Trial Outcomes & Findings for Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain (NCT NCT00812604)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Ping On Ointment Group Ping On Ointment was used	Placebo Group Vaseline with minor trace of Ping On Ointment was used
Overall Study STARTED	28	27
Overall Study COMPLETED	23	22
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ping On Ointment Group n=28 Participants Ping On Ointment was used	Placebo Group n=27 Participants Vaseline with minor trace of Ping On Ointment was used	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=39 Participants	27 Participants n=41 Participants	55 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	47.14 years STANDARD_DEVIATION 9.296 • n=39 Participants	43.96 years STANDARD_DEVIATION 13.127 • n=41 Participants	45.51 years STANDARD_DEVIATION 11.401 • n=35 Participants
Sex: Female, Male Female	19 Participants n=39 Participants	16 Participants n=41 Participants	35 Participants n=35 Participants
Sex: Female, Male Male	9 Participants n=39 Participants	11 Participants n=41 Participants	20 Participants n=35 Participants
Region of Enrollment Hong Kong	28 participants n=39 Participants	27 participants n=41 Participants	55 participants n=35 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ping On Ointment Group n=23 Participants Ping On Ointment was used	Placebo Group n=22 Participants Vaseline with minor trace of Ping On Ointment was used
The Efficacy in the Treatment of TMJ and Muscle Pain	21.93 units on a scale Standard Deviation 18.07	40.81 units on a scale Standard Deviation 14.44

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ping On Ointment Group n=23 Participants Ping On Ointment was used	Placebo Group n=22 Participants Vaseline with minor trace of Ping On Ointment was used
The Mandibular Function.	4.435 mm Standard Deviation 6.680	0.818 mm Standard Deviation 3.404

Adverse Events

Ping On Ointment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ricky Wing Kit Wong, Associate professor in orthodontics

University of Hong Kong

Phone: 852-2859 0554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place