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 Details — Status: Recruiting

Administrative data

• NCT number: NCT06161753
• Other study ID #: CN634623
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2023
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: Claire Finnie
• Phone: 02476966198
• Email: ResearchSponsorship[@]uhcw.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Cognitive Functional Therapy
CFT is an individualised, combined physical and behavioural approach specifically developed to target the multidimensional complexity of persistent LBP. CFT utilises a multidimensional clinical reasoning framework that enables the clinician to identify both modifiable and non-modifiable biopsychosocial factors (i.e. physical, cognitive, emotional, social, lifestyle and health comorbidities) underlying an individual's LBP. CFT targets these factors by: (1) helping the patient 'make sense of their pain' from a biopsychosocial perspective, (2) build confidence to engage in valued activities through functional movement training and (3) adopt positive lifestyle behaviours (O'Sullivan et al., 2018). Participants will receive approximately 7 treatment sessions over a 13-week period, although this will vary depending on participant needs, in line with the individualised nature of the intervention. Participants will be provided a booster session at 26 weeks to reinforce self-management.

Locations

Country	Name	City	State
United Kingdom	City of Coventry Health Centre	Coventry

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Healthcare consultations	Number of healthcare contacts	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Primary	Prescribed medications, including dosage and frequency	Prescription medications, dosage and frequency	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Primary	Imaging requests	Requests for diagnostic imaging / work-up	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Primary	Referrals into secondary care	Referrals made into secondary care (e.g. Orthopaedics, Neurosurgery, Pain Clinic)	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Primary	Work status	Work status	Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Primary	Quality Adjusted Life Years	Quality Adjusted Life Years will be calculated using the EQ5D-5L, a measure of health-related quality of life.	Baselines; 13 weeks; 26 weeks
Secondary	Roland-Morris Disability Questionnaire (RMDQ)	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).	Baseline; 13 weeks; 26 weeks
Secondary	Numerical Pain Rating Scale (NPRS)	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'.	Baseline; 13 weeks; 26 weeks
Secondary	Treatment Satisfaction	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'.	13 weeks; 26 weeks
Secondary	Work Ability Index (WAI)	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'.	Baseline; 13 weeks; 26 weeks
Secondary	Patient Acceptable Symptoms State (PASS)	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?"	Baseline; 13 weeks; 26 weeks