Low back pain with or without leg pain or sciatica Musculoskeletal Diseases
Conditions
Interventions
MEDAL will be comparing six different analgesic ladders of medication in the management of three different types of LBP and leg pain. Participants will be randomised by their GP to one of six analgesi
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. A clinical diagnosis of acute low back pain +/- low back related leg pain, or sciatica of no more than 3 months duration N.B. This includes individuals with an acute flare up of back and/or leg pain on the background of low-grade symptoms – numerical rating scale (NRS) for pain of = 3 - and in the preceding one month have not had severe pain requiring substantial use of analgesia. 3. Must understand spoken and written English N.B. If unable to write in English for themselves, they must have someone in their home who can understand written English to help with consent and data capture.
Exclusion criteria
Exclusion criteria: 1. More than 3 months of pain symptoms in this episode of pain 2. Other previously diagnosed spinal pathology (e.g., scoliosis, kyphosis, spondylolisthesis, spinal stenosis, systemic inflammatory disease) 3. Inability to take any of the medications to be used in the study for any reason (specified co-morbidities, drug interactions, known allergies) 4. Neurological deficit requiring an urgent surgical assessment (e.g., cauda equina syndrome or ‘foot drop’) 5. Clinical suspicion (red flags) or known diagnosis of spinal malignancy, infection, or fracture 6. History of drug misuse 7. Currently taking regular analgesia (not including paracetamol and ibuprofen that could be bought over the counter) that has been prescribed by a health care professional 8. Already enrolled in another clinical trial 9. Onset of pain following significant trauma, such as a road traffic collision 10. Ongoing litigation for spinal or musculoskeletal pain 11. Currently pregnant or intending to become pregnant in the next 8 weeks 12. Currently breastfeeding 13. Undergoing active chemotherapy for cancer 14. Listed on a palliative care register at a general practice or hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will have been reached when, using the Patient Global Impression of Change (PGIC) pain scale, the self-assessment scores reach 4 points or more (going from 'no improvement' to at least 'quite a lot better') for 5 days in a row. Daily measurements will be collected until 8 weeks after randomisation. The PGIC scale ranges from -5 to +5, with 0 indicating no change. Higher positive numbers show improvement, while negative numbers indicate worsening. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcomes collected daily for 8 weeks are: 1.The intensity of pain using the Numerical Rating Scale (NRS) of pain. Score of 0 to 10 (10 is the worst pain you can imagine) 2.The number and type of any serious side effects Outcomes measured at 4, 8 weeks and 26 weeks after randomisation are: 3. Patient self-assessment of resolution of symptoms 4.The level of back-related function and disability of daily activities using the Oswestry Disability Index (ODI). 5. If their pain has disturbed their sleep in the past week (Yes/No). 6. Percent overall work impairment using the Work Productivity and Activity Impairment (WPAI) scale. 7. Mental health using the Depression, Anxiety and Positive Outlook Scale (DAPOS). 8. Health-related quality of life using the EQ-5D-5L. 9. Relapse of pain. Determined by asking if pain has relapsed after the end of the medication. 10. Admission to hospital related to the back pain/leg pain/sciatica or the medications given. We will also record and report descriptively, but without making formal comparisons: 11. The number and type of side effects / adverse events 12. The type, and quantity, of other treatments undertaken on top of the medication in the trial (physical, topical, other medications/analgesics etc.) | — |
Countries
England, United Kingdom
Contacts
Public Contact. Study Team MEDAL
Outcome results
None listed