Clinical trial NCT06161753: The Costs and Effectiveness of Cognitive Functional Therapy for People with Persistent Low Back Pain in Coventry.
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
population health management
cognitive functional therapy
health inequality
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: mixed-methods single cohort study
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of Healthcare consultations
timeFrame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
measure: Prescribed medications, including dosage and frequency
timeFrame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
measure: Imaging requests
timeFrame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
measure: Referrals into secondary care
timeFrame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
measure: Work status
timeFrame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
measure: Quality Adjusted Life Years
timeFrame: Baselines; 13 weeks; 26 weeks
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline; 13 weeks; 26 weeks
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline; 13 weeks; 26 weeks
measure: Treatment Satisfaction
timeFrame: 13 weeks; 26 weeks
measure: Work Ability Index (WAI)
timeFrame: Baseline; 13 weeks; 26 weeks
measure: Patient Acceptable Symptoms State (PASS)
timeFrame: Baseline; 13 weeks; 26 weeks
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: City of Coventry Health Centre
Study officials:
affiliation: University Hospitals Coventry and Warwickshire NHS Trust
name: Christopher Newton
role: PRINCIPAL_INVESTIGATOR
References: