MEDAL
Research type
Research Study
Full title
The pharmacological management of back pain and sciatica in adults: a pragmatic, randomised controlled adaptive platform trial of analgesic ladders.
IRAS ID
1007662
Contact name
Adrian Gardner
Contact email
Sponsor organisation
University of Birmingham
ISRCTN Number
ISRCTN95580524
Research summary
Low back pain, with or without leg pain or sciatica is very common and affects many adults. Unfortunately, it can be very painful and disabling and many of those that suffer take a variety of different pain killing medications to help them cope. It is not clear which medications, either on their own, or in combination with others, gives the best relief from pain. This trial is designed to answer that question.
In order to answer the question of what is the most effective pain relief for low back pain with or without leg pain or sciatica, we have designed a clinical trial to take place in GP surgeries in the UK using analgesic ladders. Analgesic ladders are a combination of analgesic (pain-relieving) medication taken in a step wise fashion, adding to what has already been prescribed in response to how much pain the participant is in. In the MEDAL trial there are six pre-defined analgesic ladders with six steps (i.e. medications) in each ladder. All medications used in the MEDAL trial are already prescribed for low back pain with or without leg pain or sciatica. However this trial is designed to provide a set way to approach treating this condition which can be applied nationally and provide the most effective pain relief.
In the MEDAL trial we aim to randomise 3960 adults with acute low back pain with or without leg pain or sciatica. A participant in the MEDAL trial would start at the bottom step of the ladder. If their pain is not improved after 3 whole days of taking the medication, the participant can then take the next step of the ladder and so on. This process continues until the participant feels ‘quite a lot better’ as determined by questions a participant completes daily, up to 8 weeks post randomisation. If the participant is still in pain after 8 weeks, they return back to standard of care with their GP.
We will assess the success of the ladders by asking questions about work, sleep and daily life during and after the medication finishes.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0280
Date of REC Opinion
27 Sep 2024
REC opinion
Further Information Favourable Opinion