Information for Patients - What is involved? 

NERVES is a research study to compare two commonly used treatments for sciatic pain caused by a prolapsed disc.
The two treatments that are being compared are a form of injection (transforaminal epidural steroid injection) and surgery (microdiscectomy).
At the moment, we don't know which of these commonly used treatments works best so we want to compare the treatments to work out which is most helpful in reducing sciatic leg pain.  In the NERVES trial we want to find out if one treatment works better than the other and to do this we are inviting patients who meet our criteria to take part. Across the UK we recruited 163 patients from participating hospitals and clinics.


Why are we doing the NERVES trial?

Your spine (backbone) is made up of several bones called vertebrae seperated by cushion-like discs. If these discs become damaged the jelly-like substance from the middle of the disc can bulge out. This can cause inflammation of the nearby nerves at the base of the spine and result in severe pain in the back and down one or both legs. This pain is called sciatica.
The vast majority of sciatica gets better on its own but if it lasts more than 6 weeks there are two treatments generally offered:
- Transforaminal epidural steroid injection (TFESI)
- Surgical microdiscectomy
These two treatments work in different ways to help reduce pain and are offered to patients who have had other types of treatment, like painkillers, but who are still experiencing pain.


What will I have to do if I take part?

If you have decided to take part you we expect that you will have 4 study visits to the hospital and these will occur at the same time as routine clinic visits where possible:
Visit 1 - initial appointment following GP referral
Visit 2 - treatment visit
Visit 3 - follow up appointment (approximately 18 weeks after Visit 1)
Visit 4 - follow up appointment (approximately 54 weeks after Visit 1)


Patient Visit Schedule

At the visits you may have a routine physical exam and be asked the same medical questions you would be asked at a normal clinic appointment. There will be an study questionnnaire to complete at each visit asking about your symptoms and pain and how they affect you on a day to day basis. The research team can help you complete this if you like.
We will also send the same questionnaire out to you by post to complete at home at 30 and 42 weeks after your first visit. By collecting information regularly we should be able to build a complete picture of how your symptoms might have changed over time and how your sciatica has impacted your life. This information should help us see which treatment has helped patients the most.

How will I know which treatment I will have?
Patients that take part in NERVES will be split into two groups by a computer. If you decide to take part in NERVES the computer will randomly choose whether you will receive the injection or surgery and you will find out which treatment you will receive at the first visit if possible.

Further information on the treatments offered will be provided by the research team.


What are the possible risks of taking part?
The treatments used in NERVES are the same as those you would be offered if you were not taking part, so there are no extra risks as a result of participating. Both treatments are considered to be low-risk as the majority of patients do not have any complications. Your healthcare team will be able to give you more information about the advantages and disadvantages of each treatment, and explain any risks that you should be aware of. Your healthcare team are experts in this field and will try to make your treatment as safe as possible.

What are the possible benefits of taking part?
Both treatments have been shown to improve symptoms but because this is a research study we cannot say for sure that you will benefit directly from it. We hope that the information we learn from the research will help doctors and patients in the future when choosing treatment for sciatica.

Will my participation be kept confidential?
Yes. We will follow ethical and legal practice and all information which is collected about you during the course of the study will be kept strictly confidential. With your consent, we will send a letter to your GP to let them know you are taking part and we wull use your NHS number and postcode to access anonymised data about your hospital admissions. This will, for example, involve sharing your personal details with NHS Digital so they can share anonymised data they hold about your hospital attendances with the NERVES research team. Any named data (such as the consent form you will complete to confirm your participation) that has to be sent to the coordinating centre for the study (the CTRC) will only be accessed by people working on the study or working to ensure the study is being run correctly.

Withdrawal
In consenting to the study, participants are consented to the study intervention, follow-up and data collection. This means you have given your consent to take part in the study and for the doctors and nurses looking after you to collect information about your treatment and how you are doing on forms used only for the study. You have also given your consent for information routinely collected by hospitals and laboratories to be used as part of the study analysis.

If you no longer wish to be involved in the study this is called withdrawing from the study. A decision to leave the study can be taken at any time and will not affect the standard of care you receive. Withdrawing is a different process depending on the stage you are at in the study.

Withdrawal from randomised treatment
f you no longer wish to take part in the study e.g. because you have decided not to have the randomised treatment for any reason, your local research team will ask for your consent permission) to continue with your scheduled follow-ups and end-of-study evaluation. You will also still be given appropriate care under medical supervision until the symptoms of any adverse event resolve or your condition becomes stable. Follow-up will be continued through the study by Research Nurses, the lead investigator at each centre and, where these are unsuccessful, through the trial coordinating centre, unless you also withdraw consent for follow-up.

Complete Withdrawal from the study and further follow-up
If you withdraw from the treatment, as above, we will continue to collect data about your progress unless you also wish to withdraw from further follow-up. If you wish to withdraw from follow-up you should inform your local research team. You can do so at any time and you do not need to provide a reason why.
Information collected about you before the time at which you withdraw from the study will still be used in the study analyses, but no further information will be collected.

You can also choose to withdraw your consent for the information previously collected about you. The study team will keep your randomisation details and withdrawal form but all other information collected about you will be deleted/destroyed and not used in the study analysis. If you do not want any data previously collected about you to be used in the study, please talk to your local research team.

Withdrawing from routine data linkage
If you participated in NERVES and you did not choose to withdraw from the study at any time, then we will use routinely collected information about your outpatient, inpatient and A&E attendance during the study period.

We use your NHS number to “link” to your routinely collected information from NHS Digital.  The University of Liverpool will send your information (NHS number, date of birth, postcode) and your Trial ID (the number you were given as part of the study) to NHS Digital so that they can identify some routinely collected data, called “Health Episodes Statistics” (HES data). HES data is details of hospital admission(s), including inpatient, outpatient and emergency visits. NHS Digital will obtain your HES data from the beginning of the financial year in which the first patient was enrolled to the end of the financial year in which the final follow-up appointment for the last patient takes place. NHS Digital will remove the NHS number, date of birth and postcode but keep the Trial ID. NHS Digital will send your information from these records to The University of Liverpool via a secure link with only the Trial IDs included. The University of Liverpool will then share this data securely with Bangor University, who will undertake a Health Economic Analysis.

All data about you which is shared with Bangor University will be anonymised, which means that the people analysing the data will not be able to see your name or NHS number. If you would like to change your mind about this part of the study you are free to do so without giving a reason.

Please inform your local research team if you would like to withdraw from this data linkage.


Your local research team will be able to provide more information about the study and answer any questions you may have.

 




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