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

NCT02131714 | Unknown

• 1 other identifier: TMD-2003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Myofascial Pain; Temporomandibular Disorder Syndrome; Therapeutic Exercise; Facial Pain

Keywords

pressure pain threshold; temporomandibular disorder syndrome; therapeutic exercise; conservative treatment; facial pain

Outcome Measures

Primary Outcomes (3)

• 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 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"

  at baseline (first appointment)

• Verbal numerical scale (VNS) is a 11- point scale (0 to 10)

  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"

  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"

  10 to 12 weeks (last appointment)

• Verbal numerical scale (VNS) is a 11- point scale (0 to 10)

  3 to 4 weeks (second appointment)

Other Outcomes (4)

• oral health impact profile - (OHIP-14) modified

  at baseline (first appointment)

• Catastrophizing scale of the coping strategies questionnaire (CSQ)

  at baseline (first appointment)

• oral health impact profile - (OHIP-14) modified

  10 to 12 weeks (last appointment)

Study Arms (2)

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

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.

Behavioral: lifestyle counseling

Interventions

counseling and exercises BEHAVIORAL

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

lifestyle counseling BEHAVIORAL

lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• people under 18 years old

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Ambulatorio de Disfunção Temporomandibular e Dor Orofacial

São Paulo, São Paulo, 04023-061, Brazil

Location

MeSH Terms

Conditions

Pain; Facial Pain

Interventions

Counseling; Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Luis G Alonso, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: May 6, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

BR (1)