Low Back Pain Clinical Trial
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - People registered with Coventry Central Primary Care PCN. - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | City of Coventry Health Centre | Coventry |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Healthcare consultations | Number of healthcare contacts | Baseline (for preceding 13 weeks); 13 weeks; 26 weeks | |
Primary | Prescribed medications, including dosage and frequency | Prescription medications, dosage and frequency | Baseline (for preceding 13 weeks); 13 weeks; 26 weeks | |
Primary | Imaging requests | Requests for diagnostic imaging / work-up | Baseline (for preceding 13 weeks); 13 weeks; 26 weeks | |
Primary | Referrals into secondary care | Referrals made into secondary care (e.g. Orthopaedics, Neurosurgery, Pain Clinic) | Baseline (for preceding 13 weeks); 13 weeks; 26 weeks | |
Primary | Work status | Work status | Baseline (for preceding 13 weeks); 13 weeks; 26 weeks | |
Primary | Quality Adjusted Life Years | Quality Adjusted Life Years will be calculated using the EQ5D-5L, a measure of health-related quality of life. | Baselines; 13 weeks; 26 weeks | |
Secondary | 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). | Baseline; 13 weeks; 26 weeks | |
Secondary | 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'. | Baseline; 13 weeks; 26 weeks | |
Secondary | 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'. | 13 weeks; 26 weeks | |
Secondary | 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'. | Baseline; 13 weeks; 26 weeks | |
Secondary | 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?" | Baseline; 13 weeks; 26 weeks |
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