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

NCT ID: NCT06161753

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-28

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Keywords

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low back pain population health management cognitive functional therapy health inequality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

mixed-methods single cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive Functional Therapy

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

Group Type EXPERIMENTAL

Cognitive Functional Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CFT

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Newton

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Coventry and Warwickshire NHS Trust

Locations

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City of Coventry Health Centre

Coventry, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CN634623

Identifier Type: -

Identifier Source: org_study_id