Temporomandibular Disorders
Conditions
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.
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.
Interventions
DRUGPing On Ointment
Ping On Ointment
DRUGVaseline
Placebo
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ping On Ointment Group Ping On Ointment was used | 28 |
| Placebo Group Vaseline with minor trace of Ping On Ointment was used | 27 |
| Total | 55 |
Baseline characteristics
| Characteristic | Placebo Group | Ping On Ointment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 28 Participants | 55 Participants |
| Age, Continuous | 43.96 years STANDARD_DEVIATION 13.127 | 47.14 years STANDARD_DEVIATION 9.296 | 45.51 years STANDARD_DEVIATION 11.401 |
| Region of Enrollment Hong Kong | 27 participants | 28 participants | 55 participants |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
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).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ping On Ointment Group | The Efficacy in the Treatment of TMJ and Muscle Pain | 21.93 units on a scale | Standard Deviation 18.07 |
| Placebo Group | The Efficacy in the Treatment of TMJ and Muscle Pain | 40.81 units on a scale | Standard Deviation 14.44 |
Secondary
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ping On Ointment Group | The Mandibular Function. | 4.435 mm | Standard Deviation 6.68 |
| Placebo Group | The Mandibular Function. | 0.818 mm | Standard Deviation 3.404 |