Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00812604
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorders	Drug: Ping On Ointment; Drug: Vaseline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ping On Ointment Ping On Ointment	Drug: Ping On Ointment; Ping On Ointment; Other Names: TCM topical analgesic
Placebo Comparator: Vaseline Vaseline with minor trace of Ping On ointment to give medicinal smell	Drug: Vaseline; Placebo

Outcome Measures

Primary Outcome Measures

1. The Efficacy in the Treatment of TMJ and Muscle Pain [4 weeks]

   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

1. The Mandibular Function. [4 weeks]

   The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, The University of Hong Kong	Hong Kong	Hong Kong	China

Sponsors and Collaborators

• The University of Hong Kong

Investigators

• Principal Investigator: Ricky W. K. Wong, PhD, Orthodontics, Faculty of Dentistry, University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wong Wing Kit, Ricky, Associate Professor, Orthodontics, Faculty of Dentistry, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT00812604
• Other Study ID Numbers: HKCTR-466
• First Posted: Dec 22, 2008
• Last Update Posted: Jun 23, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Myalgia; Analgesics; Petrolatum

Study Results

Participant Flow

Arm/Group Title	Ping On Ointment Group	Placebo Group
Arm/Group Description	Ping On Ointment was used	Vaseline with minor trace of Ping On Ointment was used
Period Title: Overall Study
STARTED	28	27
COMPLETED	23	22
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Ping On Ointment Group	Placebo Group	Total
Arm/Group Description	Ping On Ointment was used	Vaseline with minor trace of Ping On Ointment was used	Total of all reporting groups
Overall Participants	28	27	55
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 100%	27 100%	55 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.14 (9.296)	43.96 (13.127)	45.51 (11.401)
Sex: Female, Male (Count of Participants)
Female	19 67.9%	16 59.3%	35 63.6%
Male	9 32.1%	11 40.7%	20 36.4%
Region of Enrollment (participants) [Number]
Hong Kong	28 100%	27 100%	55 100%

Outcome Measures

1. Primary Outcome

Title	The Efficacy in the Treatment of TMJ and Muscle Pain
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ping On Ointment Group	Placebo Group
Arm/Group Description	Ping On Ointment was used	Vaseline with minor trace of Ping On Ointment was used
Measure Participants	23	22
Mean (Standard Deviation) [units on a scale]	21.93 (18.07)	40.81 (14.44)

2. Secondary Outcome

Title	The Mandibular Function.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ping On Ointment Group	Placebo Group
Arm/Group Description	Ping On Ointment was used	Vaseline with minor trace of Ping On Ointment was used
Measure Participants	23	22
Mean (Standard Deviation) [mm]	4.435 (6.680)	0.818 (3.404)

Adverse Events

Arm/Group Title	Ping On Ointment Group		Placebo Group
Arm/Group Description	Ping On Ointment was used		Vaseline with minor trace of Ping On Ointment was used
All Cause Mortality
	Ping On Ointment Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ping On Ointment Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Ping On Ointment Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.