Low Back PainNCT06161753
The Costs and Effectiveness of Cognitive Functional Therapy for People with Persistent Low Back Pain in Coventry.
A study testing Cognitive Functional Therapy in people with Low Back Pain, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Cognitive Functional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Dec 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed 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.
- Conditions
- Low Back Pain
- Being tested
- Cognitive Functional Therapy
- Keywords
- low back pain, population health management, cognitive functional therapy, health inequality
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Functional TherapyBehavioural
Also called CFT
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Functional Therapy | Experimental | The Cognitive Functional Therapy arm will be subject to receiving the intervention, as described in the intervention section. Receives: Behavioral: Cognitive Functional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Healthcare consultations
Number of healthcare contacts
Measured: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Prescribed medications, including dosage and frequency
Prescription medications, dosage and frequency
Measured: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Imaging requests
Requests for diagnostic imaging / work-up
Measured: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Referrals into secondary care
Referrals made into secondary care (e.g. Orthopaedics, Neurosurgery, Pain Clinic)
Measured: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Work status
Work status
Measured: 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).
Measured: Baselines; 13 weeks; 26 weeks
Secondary outcomes (5)
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).
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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?"
Measured: Baseline; 13 weeks; 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start28 Dec 2023
- Primary completion1 May 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- mixed-methods single cohort study
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Newton, Principal investigator, University Hospitals Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161753
- Sponsor's protocol ID
- CN634623
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06161753
- Acronym / sponsor ID
- CN634623
- Conditions
- Low Back Pain
- Keywords
- low back pain, population health management, cognitive functional therapy, health inequality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- mixed-methods single cohort study
| Arm | Type | Receives |
|---|---|---|
| Cognitive Functional Therapy | Experimental | Behavioral: Cognitive Functional TherapyThe Cognitive Functional Therapy arm will be subject to receiving the intervention, as described in the intervention section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Functional TherapyAlso: CFTCFT 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. | Behavioural | Cognitive Functional Therapy |
Primary outcome
Number of Healthcare consultations
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Number of healthcare contacts
Prescribed medications, including dosage and frequency
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Prescription medications, dosage and frequency
Imaging requests
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Requests for diagnostic imaging / work-up
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)
Work status
Time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks
Work status
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).
5 secondary outcomes
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Baseline; 13 weeks; 26 weeks
Numerical Pain Rating Scale (NPRS)
Time frame: Baseline; 13 weeks; 26 weeks
Treatment Satisfaction
Time frame: 13 weeks; 26 weeks
Work Ability Index (WAI)
Time frame: Baseline; 13 weeks; 26 weeks
Patient Acceptable Symptoms State (PASS)
Time frame: Baseline; 13 weeks; 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Newton principal investigator
University Hospitals Coventry and Warwickshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Functional Therapy in people with Low Back Pain, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Healthcare consultations (time frame: Baseline (for preceding 13 weeks); 13 weeks; 26 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.