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

Pain Clinical Trial

— PPT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02131714
• Other study ID #: TMD-2003
• Status: Active, not recruiting
• Phase: N/A
• First received: April 21, 2014
• Last updated: May 4, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: May 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Pain
• Myofascial Pain
• Myofascial Pain Syndromes
• Pain
• Temporomandibular Disorder Syndrome
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Therapeutic Exercise

Intervention

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
• lifestyle counseling

Locations

Country	Name	City	State
Brazil	Ambulatorio de Disfunção Temporomandibular e Dor Orofacial	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Yes
Other	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)	Yes
Other	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)	Yes
Other	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes