseline
Vaseline with minor trace of Ping On ointment to give medicinal smell
Drug: Vaseline

Interventions

DrugPing On Ointment
Ping On Ointment
Also known as: TCM topical analgesic
DrugVaseline
Placebo

What researchers measure

Primary outcomes

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).
Time frame: 4 weeks

Secondary outcomes

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.
Time frame: 4 weeks

Results

Posted Jun 23, 2014

Limitations and caveats

In this study, the subjects were screened by clinical examinations and self-reported questionnaires. Ideally, the diagnosis should be made with a combination of radiographs, Magnetic Resonance Imaging or Computer Tomography.

Participant flow

Participant flow — Overall Study
Milestone	Ping On Ointment Group	Placebo Group
Started	28	27
Completed	23	22
Not completed	5	5

Outcome measures

PrimaryThe 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).

Time frame:: 4 weeks
Reported as:: Mean · units on a scale

The Efficacy in the Treatment of TMJ and Muscle Pain
units on a scale	Ping On Ointment Group	Placebo Group
The Efficacy in the Treatment of TMJ and Muscle Pain	21.93 ± 18.07	40.81 ± 14.44

SecondaryThe 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.

Time frame:: 4 weeks
Reported as:: Mean · mm

The Mandibular Function.
mm	Ping On Ointment Group	Placebo Group
The Mandibular Function.	4.435 ± 6.680	0.818 ± 3.404

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ping On Ointment Group	—	0/23 (0%)	0/23 (0%)
Placebo Group	—	0/22 (0%)	0/22 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Ping On Ointment Group	Placebo Group	Total
<=18 years	0	0	0
Between 18 and 65 years	28	27	55
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Ping On Ointment Group	Placebo Group	Total
Mean	47.14 ± 9.296	43.96 ± 13.127	45.51 ± 11.401

Sex: Female, Male
Sex: Female, Male(Participants)	Ping On Ointment Group	Placebo Group	Total
Female	19	16	35
Male	9	11	20

Region of Enrollment
Region of Enrollment(participants)	Ping On Ointment Group	Placebo Group	Total
Hong Kong	28	27	55

Study locations

1 site

Faculty of Dentistry, The University of Hong Kong
Hong Kong, Hong Kong, China

References and documents

Publications

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. PubMed 20001836 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00812604
Lead sponsor: The University of Hong Kong
Responsible party: Wong Wing Kit, Ricky (Associate Professor, Orthodontics, Faculty of Dentistry, The University of Hong Kong) — Principal investigator
First posted: Dec 22, 2008
Start date: Apr 2007
Primary completion: Jun 2008
Completion: Sep 2008
Results posted: Jun 23, 2014
Last update: Jun 23, 2014

Study contacts

Ricky W. K. Wong, PhD

principal investigator · Orthodontics, Faculty of Dentistry, University of Hong Kong

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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