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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Number of Healthcare consultations
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •People registered with Coventry Central Primary Care PCN.
- •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.
Outcomes
Primary Outcomes
Number of Healthcare consultations
Time Frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Number of healthcare contacts
Referrals into secondary care
Time Frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Referrals made into secondary care (e.g. Orthopaedics, Neurosurgery, Pain Clinic)
Prescribed medications, including dosage and frequency
Time Frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Prescription medications, dosage and frequency
Imaging requests
Time Frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Requests for diagnostic imaging / work-up
Work status
Time Frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Work status
Quality Adjusted Life Years
Time Frame: Baselines; 13 weeks; 26 weeks
Quality Adjusted Life Years will be calculated using the EuroQol 5 Dimensions, 5 level version (EQ5D-5L) and the EuroQol Visual Analogue Scale (EQ-VAS), measure of health-related quality of life. The EQ5D-5L consists of five dimensions where the participant indicates their health state by ticking the box next to the most appropriate statement in each of the five dimensions from 1 (lowest impact) to 5 (highest impact). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-VAS requires the participant to score their overall health from 0 (worst health imaginable) to 100 (best health imaginable).
Secondary Outcomes
- Roland-Morris Disability Questionnaire (RMDQ)(Baseline; 13 weeks; 26 weeks)
- Patient Acceptable Symptoms State (PASS)(Baseline; 13 weeks; 26 weeks)
- Numerical Pain Rating Scale (NPRS)(Baseline; 13 weeks; 26 weeks)
- Treatment Satisfaction(13 weeks; 26 weeks)
- Work Ability Index (WAI)(Baseline; 13 weeks; 26 weeks)