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

Not Applicable

Active, not recruiting

• Conditions: Low Back Pain

• Registration Number: NCT06161753
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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 Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-08
• Study Start: 2023-12-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-05-01
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Imaging requests	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks	Requests for diagnostic imaging / work-up
Number of Healthcare consultations	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks	Number of healthcare contacts
Referrals into secondary care	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	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks	Prescription medications, dosage and frequency
Work status	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks	Work status
Quality Adjusted Life Years	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 Outcome Measures

Name	Time	Method
Roland-Morris Disability Questionnaire (RMDQ)	Baseline; 13 weeks; 26 weeks	Activity limitation and disability will be measured using the RMDQ. The RMDQ consists of 24 statements related to disability and activities of daily living. Respondents tick each statement that applies to them at the time of completion, giving a score between 0 (no disability) and 24 (maximum disability).
Patient Acceptable Symptoms State (PASS)	Baseline; 13 weeks; 26 weeks	Perceived level of symptom acceptability will be measured using the Patient Acceptable Symptoms State (PASS). The PASS asks the participant to answer a simple 'Yes' or 'No' answer to the question "Taking into account all of the activities you have during your daily life, your levels of pain, and also your functional impairment, do you consider that your current state is satisfactory?"
Numerical Pain Rating Scale (NPRS)	Baseline; 13 weeks; 26 weeks	Pain intensity will be measured using the Numerical Pain Rating Scale (NPRS). The NPRS asks a person to rate their pain intensity, on average over the previous week, on a scale of 0-10 (11 possible responses), where 0 implies 'no pain at all' and 10 is equal to 'pain as bad as you can imagine'.
Treatment Satisfaction	13 weeks; 26 weeks	Participant satisfaction with their allocated intervention will be measured using a simple satisfaction questionnaire containing four responses to the question "how satisfied were you with the care you received for your low back pain? 'Very dissatisfied', 'dissatisfied', 'neither satisfied or dissatisfied', 'satisfied' and 'very satisfied'.
Work Ability Index (WAI)	Baseline; 13 weeks; 26 weeks	Perceived ability to work will be measured using the Work Ability Index (WAI). The WAI asks a person to rate their current ability to work on a scale of 0-10 (11 possible responses), where 0 implies 'Currently cannot work at all' and 10 is equal to 'Work ability at its best'.

Trial Locations

Locations (1)

City of Coventry Health Centre; 🇬🇧 Coventry, United Kingdom