Low back pain Musculoskeletal Diseases
Conditions
Interventions
Eligible and consenting participants will be randomly allocated to receive either usual physiotherapy care or Cognitive Functional Therapy.
Cognitive Functional Therapy (CFT) is an individualised sel
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Dominant low back lasting for more than three months 2. Activity and/or functional limitations due to low back pain 3. A Numeric Pain Rating Scale (NPRS) score =3/10 during the last week 4. Being independently mobile to be capable of participating in a rehabilitation programme
Exclusion criteria
Exclusion criteria: 1. Leg pain as the primary problem (e.g. nerve root compression or disc prolapse with radicular pain/radiculopathy, lateral recess or central spinal stenosis) 2. Pain relieving interventional procedures in the preceding 3 months (e.g. facet joint denervation, caudal epidural injections) 3. Less than six months after lumbar spine, lower limb or abdominal surgery 4. Red flag disorders (malignancy/cancer, spinal fracture (less than six months ago), spinal infection or cauda equina syndrome) 5. Pregnancy or less than six months post-partum 6. Diagnosed psychiatric disorder that prevents engagement in a self-management intervention 7. Rheumatologic/inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis) 8. Progressive neurological disease (e.g. multiple sclerosis, Parkinson’s disease, motor neuron disease) 9. Unstable cardiac conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the feasibility of completing a future fully powered randomised controlled trial by; 1. Measuring eligibility, recruitment and retention rates of participants. 2. Measuring response rates to patient-reported outcome measures. 3. Decide the primary outcome measure for a definitive trial. 4. Calculate the sample size for the definitive RCT, should feasibility be assured. 5. Record any arising adverse events. 6. Evaluate intervention adherence. 7. Explore the acceptability of the intervention and the research process as experienced by participants and physiotherapists. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following patient-reported outcome measures will be collected at baseline, three, six and twelve-month follow-up periods; 1. Roland Morris Disability Questionnaire 2. Numeric Pain Rating Scale 3. Fear Avoidance Beliefs Questionnaire 4. Keele STarT Back Screening Tool 5. Pain Self-efficacy Questionnaire 6. Pain Catastrophising Scale 7. Distress, Anxiety and Stress Scale (DASS 21) 8. Euro-Qol (Eq-5D-5L) 9. Global Rating of Change and participant satisfaction will be collected at three, six and twelve-month follow-up only. 10. Working Alliance Theory of Change Inventory will be collected at three-month follow-up only. | — |
Countries
England, United Kingdom
Outcome results
None listed