Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

NCT00812604 | Completed Results

• 1 other identifier: HKCTR-466
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders

Outcome Measures

Primary Outcomes (1)

• 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).

  4 weeks

Secondary Outcomes (1)

• The Mandibular Function.

  4 weeks

Study Arms (2)

Ping On Ointment

EXPERIMENTAL

Ping On Ointment

Drug: Ping On Ointment

Vaseline

PLACEBO COMPARATOR

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

Drug: Vaseline

Interventions

Ping On Ointment DRUG

Ping On Ointment

Also known as: TCM topical analgesic

Ping On Ointment

Vaseline DRUG

Placebo

Vaseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Faculty of Dentistry, The University of Hong Kong

Hong Kong, Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 20001836 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

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.

Results Point of Contact

• Title: Dr. Ricky Wing Kit Wong, Associate professor in orthodontics
• Organization: University of Hong Kong

fyoung@hkucc.hku.hk

852-2859 0554

Study Officials

• Ricky W. K. Wong, PhD

  Orthodontics, Faculty of Dentistry, University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Orthodontics, Faculty of Dentistry

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 22, 2008
• Study Start: April 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 23, 2014
• Results First Posted: June 23, 2014

Record last verified: 2014-05

Locations

CN (1)