Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259344
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-02-06
Brief Title:
Pain Science Education Administered in Full or Fractioned Dosage Modes for Temporomandibular Disorders
Sponsor:
Universidade Federal de Sao Carlos
Organization:
Universidade Federal de Sao Carlos
Study Overview
Official Title:
Effect of Pain Science Education Administered in Full or Fractioned Dosage Modes Associated With Conventional Treatment on Pain Intensity and Disability for Temporomandibular Disorders a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Temporomandibular Disorders TMD are a collection of musculoskeletal disorders which affect the masticatory structures and have a multifactorial etiology A biopsychosocial approach is recommended for the management of these disorders including different interventions like exercise manual therapy and pain education The aim of this study is to compare the effect of a full dosage mode pain science education program 2 initial sessions of 45 minutes versus a fractioned dosage format 6 sessions of 15 minutes combined with manual therapy and orofacial exercises on primary outcomes - pain intensity and disability - and secondary outcomes - mandibular range of motion pain-related self-efficacy kinesiophobia global perception of improvement empathy knowledge about pain neuroscience beliefs about pain exercise adherence and catastrophizing - in patients with chronic painful TMD This study will be a randomized controlled trial with a sample of 148 participants Individuals will undergo a screening process to identify those with TMD diagnosis according to the Diagnostic Criteria for Temporomandibular Disorders DCTMD aged 20 to 60 years of both genders and then the volunteers will be randomized into two groups G1 Full dosage mode pain science education program Manual therapyorofacial and neck motor exercises vs G2 Fractioned dosage mode pain science education program Manual therapyorofacial and neck motor exercises These volunteers will be recruited in the city of São Carlos SP The intervention will take place twice a week for 8 weeks administered by a single therapist each session lasting 1 hour The primary outcomes will be pain intensity and disability assessed using the numerical pain rating scale and the Craniofacial Pain and Disability Inventory CFP-DI respectively and the secondary outcomes will be mandibular range of motion pain-related self-efficacy kinesiophobia global perception of improvement empathy knowledge about pain neuroscience beliefs about pain exercise adherence and catastrophizing assessed using the Tampa Scale for Kinesiophobia for Temporomandibular Disorders TSK-TMD Global Perceived Effect of Improvement scale Pain Self-Efficacy Questionnaire PSEQ CARE Empathy Scale and Pain Catastrophizing Scale PCS For statistical analysis a Generalized Estimated Equations considering time and groups as factors will be used A significance level of p005 will be considered
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None