Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT06542666
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2024-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Functional Therapy for Chronic Shoulder Pain: Pilot and Feasibility Study
Sponsor:
Federal University of Paraíba
Organization:
Study Overview
Official Title:
Cognitive Functional Therapy Versus Therapeutic Exercises for Treating Individuals With Chronic Shoulder Pain: A Pilot and Feasibility Study
Status:
RECRUITING
Status Verified Date:
2025-02
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:
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 treatment(s) be acceptable to patients?
* Will participants adhere to the treatment?
* What will the recruitment rates be per week/month?
* 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 effects/outcomes 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 treatment(s) be acceptable to patients?
* Will participants adhere to the treatment?
* What will the recruitment rates be per week/month?
* 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 effects/outcomes 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:
False
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?: