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| Name | Class |
|---|---|
| NHS Grampian | OTHER_GOV |
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The goal of this observational study is to learn about changes in brain and its activity of following radiofrequency denervation treatment for chronic low back pain. The main question it aims to answer are:
Patients with nociceptive type low back pain of moderate to severe intensity will be identified to undergo radiofrequency treatment. They will have 3 MRI scans - Baseline, after the diagnostic injections and 3 months after radiofrequency treatment. They will also fill questions relating to their pain, disability and health related quality of life.
Low back pain is one of the most common pain conditions and is the leading cause of years lived with disability. The management is challenging due to the heterogeneity of clinical presentation and includes self-management, pain killers, targeted injections as well as pain management programs. Brain MRI scans have identified networks of brain regions and changes in their activity in chronic low back pain (cLBP) patients. The scans have also been used to explore treatment-induced changes in brain and its activity. Radiofrequency denervation (RFD) of medial branch nerves is a NICE recommended treatment for a sub-group of cLBP sufferers. There are inter-individual variations in the response to RFD, which have been difficult to predict. The brain MRI scans can be used to better understand the effects of RFD on brain structure and function, and to predict those most likely to benefit from the interventions. So, we propose pilot study to investigate brain regions, their patterns and change after RFD treatment in this subgroup of cLBP sufferers. Eligible patients will have 3 brain MRI scans at various time intervals - Baseline, after nerve block and after RFD.
These brain scans will be analysed to provide the foundations for new studies such as improved selection of patients most likely to benefit from the treatment; improved understanding of mechanisms of the RFD treatment; and develop objective measurements that could be used in future trials of pain treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Back Pain | In this prospective observational study, patients with chronic low back pain, scheduled for possible treatment with radiofrequency denervation (RFD), will be recruited from the NHS Grampian pain clinic. In the clinical pathway, patients will undergo a diagnostic medial branch nerve block (MBB). The outcome of this test determines if they are suitable for RFD. For this study, patients will be recruited from the clinics before the MBB. They will have both clinical assessments of pain levels and quality of life and a brain scan at three time intervals - baseline before the diagnostic nerve block, after diagnostic nerve block and 3 months after RFD. The final eligibility for the study is confirmed after the diagnostic block. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI scan | Other | Participants will undergo brain MRI scan at 3 intervals |
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| Measure | Description | Time Frame |
|---|---|---|
| resting state functional connectivity of default mode network | Any difference between baseline and after successful treatment will be reported as primary outcome measure. | 3 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients of either sex, who have been referred for consideration of RF denervation or already found suitable for RF denervation pathway will be eligible for the study. The eligible participant should have nociceptive type, moderate to severe low back pain arising from lumbar facet joints.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saravanakumar NA Kanakarajan, Dr | Contact | 01224 553237 | Saravanakumar.kanakarajan@nhs.scot |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | Scotland | AB25 2 ZN | United Kingdom |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |