PainPPTNCT02131714
Pressure Pain Threshold of Jaw Muscles in TMD Patients Submitted to a Conservative Treatment
A study testing counseling and exercises and lifestyle counseling in people with Pain and Myofascial Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Pain is an unpleasant sensory and emotional experience that is one of the main symptoms of temporomandibular disorder (TMD). One way to assess pain is through algometry. The aim of this study was to evaluate, by the pressure pain threshold measurements, the efficacy of a short-term conservative treatment for the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Myofascial Pain, Temporomandibular Disorder Syndrome
- What is being tested?
- counseling and exercises and lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 18 years old have diagnosis of myofascial pain according RDC/TMD signed the informed consent
Who cannot join
- people under 18 years old
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ambulatorio de Disfunção Temporomandibular e Dor Orofacial
São Paulo, São Paulo, 04023-061
About this study
Official title: Pressure Pain Threshold of Jaw Muscles in Patients With Facial Myofascial Pain Submitted to a Conservative Treatment : a Short-term Evaluation
Pain is an unpleasant sensory and emotional experience that is one of the main symptoms of temporomandibular disorder (TMD). One way to assess pain is through algometry. The aim of this study was to evaluate, by the pressure pain threshold measurements, the efficacy of a short-term conservative treatment for the management of temporomandibular disorders. This study is a randomized controlled clinical trial where 84 participants were diagnosed with myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), with a mean age of 44 years old ranging from 18 to 76 years old. These individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. They also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times. The pressure pain threshold of the masseter and temporalis muscles and the lateral pole of the condyle were obtained at baseline (T0), between 15 and 30 days after (T1) and at 75 to 90 days after (T2) representing the end of the treatment. Two groups of subjects were obtained. The first was considered the study group (SG) and included those who underwent the treatment proposed. The control group (CG) consisted of participants who did not undergo treatment because they did not believe in it.
- Conditions
- Pain, Myofascial Pain, Temporomandibular Disorder Syndrome, Therapeutic Exercise, Facial Pain
- Being tested
- counseling and exercises, lifestyle counseling
- Keywords
- pressure pain threshold, temporomandibular disorder syndrome, therapeutic exercise, conservative treatment, facial pain
- Medical subject headings
- Pain, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling and exercisesBehavioural
These individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. They also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times
lifestyle counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| counseling and exercises | Active comparator | These individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. They also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times Receives: Behavioral: counseling and exercises |
| lifestyle counseling | Placebo comparator | These individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. Receives: Behavioral: lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure pain threshold (PPT) in Kilogram-force (Kgf)
-pressure pain threshold (PPT) from masseter and temporalis muscles, and lateral pole of the condyle in both sides of the face.
It was measured with a digital algometer.
Measured: at baseline (first appointment)
pressure pain threshold (PPT) in Kilogram-force (Kgf)
-pressure pain threshold (PPT) from masseter and temporalis muscles, and lateral pole of the condyle in both sides of the face.
It was measured with a digital algometer.
Measured: 3 to 4 weeks (second appointment)
pressure pain threshold (PPT) in Kilogram-force (Kgf)
pressure pain threshold (PPT) from masseter and temporalis muscles, and lateral pole of the condyle in both sides of the face.
It was measured with a digital algometer.
Measured: 10 to 12 weeks (last appointment)
Secondary outcomes (6)
Visual analogue scale (VAS). A line with 100mm where in one extremity its wrote "no pain" and in the end of the line its wrote "the worst pain"
- Visual analogue scale (VAS) for measuring pain.
Measured: at baseline (first appointment)
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
- Verbal numerical scale (VNS) for measuring pain. Ask the patient to quantify his pain in a 11-point pain scale, where 0 is no pain and 10 the worst pain he ever had.
Measured: at baseline (first appointment)
Visual analogue scale (VAS). A line with 100mm where in one extremity its wrote "no pain" and in the end of the line its wrote "the worst pain"
Visual analogue scale (VAS) for measuring pain.
Measured: 3 to 4 weeks (second appointment)
Visual analogue scale (VAS). A line with 100mm where in one extremity its wrote "no pain" and in the end of the line its wrote "the worst pain"
Visual analogue scale (VAS) for measuring pain.
Measured: 10 to 12 weeks (last appointment)
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Verbal numerical scale (VNS) for measuring pain. Ask the patient to quantify his pain in a 11-point pain scale, where 0 is no pain and 10 the worst pain he ever had.
Measured: 3 to 4 weeks (second appointment)
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Verbal numerical scale (VNS) for measuring pain. Ask the patient to quantify his pain in a 11-point pain scale, where 0 is no pain and 10 the worst pain he ever had.
Measured: 10 to 12 weeks (last appointment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Lalue Sanches, Federal University of São Paulo
- Investigators
- Luis G Alonso, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131714
- Sponsor's protocol ID
- TMD-2003
- Acronym
- PPT
- Status last verified
- May 2014
- First submitted
- 21 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Pain Threshold of Jaw Muscles in Patients With Facial Myofascial Pain Submitted to a Conservative Treatment : a Short-term Evaluation
- ClinicalTrials.gov ID
- NCT02131714
- Acronym / sponsor ID
- PPT / TMD-2003
- Conditions
- Pain, Myofascial Pain, Temporomandibular Disorder Syndrome, Therapeutic Exercise, Facial Pain
- Keywords
- pressure pain threshold, temporomandibular disorder syndrome, therapeutic exercise, conservative treatment, facial pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain is an unpleasant sensory and emotional experience that is one of the main symptoms of temporomandibular disorder (TMD). One way to assess pain is through algometry. The aim of this study was to evaluate, by the pressure pain threshold measurements, the efficacy of a short-term conservative treatment for the management of temporomandibular disorders. This study is a randomized controlled clinical trial where 84 participants were diagnosed with myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), with a mean age of 44 years old ranging from 18 to 76 years old. These individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. They also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times. The pressure pain threshold of the masseter and temporalis muscles and the lateral pole of the condyle were obtained at baseline (T0), between 15 and 30 days after (T1) and at 75 to 90 days after (T2) representing the end of the treatment. Two groups of subjects were obtained. The first was considered the study group (SG) and included those who underwent the treatment proposed. The control group (CG) consisted of participants who did not undergo treatment because they did not believe in it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| counseling and exercises | Active comparator | Behavioral: counseling and exercisesThese individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. They also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times |
| lifestyle counseling | Placebo comparator | Behavioral: lifestyle counselingThese individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- more than 18 years old have diagnosis of myofascial pain according RDC/TMD signed the informed consent
Key exclusion criteria (1 listed)
- people under 18 years old
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 |
|---|---|---|
| counseling and exercisesThese individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. They also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times | Behavioural | counseling and exercises |
| lifestyle counseling | Behavioural | lifestyle counseling |
Primary outcome
pressure pain threshold (PPT) in Kilogram-force (Kgf)
Time frame: at baseline (first appointment)
-pressure pain threshold (PPT) from masseter and temporalis muscles, and lateral pole of the condyle in both sides of the face. It was measured with a digital algometer.
pressure pain threshold (PPT) in Kilogram-force (Kgf)
Time frame: 3 to 4 weeks (second appointment)
-pressure pain threshold (PPT) from masseter and temporalis muscles, and lateral pole of the condyle in both sides of the face. It was measured with a digital algometer.
pressure pain threshold (PPT) in Kilogram-force (Kgf)
Time frame: 10 to 12 weeks (last appointment)
pressure pain threshold (PPT) from masseter and temporalis muscles, and lateral pole of the condyle in both sides of the face. It was measured with a digital algometer.
6 secondary outcomes
Visual analogue scale (VAS). A line with 100mm where in one extremity its wrote "no pain" and in the end of the line its wrote "the worst pain"
Time frame: at baseline (first appointment)
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Time frame: at baseline (first appointment)
Visual analogue scale (VAS). A line with 100mm where in one extremity its wrote "no pain" and in the end of the line its wrote "the worst pain"
Time frame: 3 to 4 weeks (second appointment)
Visual analogue scale (VAS). A line with 100mm where in one extremity its wrote "no pain" and in the end of the line its wrote "the worst pain"
Time frame: 10 to 12 weeks (last appointment)
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Time frame: 3 to 4 weeks (second appointment)
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Time frame: 10 to 12 weeks (last appointment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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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.
Luis G Alonso, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling and exercises and lifestyle counseling in people with Pain and Myofascial Pain, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 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 Brazil. 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?
Results are not available in the source record.
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?
pressure pain threshold (PPT) in Kilogram-force (Kgf) (time frame: at baseline (first appointment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2014.