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The Costs and Effectiveness of Cognitive Functional Therapy for People With Persistent Low Back Pain in Coventry.

Low Back Pain Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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 and/or 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06161753
Study type Interventional
Source University Hospitals Coventry and Warwickshire NHS Trust
Contact Claire Finnie
Phone 02476966198
Email ResearchSponsorship@uhcw.nhs.uk
Status Recruiting
Phase N/A
Start date December 28, 2023
Completion date October 2024
View Details
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