The MEDAL Study
About the study
The MEDAL Study will investigate how best to treat low back pain, leg pain or sciatica and will help tackle one of the biggest health problems in the UK.
Aim of the study
The MEDAL Study will provide scientific evidence of potential medication options for those involved in treating a problem that significantly impacts individuals, society and the economy.
The primary objective will be to assess which analgesic ladder is the most effective in the management and resolution of pain in those presenting with either 1) Acute Lower Back Pain (LBP), 2) Acute LBP and referred somatic leg pain, or 3) Neuropathic leg pain (sciatica) +/- acute LBP.
Current enrolment curve
Recruitment target: 3960
Information about the Study
Study Design
A multi-centre, open label, individually randomised controlled, adaptive platform trial in Primary Care, recruiting patients from three separate clinical scenarios with an integrated health economic evaluation and internal pilot with embedded qualitative process evaluation.
Primary outcome measure
A time to event outcome when, using the Patient Global Impression of Change (PGIC) scale daily, measures of self-scoring are ≥4 points (a change from ‘no improvement’ to at least ‘quite a lot better’) for 5 consecutive days.
Things to Know
The findings from this study will provide valuable guidance for GPs and Healthcare Professionals so that they can offer the most effective medication(s) for the management of acute low back pain / leg pain and sciatica. This will inform future NICE guidelines in this field. Dissemination will be through the media, conferences, journal articles and future clinical guidelines.
Timelines for delivery
36 months recruitment, including a 9 month pilot phase, 6 months follow up from last recruitment.
Participant Population
We aim to recruit 3960 adults with symptoms of less than 3 months duration that class as either (1) Acute LBP (2) Acute LBP with referred somatic leg pain or (3) Neuropathic leg pain (sciatica) +/- acute LBP.
Study Funders
The study is funded by the National Institute of Health and Care Research (NIHR). The sponsor is the University of Birmingham.
Study Team
Professor Adrian Gardner
Chief Investigator
Professor of Clinical Practice in Orthopaedic Surgery at Aston University and Spinal Surgeon at The Royal Orthopaedic Hospital NHS Foundation Trust
Professor Gardner trained in orthopaedics and spinal surgery in Birmingham and Leeds prior to his appointment at the Royal Orthopaedic Hospital in 2009. He was recently appointed as the first professor of clinical practice in orthopaedics by Aston University, Birmingham, in partnership with the Royal Orthopaedic Hospital. His interests are in improving health for people with back conditions.
Professor Toby Helliwell
Joint Lead Applicant
Professor of General Practice at Keele University and Midlands Partnership University NHS Foundation Trust (MPFT)
During his academic career Professor Helliwell has completed a Masters degree in medical science and a PhD in musculoskeletal general practice. He is a general practitioner by background and professor of General Practice at Keele University, a Fellow of the Royal College of General Practitioners and works as a specialty lead for the Research Delivery Network in the West Midlands as well as being part of the global health team at Keele University having been part of the team since its inception. His interests are wide but his main focus is in improving community health particularly around disabling and painful conditions.