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

Primary Purpose

Pain, Myofascial Pain, Temporomandibular Disorder Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
counseling and exercises
lifestyle counseling
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pressure pain threshold, temporomandibular disorder syndrome, therapeutic exercise, conservative treatment, facial pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ambulatorio de Disfunção Temporomandibular e Dor Orofacial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

counseling and exercises

lifestyle counseling

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 21, 2014
Last Updated
May 4, 2014
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02131714
Brief Title
Pressure Pain Threshold of Jaw Muscles in TMD Patients Submitted to a Conservative Treatment
Acronym
PPT
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Myofascial Pain, Temporomandibular Disorder Syndrome, Therapeutic Exercise, Facial Pain
Keywords
pressure pain threshold, temporomandibular disorder syndrome, therapeutic exercise, conservative treatment, facial pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
counseling and exercises
Arm Type
Active Comparator
Arm Description
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
Arm Title
lifestyle counseling
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
counseling and exercises
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
lifestyle counseling
Primary Outcome Measure Information:
Title
pressure pain threshold (PPT) in Kilogram-force (Kgf)
Description
-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.
Time Frame
at baseline (first appointment)
Title
pressure pain threshold (PPT) in Kilogram-force (Kgf)
Description
-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.
Time Frame
3 to 4 weeks (second appointment)
Title
pressure pain threshold (PPT) in Kilogram-force (Kgf)
Description
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.
Time Frame
10 to 12 weeks (last appointment)
Secondary Outcome Measure Information:
Title
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"
Description
- Visual analogue scale (VAS) for measuring pain.
Time Frame
at baseline (first appointment)
Title
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Description
- 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.
Time Frame
at baseline (first appointment)
Title
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"
Description
Visual analogue scale (VAS) for measuring pain.
Time Frame
3 to 4 weeks (second appointment)
Title
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"
Description
Visual analogue scale (VAS) for measuring pain.
Time Frame
10 to 12 weeks (last appointment)
Title
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Description
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.
Time Frame
3 to 4 weeks (second appointment)
Title
Verbal numerical scale (VNS) is a 11- point scale (0 to 10)
Description
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.
Time Frame
10 to 12 weeks (last appointment)
Other Pre-specified Outcome Measures:
Title
oral health impact profile - (OHIP-14) modified
Description
It's a questionnaire to avaliate the impact profile of his temporomandibular joint condition and pain on his lifestyle.
Time Frame
at baseline (first appointment)
Title
Catastrophizing scale of the coping strategies questionnaire (CSQ)
Description
CSQ - coping strategies questionnaire To avaliate how catastrophizing toughts are present before and after treatment protocol was applied.
Time Frame
at baseline (first appointment)
Title
oral health impact profile - (OHIP-14) modified
Description
It's a questionnaire to avaliate the impact profile of his temporomandibular joint condition and pain on his lifestyle.
Time Frame
10 to 12 weeks (last appointment)
Title
Catastrophizing scale of the coping strategies questionnaire (CSQ)
Description
CSQ - coping strategies questionnaire To avaliate how catastrophizing toughts are present before and after treatment protocol was applied.
Time Frame
10 to 12 weeks (last appointment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis G Alonso, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Ambulatorio de Disfunção Temporomandibular e Dor Orofacial
City
Sao Paulo
ZIP/Postal Code
04023-061
Country
Brazil

12. IPD Sharing Statement

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

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