An interventional study of Cognitive Functional Therapy in Low Back Pain, sponsored by University Hospitals Coventry and Warwickshire NHS Trust. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by University Hospitals Coventry and Warwickshire NHS Trust · Not applicable, Interventional, and Treatment
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.
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 61 is close to the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University Hospitals Coventry and Warwickshire NHS Trust is the lead sponsor of 56 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
The Cognitive Functional Therapy arm will be subject to receiving the intervention, as described in the intervention section.
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.
Also known as: CFT
Number of Healthcare consultations
Number of healthcare contacts
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Prescribed medications, including dosage and frequency
Prescription medications, dosage and frequency
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Imaging requests
Requests for diagnostic imaging / work-up
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Referrals into secondary care
Referrals made into secondary care (e.g. Orthopaedics, Neurosurgery, Pain Clinic)
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Work status
Work status
Time frame: 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).
Time frame: Baselines; 13 weeks; 26 weeks
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).
Time frame: Baseline; 13 weeks; 26 weeks
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'.
Time frame: Baseline; 13 weeks; 26 weeks
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'.
Time frame: 13 weeks; 26 weeks
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'.
Time frame: Baseline; 13 weeks; 26 weeks
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?"
Time frame: Baseline; 13 weeks; 26 weeks
Plan to share: No
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University Hospitals Coventry and Warwickshire NHS Trust