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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.
Dr
Frances
Williams
frances.williams@kcl.ac.uk
Isabelle
GranvilleSmith
isabelle.smith@kcl.ac.uk
Other dorsopathies
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Low back pain is the leading cause of disability globally, caused largely by intervertebral disc degeneration. In some cases, disc degeneration may be caused by changes to the vertebra of the spine known as Modic change. Inflammatory Modic change (type 1) may be caused by bacteria from elsewhere in the body reaching the vertebral endplate leading to damage, inflammation and disc degeneration. We will collect surgical samples and compare bacterial DNA from removed discs that were adjacent to vertebra with type 1 Modic change (cases) to removed discs adjacent to vertebra without Modic change (controls). We will investigate bacterial DNA origins identified in the spine by collecting urine, saliva, faeces, skin swab and blood samples. The project aims to identify bacteria(-um) responsible for Modic type 1 change.
Patients undergoing spine surgery, discectomy or spine fusion are eligible and will be approached at surgical centres to discuss enrolling and consent. Consenting patients will be provided with stool collection kits and a researcher will collect saliva, urine, skin swabs and blood during routine preoperative appointments. Participants will also be asked to fill a questionnaire to ensure accurate interpretation of the bacterial results (questions regarding age, sex, body mass index, medication use, infection history, diet and stool information).
The project will run over 4 years. Years 1 and 2 will be allocated to patient recruitment and sample collection. Year 3 will see the samples being sent to the laboratories where they will be analysed for the bacterial genetic content using a process called 16S RNA gene analysis. Statistical testing will follow, along with writing up and dissemination during year 4.
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:
Observational type: Case-controlled study;
You can take part if:
You may not be able to take part if:
1.Pregnancy 2. Unable to give or reduced capacity to give informed consent 3. Type 1 or type 2 diabetes mellitus 4. Previous history of tuberculosis at any site within last year 5. Antibiotics given orally or IV within the previous 3 months 6. Taking oral corticosteroids for > 3 months in the year prior to surgery 7. Immunosuppression (immunosuppressant drugs (azathioprine, methotrexate, sulphasalazine etc; biologics, oral prednisone > 5mg), HIV, Hepatitis B or C) 8. Sickle cell disease 9. Malignancy requiring systemic treatment in the last 12 months 10. Previous radiotherapy to the region of interest 11. Previous lumbar spine surgery
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by King's College London and funded by VERSUS ARTHRITIS .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 45138
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
