Clinical trial NCT02131714: Pressure Pain Threshold of Jaw Muscles in TMD Patients Submitted to a Conservative Treatment
Official title: Pressure Pain Threshold of Jaw Muscles in Patients With Facial Myofascial Pain Submitted to a Conservative Treatment : a Short-term Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Myofascial Pain
Temporomandibular Disorder Syndrome
Therapeutic Exercise
Facial Pain
Keywords: pressure pain threshold
temporomandibular disorder syndrome
therapeutic exercise
conservative treatment
facial pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old have diagnosis of myofascial pain according RDC/TMD signed the informed consent

Exclusion Criteria:

* people under 18 years old

Primary outcomes:
measure: pressure pain threshold (PPT) in Kilogram-force (Kgf)
timeFrame: at baseline (first appointment)
measure: pressure pain threshold (PPT) in Kilogram-force (Kgf)
timeFrame: 3 to 4 weeks (second appointment)
measure: pressure pain threshold (PPT) in Kilogram-force (Kgf)
timeFrame: 10 to 12 weeks (last appointment)
Secondary outcomes:
measure: 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"
timeFrame: at baseline (first appointment)
measure: Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
timeFrame: at baseline (first appointment)
measure: 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"
timeFrame: 3 to 4 weeks (second appointment)
measure: 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"
timeFrame: 10 to 12 weeks (last appointment)
measure: Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
timeFrame: 3 to 4 weeks (second appointment)
measure: Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
timeFrame: 10 to 12 weeks (last appointment)
Other outcomes:
measure: oral health impact profile - (OHIP-14) modified
timeFrame: at baseline (first appointment)
measure: Catastrophizing scale of the coping strategies questionnaire (CSQ)
timeFrame: at baseline (first appointment)
measure: oral health impact profile - (OHIP-14) modified
timeFrame: 10 to 12 weeks (last appointment)
measure: Catastrophizing scale of the coping strategies questionnaire (CSQ)
timeFrame: 10 to 12 weeks (last appointment)
Locations:
city: Sao Paulo
country: Brazil
facility: Ambulatorio de Disfunção Temporomandibular e Dor Orofacial
Study officials:
affiliation: Federal University of São Paulo
name: Luis G Alonso, PhD
role: STUDY_CHAIR
References: