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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Myofascial Pain; Facial Pain; Therapeutic Exercise; Temporomandibular Disorder Syndrome
• Intervention / Treatment: Behavioral: counseling and exercises; Behavioral: lifestyle counseling

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04023-061
    • Ambulatorio de Disfunção Temporomandibular e Dor Orofacial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: 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: lifestyle counseling; 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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral health impact profile - (OHIP-14) modified	It's a questionnaire to avaliate the impact profile of his temporomandibular joint condition and pain on his lifestyle.	at baseline (first appointment)
Catastrophizing scale of the coping strategies questionnaire (CSQ)	CSQ - coping strategies questionnaire To avaliate how catastrophizing toughts are present before and after treatment protocol was applied.	at baseline (first appointment)
oral health impact profile - (OHIP-14) modified	It's a questionnaire to avaliate the impact profile of his temporomandibular joint condition and pain on his lifestyle.	10 to 12 weeks (last appointment)
Catastrophizing scale of the coping strategies questionnaire (CSQ)	CSQ - coping strategies questionnaire To avaliate how catastrophizing toughts are present before and after treatment protocol was applied.	10 to 12 weeks (last appointment)

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Study Chair: Luis G Alonso, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: May 4, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 4, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: facial pain; therapeutic exercise; conservative treatment; pressure pain threshold; temporomandibular disorder syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain; Facies
• Other Study ID Numbers: TMD-2003