Pressure Pain Threshold of Jaw Muscles in TMD Patients Submitted to a Conservative Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Pressure Pain Threshold of Jaw Muscles in Patients With Facial Myofascial Pain Submitted to a Conservative Treatment : a Short-term Evaluation

Conditions
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Pain, Myofascial Pain, Temporomandibular Disorder Syndrome, Therapeutic Exercise, Facial Pain

Intervention / Treatment
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* Behavioral: counseling and exercises
* Behavioral: lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: counseling and exercises<br>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 | Behavioral: counseling and exercises<br>* 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<br>|
| Placebo Comparator: lifestyle counseling<br>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. | Behavioral: lifestyle counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 10 to 12 weeks (last appointment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 10 to 12 weeks (last appointment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure pain threshold, temporomandibular disorder syndrome, therapeutic exercise, conservative treatment, facial pain