SIAMESE
Research type
Research Study
Full title
Supraneural versus Infraneural Approach to transforaMinal Epidural StEroid injection for unilateral lumbosacral radicular pain (SIAMESE): A randomised controlled non-inferiority trial.
IRAS ID
1005202
Contact name
Helen Galley
Contact email
Sponsor organisation
NHS Grampian
Eudract number
2022-000679-38
ISRCTN Number
ISRCTN36195887
Research summary
Sciatica is due to compression of the nerves in the lower back, resulting in back and hip pain which radiates down the back of the thigh and the leg. It is routinely treated with epidural steroid injection.
The most common type of epidural for sciatica is called a transforaminal epidural, where the needle is inserted into the area where nerves exit the spinal cord. The standard way of performing this injection, called the supraneural method, has a good safety profile, but there have been very rare reports of catastrophic injury. This is thought to be due to damage to a specific artery. An alternative method, called the infraneural approach, avoids this artery. Both epidurals are effective, and both are routinely used in Aberdeen.
This is a ‘non-inferiority trial’ to show that the efficacy of the infraneural approach is not worse than supraneural in terms of pain, disability and sleep after 3 months.
Patients with sciatic pain who are scheduled for epidural will be recruited and will be randomly assigned for epidural using one of the two techniques. Only the doctor giving the epidural will know which technique has been used.
Participants will wear an activity watch for a week before their treatment and will input daily pain scores. They will also complete questionnaires on pain, function and sleep and will followed up for a total of a year.
We will determine the difference between the effect of the two epidural techniques. After the study, we will also ask participants to provide feedback to ensure their views contribute to future study design.
This study will tell us if the infraneural epidural technique is as good as supraneural for treatment of sciatic pain. The results will inform us whether routine use of the infraneural technique should be recommended.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0245
Date of REC Opinion
14 Nov 2022
REC opinion
Further Information Favourable Opinion