Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502769
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders a Single-blind Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders TMD One group will receive isolated therapeutic exercise TE and the other will receive TE combined with pain neurophysiology education PNE The hypothesis of this study is that the PNETE group will obtain superior therapeutic results than an isolated TE program
Detailed Description:
Objective To evaluate the differences in pain intensity by performing isolated therapeutic exercise TE versus performing the same exercise combined with pain neurophysiology education PNE in patients with temporomandibular disorders TMD
Design Single-blind randomized controlled trial Setting Faculty of Physical Therapy of Alcalá de Henares Participants Subjects with TMD lasting more than 6 months N 36 Interventions Participants will be randomly assigned to receive a TE program consisting of stretching coordination and strengthening exercises n 18 or the same TE program in addition to a PNE program n 18 performed in two sessions of 40 minutes in groups of 6 participants The intervention will last 12 weeks where all participants must complete the exercise program daily one year later they will be evaluated again
Main outcome measures The primary outcome will be pain intensity through the visual analogue scale VAS which will be completed at baseline immediately after treatment at 4 and 12 weeks and one year after treatment Secondary outcome measures include pain-free mouth opening Craniofacial Pain and Disability Inventory CF-PDI Pain Catastrophizing Scale PCS Tampa Scale for Kinesiophobia for Temporomandibular Disorders TSK-11 pressure pain thresholds PPT and Patient Global Impression of Change PGIC They will be recorded through blinded assessments performed by 2 physiotherapists at baseline immediately after treatment 4 and 12 weeks after treatment Students t test will be used to determine differences between group interventions
Design Single-blind randomized controlled trial Setting Faculty of Physical Therapy of Alcalá de Henares Participants Subjects with TMD lasting more than 6 months N 36 Interventions Participants will be randomly assigned to receive a TE program consisting of stretching coordination and strengthening exercises n 18 or the same TE program in addition to a PNE program n 18 performed in two sessions of 40 minutes in groups of 6 participants The intervention will last 12 weeks where all participants must complete the exercise program daily one year later they will be evaluated again
Main outcome measures The primary outcome will be pain intensity through the visual analogue scale VAS which will be completed at baseline immediately after treatment at 4 and 12 weeks and one year after treatment Secondary outcome measures include pain-free mouth opening Craniofacial Pain and Disability Inventory CF-PDI Pain Catastrophizing Scale PCS Tampa Scale for Kinesiophobia for Temporomandibular Disorders TSK-11 pressure pain thresholds PPT and Patient Global Impression of Change PGIC They will be recorded through blinded assessments performed by 2 physiotherapists at baseline immediately after treatment 4 and 12 weeks after treatment Students t test will be used to determine differences between group interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None