Temporomandibular DisordersNCT00812604

Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

A study testing Ping On Ointment and Vaseline in people with Temporomandibular Disorders, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Temporomandibular Disorders
What is being tested?: Ping On Ointment and Vaseline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 siteChina
Study dates: Apr 2007to Sep 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
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.
For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.
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.

Who cannot join

Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
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;
Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
Subjects who are not competent in giving consents.
Pregnant or lactating women
Subjects with sensitivity to the ingredient of Ping On Ointment will be excluded.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

Read the 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.

Conditions: Temporomandibular Disorders
Being tested: Ping On Ointment, Vaseline
Medical subject headings: Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ping On OintmentDrug
Also called TCM topical analgesic
Ping On Ointment
VaselineDrug
Placebo

Study groups in NCT00812604
Study group	Role	What they receive
Ping On Ointment	Experimental	Ping On Ointment Receives: Drug: Ping On Ointment
Vaseline	Placebo comparator	Vaseline with minor trace of Ping On ointment to give medicinal smell Receives: Drug: Vaseline

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 4 weeks

Secondary outcomes (1)

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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Sep 2008

First posted22 Dec 2008 (estimated)
Study startApr 2007
Primary completionJun 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00812604
Sponsor's protocol ID: HKCTR-466
Status last verified: May 2014
First submitted: 19 Dec 2008
Last updated: 23 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 20001836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Temporomandibular Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of an Analgesic Ointment on the Relief of Temporomandibular Joint and Masticatory Muscle Pain: a Randomized, Double Blinded, Placebo-controlled Study.
ClinicalTrials.gov ID: NCT00812604
Acronym / sponsor ID: HKCTR-466
Conditions: Temporomandibular Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: Apr 2007
Primary completion: Jun 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 22 Dec 2008 (estimated)
Results: Posted 23 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ping On Ointment	Experimental	Drug: Ping On OintmentPing On Ointment
Vaseline	Placebo comparator	Drug: VaselineVaseline with minor trace of Ping On ointment to give medicinal smell

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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
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.
For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.
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.

Key exclusion criteria (7 listed)

Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
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;
Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
Subjects who are not competent in giving consents.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ping On OintmentAlso: TCM topical analgesicPing On Ointment	Drug	Ping On Ointment
VaselinePlacebo	Drug	Vaseline

Primary outcome

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).

1 secondary outcome

The Mandibular Function.
Time frame: 4 weeks

Results and safety

Results posted to the registry on 23 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ping On Ointment Group	28	23
Placebo Group	27	22

Primary outcome: The Efficacy in the Treatment of TMJ and Muscle Pain

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Ping On Ointment Group n = 23	Placebo Group n = 22
Value	21.93 (18.07)	40.81 (14.44)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ping On Ointment Group	0 of 23 (0%)	0 of 23 (0%)	Not reported
Placebo Group	0 of 22 (0%)	0 of 22 (0%)	Not reported

Limitations and caveats (from the sponsor): In this study, the subjects were screened by clinical examinations and self-reported questionnaires. Ideally, the diagnosis should be made with a combination of radiographs, Magnetic Resonance Imaging or Computer Tomography.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20001836Li 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.

Related trials for Temporomandibular Disorders

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ricky W. K. Wong, PhD principal investigator

Orthodontics, Faculty of Dentistry, University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ping On Ointment and Vaseline in people with Temporomandibular Disorders, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Efficacy in the Treatment of TMJ and Muscle Pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812604, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.