Status:
ACTIVE_NOT_RECRUITING
The Costs and Effectiveness of Cognitive Functional Therapy for People with Persistent Low Back Pain in Coventry.
Lead Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 phy...
Eligibility Criteria
Inclusion
- Documented LBP for more than three months.
- Over 18 years old.
- Currently not working - either unemployed or in receipt of long-term sickness benefits at time of enrolment on the study.
- Living in 20% most deprived area of Coventry as defined by Index of Multiple Deprivation (IMD).
- Documented physical and/or mental health co-morbidities (e.g., anxiety, depression, obesity, diabetes, cardiovascular disease).
- Prescribed medications not currently recommended for LBP by NICE Guidelines - opioids, selective serotonin reuptake inhibitors, tricyclic antidepressants, antidepressants and/or gabapentinoids (NICE, 2020).
- Ability to provide informed consent.
Exclusion
- Lack capacity, or unable, to provide informed consent.
- Have signs and/or symptoms of serious spinal pathology (less than 2% of all people with LBP (Hartvisgen et al., 2018)) e.g., fracture, infection, acute loss of lower limb motor control, symptoms of cauda equina syndrome or cancer, acute inflammatory disease (e.g. ankylosing spondylitis).
- Have any medical condition that prevents from being physically active.
- Are currently pregnant or are three months post-partum.
- Are unable or unwilling to travel to CoCHC for the intervention.
Key Trial Info
Start Date :
December 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06161753
Start Date
December 28 2023
End Date
October 1 2025
Last Update
December 17 2024
Active Locations (1)
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1
City of Coventry Health Centre
Coventry, United Kingdom, CV2 2DX