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Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812604
First Posted: December 22, 2008
Last Update Posted: June 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wong Wing Kit, Ricky, The University of Hong Kong
  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
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.

Resource links provided by NLM:


Further study details as provided by Wong Wing Kit, Ricky, The University of Hong Kong:

Primary Outcome Measures:
  • The Efficacy in the Treatment of TMJ and Muscle Pain [ Time Frame: 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:
  • The Mandibular Function. [ Time Frame: 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.


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 Name: TCM topical analgesic
Placebo Comparator: Vaseline
Vaseline with minor trace of Ping On ointment to give medicinal smell
Drug: Vaseline
Placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 19, 2008
First Posted: December 22, 2008
Results First Submitted: June 26, 2012
Results First Posted: June 23, 2014
Last Update Posted: June 23, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Myalgia
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Petrolatum
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Emollients
Dermatologic Agents