Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161753
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-11-28
Brief Title:
The Costs and Effectiveness of Cognitive Functional Therapy for People with Persistent Low Back Pain in Coventry
Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Organization:
University Hospitals Coventry and Warwickshire NHS Trust
Study Overview
Official Title:
The Costs and Effectiveness of Cognitive Functional Therapy for People with Persistent Low Back Pain Multi-morbidity and Affected by Health Inequality a Primary Care Mixed Methods Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Previous studies have shown Cognitive Functional Therapy CFT results in sustained clinically important improvements compared to a variety of interventions for persistent low back pain LBP However CFT is yet to be evaluated in people with persistent LBP who are affected by health inequality and multimorbidity despite the strong association between LBP socioeconimic deprivation multimorbidity and increased prevalance in people from minority ethnic backgrounds This study will aim to examine the cost and effectiveness of CFT in a population living with LBP adversely affected by health inequality and multimorbidity in areas of social deprivation in Coventry United Kingdom
Detailed Description:
This study will be conducted in two phases In Phase 1 a single cohort study will be conducted whereby Cognitive Functional Therapy CFT will be delivered to 150 participants recruited from the physiotherapy waiting list
Healthcare utilisation data will be collected retrospectively from participants electronic health records and the physiotherapy referral information for the 13 weeks before the date of enrolment Clinical outcomes will be collected at baseline prior to participants beginning the intervention Both healthcare utilisation and clinical outcomes will be collected on two further occasions at 13 and 26 weeks CFT will be delivered by six physiotherapists who have undergone a comprehensive training programme and demonstrated ability to deliver the intervention to a competency standard assessed by a CFT tutor using a predefined competency framework used in previous CFT studies Treatment fidelity will be assessed throughout the study
In Phase 2 qualitative semi-structured interviews andor dyad interviews will be conducted with at least 10 participants and their treating physiotherapist This aims to explore the experiences and acceptability of the intervention for people from this population the intervention training and the study of participants and physiotherapists
Healthcare utilisation data will be collected retrospectively from participants electronic health records and the physiotherapy referral information for the 13 weeks before the date of enrolment Clinical outcomes will be collected at baseline prior to participants beginning the intervention Both healthcare utilisation and clinical outcomes will be collected on two further occasions at 13 and 26 weeks CFT will be delivered by six physiotherapists who have undergone a comprehensive training programme and demonstrated ability to deliver the intervention to a competency standard assessed by a CFT tutor using a predefined competency framework used in previous CFT studies Treatment fidelity will be assessed throughout the study
In Phase 2 qualitative semi-structured interviews andor dyad interviews will be conducted with at least 10 participants and their treating physiotherapist This aims to explore the experiences and acceptability of the intervention for people from this population the intervention training and the study of participants and physiotherapists
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