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Active, Not Recruiting

NCT Number: NCT06161753

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Coventry Health Centre

Coventry, CV2 2DX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: CFT

Primary outcomes

  1. Number of Healthcare consultations

    Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

    Number of healthcare contacts

  2. Prescribed medications, including dosage and frequency

    Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

    Prescription medications, dosage and frequency

  3. Imaging requests

    Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

    Requests for diagnostic imaging / work-up

  4. Referrals into secondary care

    Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

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

  5. Work status

    Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks

    Work status

  6. Quality Adjusted Life Years

    Time frame: 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 outcomes

  1. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 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).

  2. Numerical Pain Rating Scale (NPRS)

    Time frame: 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'.

  3. Treatment Satisfaction

    Time frame: 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'.

  4. Work Ability Index (WAI)

    Time frame: 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'.

  5. Patient Acceptable Symptoms State (PASS)

    Time frame: 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?"

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2023
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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