Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

Effect of an Analgesic Ointment on the Relief of Temporomandibular Joint and Masticatory Muscle Pain: a Randomized, Double Blinded, Placebo-controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorders
• Intervention / Treatment: Drug: Ping On Ointment; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (Estimate): December 22, 2008

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Myalgia; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Emollients; Analgesics; Petrolatum
• Other Study ID Numbers: HKCTR-466