Low back pain Musculoskeletal Diseases
Conditions
Interventions
The design of the study is a randomised controlled trial with a recruitment target of 270 patients who have had and still have persistent LBP for 6 months or more. (It is crucial for this study that p
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years 2. Episode of Low Back Pain (lasting >=6 months) 3. Low Back Pain is >=6 on a 0-10 Numerical Rating Score (NRS) 4. Have undergone previous non-surgery treatment that aligns with best practice guidelines (National Institute of Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management (Clinical Guideline [NG59]) London 2016. Sect. 1.9), e.g.: 4.1. A course of physical therapy 4.2. A course of psychological therapy 4.3. A course of treatment from a multi-disciplinary team 4.4. A course of treatment from specialist medical care 4.5. Medial branch blocks/radiofrequency denervation 4.6. Analgesia 5. Willing and able to provide informed consent 6. Recent evidence (within the last 12 months) of lumbar degenerative disease using appropriate imaging (Magnetic Resonance Imaging [MRI] +/- Single Photon Emission Computed Tomography/Computed Tomography [SPECT/CT), +/- previous discectomy/decompression 7. Suitable for both lumbar fusion surgery (LFS) at 1 or 2 lumbar spine levels and best conservative care (BCC)
Exclusion criteria
Exclusion criteria: 1. Has low-back related leg pain more severe than low back pain, e.g. claudication 2. Pain in any other body region more severe than low back pain 3. Previous (or attempted) LFS 4. Has psychiatric disorders (e.g. diagnosed personality disorders, post-traumatic stress disorder, drug or alcohol abuse/addiction, diagnosis of severe depression). 5. Radiculopathy or claudication or clinical signs of nerve decompression where the treatment plan includes offering a direct or indirect decompression along with the fusion 6. Any other reasons indicated for lumbar fusion surgery (LFS), e.g. deformity, infection, tumours, instability (due to spondylolisthesis of grade 2 or above), spinal fracture, systematic inflammatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low back pain (LBP) related physical function is measured using the Oswestry Disability Index (ODI) at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Low back pain (LBP) intensity is measured monthly using the Numerical Rating Scale (NRS on a scale 1-10) 2. Low back pain (LBP) related physical function is also measured using the Oswestry Disability Index (ODI) at baseline, 6 and 12 months 3. Cost-effectiveness will be measured with: 3.1. Quality of Life using the EQ-5D-5L at baseline, 6, 12 and 24 months 3.2. Pain Self-efficacy Questionnaire (PSEQ) at baseline, 6, 12 and 24 months 3.3. Patient Health Questionnaire (PHQ-8) at baseline, 6, 12 and 24 months 3.4. Tampa Scale of Kinesiophobia (TSK) at baseline, 6, 12 and 24 months 3.5. Global Perceived Effect Scale (GPE) at baseline, 6, 12 and 24 months 3.6. Healthcare Resources Use at baseline, 6, 12 and 24 months 3.7. Work status at baseline, 6, 12 and 24 months 3.8. Treatment Satisfaction at 24 months | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Contacts
Public ContactOdette;Study team contact Dawkins;-
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Outcome results
None listed