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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.
Mr
Samuel
Wesley
Samuel.Wesley@gstt.nhs.uk
Dr
Adnan
Al - Kaisy
adnan.al-kaisy@gstt.nhs.uk
Other dorsopathies
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.
This is a clinical trial that serves to determine if stimulating the spinal cord at 10kHz using an implanted electrode can be effective in helping patients with long term low back pain. These patients have to have a component of their pain being nerve related and not as a result of previous spinal surgery. As conventional spinal cord stimulation at much lower frequencies (40-70Hz) is accepted for treating leg pain, usually as a result of previous spinal surgery it has poor effect on the pain that is coming from the back itself. We did some preliminary studies on using 10kHz spinal cord stimulation for low back pain without prior surgery and found very promising results that we wish to test using a more robust and controlled study design.
The study involves selecting patients with predominant low back pain with a neurophatic nerve component but no previous spinal surgery. All patients will be implanted with the device and for the duration of the study (6 months) they will be randomized to receive either active or dummy (placebo) treatment. One half of patients will have the spinal electrode activated and the other half will have a dummy electrode activated. After the study period all will be given the option of having the spinal electrode activated if it was not done so before. We aim to measure pain response and effects these devices will have on function, quality of life and medication use. In addition, we will look at any issues regarding safety and adverse effects.
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:
Interventional type: Device;Surgery;
You can take part if:
You may not be able to take part if:
• Had previous spinal surgery. • Chronic widespread pain. • Subject has an active implanted device, whether turned on or off (e.g. pacemaker, intrathecal pump, deep brain stimulator etc.). • A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumour, or severe/critical central or foraminal spinal stenosis. • Mechanical spine instability detected by a clinician (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by >5 degrees segmental angular movement) e.g. any forms of spondylolisthesis. • A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator. • Bleeding diathesis such as coagulopathy or thrombocytopenia. • Immunocompromised and at an increased risk for infection. • Systemic infection or local infection that would contraindicate SCS placement. • Metastatic malignant disease or active local malignant disease. • Pregnant (if female and sexually active, subject must be using a reliable form of contraception, be surgically sterile or be at least 2 years post-menopausal). • Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication. • Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator. • Concomitant participation in another clinical trial (surgery, device or drug).
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 GUY'S AND ST THOMAS' NHS FOUNDATION TRUST and funded by NIHR Central Commissioning Facility (CCF) .
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 37596
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
