Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wong Wing Kit, Ricky, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00812604
First received: December 19, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention
Temporomandibular Disorders
Drug: Ping On Ointment
Drug: Vaseline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • The Efficacy in the Treatment of TMJ and Muscle Pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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:
  • The Mandibular Function. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.


Enrollment: 55
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ping On Ointment
Ping On Ointment
Drug: Ping On Ointment
Ping On Ointment
Other Names:
  • Ping On Ointment
  • TCM topical analgesic
Placebo Comparator: Vaseline
Vaseline with minor trace of Ping On ointment to give medicinal smell
Drug: Vaseline
Placebo
Other Name: Vaseline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812604

Locations
China, Hong Kong
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
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wong Wing Kit, Ricky, Associate Professor, Orthodontics, Faculty of Dentistry, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00812604     History of Changes
Other Study ID Numbers: HKCTR-466
Study First Received: December 19, 2008
Results First Received: June 26, 2012
Last Updated: May 21, 2014
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Jaw Diseases
Joint Diseases
Mandibular Diseases
Muscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Stomatognathic Diseases
Analgesics
Petrolatum
Central Nervous System Agents
Dermatologic Agents
Emollients
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014