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

NCT06161753 | Active Not Recruiting

• 1 other identifier: CN634623
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; population health management; cognitive functional therapy; health inequality

Outcome Measures

Primary Outcomes (6)

• Number of Healthcare consultations

  Number of healthcare contacts

  Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

• Prescribed medications, including dosage and frequency

  Prescription medications, dosage and frequency

  Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

• Imaging requests

  Requests for diagnostic imaging / work-up

  Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

• Referrals into secondary care

  Referrals made into secondary care (e.g. Orthopaedics, Neurosurgery, Pain Clinic)

  Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

• Work status

  Work status

  Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

• Quality Adjusted Life Years

  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).

  Baselines; 13 weeks; 26 weeks

Secondary Outcomes (5)

• Roland-Morris Disability Questionnaire (RMDQ)

  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

• Patient Acceptable Symptoms State (PASS)

  Baseline; 13 weeks; 26 weeks

Study Arms (1)

Cognitive Functional Therapy

EXPERIMENTAL

The Cognitive Functional Therapy arm will be subject to receiving the intervention, as described in the intervention section.

Behavioral: Cognitive Functional Therapy

Interventions

Cognitive Functional Therapy BEHAVIORAL

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.

Also known as: CFT

Cognitive Functional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

City of Coventry Health Centre

Coventry, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Newton

  University Hospitals Coventry and Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mixed-methods single cohort study

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 8, 2023
• Study Start: December 28, 2023
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)