Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Adrian Gardner
+44 121 685 4111
adrian.gardner@nhs.net


Prof Toby Helliwell
+44 1782 734895
t.helliwell@keele.ac.uk


Dr . Study Team MEDAL
-
medal@trials.bham.ac.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - The MEDAL Trial - MEDications in Acute Low back pain
Back

The MEDAL Trial - MEDications in Acute Low back pain

Recruiting

Open to: All Genders

Age: Adult

$location.addressLine3

Medical Conditions

Low back pain with or without leg pain or sciatica

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 May 2025 31 Jan 2028

A participant in the MEDAL trial would start at the bottom step of the ladder (step 1). 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 until they reach step 4. 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 will 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.


In the MEDAL trial we aim to randomise 3960 adults (18 years or over) with acute low back pain with or without leg pain or sciatica.

What does the study involve?
A participant in the MEDAL trial would start at the bottom step of the ladder (step 1). 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 until they reach step 4. 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 will 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.

You can take part if:



You may not be able to take part if:


1. More than 3 months of pain symptoms in this episode of pain2. 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 fracture6. History of drug misuse7. Currently taking regular analgesia (not including paracetamol and ibuprofen that could be bought over the counter) that has been prescribed by a health care professional8. Already enrolled in another clinical trial9. Onset of pain following significant trauma, such as a road traffic collision10. Ongoing litigation for spinal or musculoskeletal pain11. Currently pregnant or intending to become pregnant in the next 8 weeks12. Currently breastfeeding13. Undergoing active chemotherapy for cancer14. Listed on a palliative care register at a general practice or hospital


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

All medications used in the MEDAL trial are already part of standard of care for the treatment of lower back pain with or without leg pain or sciatica as part of the national formulary and have well characterised safety profiles. As a result, the MEDAL trial is considered a low risk trial.
A possible disadvantage of taking part is that the medication ladder the participant is allocated to does not fully address their pain. However, this would be a risk with any medication given by their GP. People with low back pain, with or without leg pain or sciatica, always have a chance of not getting better on medication.
Some people may experience side effects of the medications prescribed. Some people may require further help and treatment for their back pain, which could include the possibility of surgery. The risk of this happening is the same as if their GP were to prescribe pain medication in normal care, outside of the MEDAL trial.
There is not enough evidence for the medications used in this trial to be deemed safe during pregnancy. Therefore, some people will not be able to take part in the trial if they are female and currently pregnant, are planning to become pregnant or are unable to use appropriate contraception whilst in the MEDAL trial.

Dr . Study Team MEDAL
-
medal@trials.bham.ac.uk


Prof Toby Helliwell
+44 1782 734895
t.helliwell@keele.ac.uk


Prof Adrian Gardner
+44 121 685 4111
adrian.gardner@nhs.net



The study is sponsored by University of Birmingham and funded by National Institute for Health and Care Research.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN95580524

Or CPMS 60016

Last updated 11 September 2025

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top