Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542666
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Cognitive Functional Therapy for Chronic Shoulder Pain Pilot and Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain A Pilot and Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This pilot randomized controlled clinical trial RCT will assess the feasibility and identify the key components necessary for conducting the main RCT which will involve the comparison of Cognitive Functional Therapy with Therapeutic Exercises in individuals with chronic shoulder pain The main questions it aims to answer are
What barriers to the participation of the included individuals might arise
Will the assessment procedures and outcome measures be feasible and suitable
What time will be necessary to conduct the assessments
Will participants be willing to be randomized to the proposed treatment groups
What barriers to the clinical delivery of Cognitive Functional Therapy in the healthcare system might exist
Will the treatments be acceptable to patients
Will participants adhere to the treatment
What will the recruitment rates be per weekmonth
Will there be any selection bias
Will participant retention be high among the allocation groups
Will the data be complete
What will the data variability be
Will the treatment effectsoutcomes be consistent with expectations and previous literature
What barriers to the participation of the included individuals might arise
Will the assessment procedures and outcome measures be feasible and suitable
What time will be necessary to conduct the assessments
Will participants be willing to be randomized to the proposed treatment groups
What barriers to the clinical delivery of Cognitive Functional Therapy in the healthcare system might exist
Will the treatments be acceptable to patients
Will participants adhere to the treatment
What will the recruitment rates be per weekmonth
Will there be any selection bias
Will participant retention be high among the allocation groups
Will the data be complete
What will the data variability be
Will the treatment effectsoutcomes be consistent with expectations and previous literature
Detailed Description:
Shoulder pain is a potentially debilitating musculoskeletal condition with functional physical and psychological impact Its chronicity has been mainly correlated with affective-emotional and cognitive dimensions of pain In this scenario interventions for individuals with chronic shoulder pain should be seen within the biopsychosocial model In this context Cognitive Functional Therapy CFT emerges as a psychologically informed physiotherapeutic approach directed towards the biopsychosocial and multidimensional nature of pain which is divided into three approaches to reduce pain and disability 1 understanding pain 2 controlled exposure and 3 lifestyle change The present study aims to verify the feasibility and viability of a randomized clinical trial to compare the effects of Cognitive Functional Therapy with therapeutic exercises in individuals with chronic shoulder pain
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