Overview

This trial is active, not recruiting.

Conditions pain, myofascial pain, temporomandibular disorder syndrome, therapeutic exercise, facial pain
Treatments counseling and exercises, lifestyle counseling
Sponsor Federal University of São Paulo
Start date March 2014
End date May 2014
Trial size 100 participants
Trial identifier NCT02131714, TMD-2003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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
counseling and exercises
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
(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.
lifestyle counseling

Primary Outcomes

Measure
pressure pain threshold (PPT) in Kilogram-force (Kgf)
time frame: at baseline (first appointment)
pressure pain threshold (PPT) in Kilogram-force (Kgf)
time frame: 3 to 4 weeks (second appointment)
pressure pain threshold (PPT) in Kilogram-force (Kgf)
time frame: 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"
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)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Pressure Pain Threshold of Jaw Muscles in Patients With Facial Myofascial Pain Submitted to a Conservative Treatment : a Short-term Evaluation
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.