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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.
Ms
Kate
Ashton
Dr
Vikki
Wylde
Chronic and moderate to severe low back pain
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Long-term low back pain is common, affecting 10-15% of adults. It can significantly impair the health, mood, and daily lives of people who have it. One type of low back pain is caused by the small joints between the bones in the lower back. Treatments include painkillers, exercise and talking therapies. However, if people do not get better with these treatments, they can be offered radiofrequency “denervation”. Denervation involves placing a needle in the nerve to the painful joint, which is heated up to cause a break in the nerve. The purpose of this is to stop the nerve from sending pain messages to the brain. Denervation is low risk and is used widely in the National Health Service (NHS) but it is not known if this procedure definitely reduces pain or is a good way to spend NHS money. This study aims to find out if denervation reduces low back pain and is good value for money.
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:
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39067879/ (added 29/07/2024)
You can take part if:
Current inclusion criteria as of 22/05/2023:
1. 18 years of age or older
2. LBP is the primary source of pain
3. Positive response to a single diagnostic MBB with no steroids administered
4. Chronic LBP (>3 months duration), assumed due to the fact patient was listed for MBB
5. Moderate to severe LBP (pain NRS score ≥5 on Baseline Questionnaire)
6. Listed for RFD by their cl
You may not be able to take part if:
Current exclusion criteria as of 22/05/2023:1. Known pregnancy2. Severe depression (Hospital Anxiety and Depression Scale (HADS) depression score >= 15)3. Known previous RFD4. Known previous back surgery where metal-work has been used in the lumbar spine5. Pacemaker or implantable cardioverter-defibrillator6. Clinical suspicion that an alternative diagnosis is the reason for low back pain (as defined by NICE, including, but not limited to: metastatic spinal cord compression, spinal injury, spondyloarthritis, or cancer)7. Prisoner8. Patient lacks capacity to consent9. Existing co-enrolment in another clinical study if: i) the intervention in the other study is expected to influence the primary outcome (this will be considered by a senior clinician on a case-by-case basis); ii) it is considered too burdensome for the patient; or iii) it is not permitted by the other study
Previous exclusion criteria:1. Known pregnancy 2. Unwilling or unable to tolerate procedure 3. Severe depression (Hospital Anxiety and Depression Scale (HADS) depression score >= 15) 4. Known previous RFD 5. Known previous back surgery where metal-work has been used in the lumbar spine6. Pacemaker or implantable cardioverter-defibrillator7. Clinical suspicion that an alternative diagnosis is the reason for low back pain (as defined by NICE, including, but not limited to: metastatic spinal cord compression, spinal injury, spondyloarthritis, or cancer)8. Prisoner9. Patient lacks capacity to consent10. Existing co-enrolment in another clinical study if: i) the intervention in the other study is expected to influence the primary outcome (this will be considered by a senior clinician on a case-by-case basis); ii) it is considered too burdensome for the patient; or iii) it is not permitted by the other study
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Vikki
Wylde
Ms
Kate
Ashton
The study is sponsored by North Bristol NHS Trust and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR127457.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 46543
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
