Radiofrequency Denervation and Brain Imaging

Launched by UNIVERSITY OF ABERDEEN · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a specific treatment called radiofrequency denervation (RFD) affects the brain activity of people suffering from chronic low back pain. The researchers want to observe any changes in the brain after the treatment and see if these changes are unique to this type of therapy. Participants will be individuals aged 18 and older who have had moderate to severe low back pain for at least a year and have been identified as suitable for this treatment by their healthcare team.

If you choose to participate, you will undergo three MRI scans: one before the treatment, one after a diagnostic injection, and another three months after receiving the radiofrequency treatment. Additionally, you'll be asked some questions about your pain levels, daily activities, and overall health. This study is currently recruiting participants, but there are some criteria you need to meet to be eligible, such as having a specific type of pain and being stable on your current pain medication. It’s important to note that certain conditions or factors, like pregnancy or previous similar treatments, may exclude you from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older
• • Chronic moderate to severe cLBP (defined by average pain intensity of ≥ 4 in the 11 point Numerical Pain rating scale and a minimum duration of 1 year)
• • Identified by clinical team as suitable for RFD pathway
• • Predominantly nociceptive pain (as defined by PainDetect score ≤12)
• • Stable on current analgesic regime
• • Able to communicate in English
• • Has the capacity to and agrees to give informed consent for participation in the study
• • Positive response to a single diagnostic MBB with 1 ml or less of local anaesthetic (bupivacaine 0.5%) at each level. (a positive response is defined as ≥80% pain relief at 3 hours, based on patient reported assessment)
• Exclusion Criteria:
• • Any patient whose physical condition will preclude them from lying still for the duration of the brain scan.
• • Contraindication to magnetic resonance scanning such as an implantable cardiac device.
• • Women who are, or may be, pregnant. (Pregnant patients do not undergo pain procedures under radiological guidance as per routine clinical care)
• • Significant anxiety and depression (as defined by HADS score ≥ 9)
• • Clinical suspicion that alternative diagnosis is the reason for LBP
• • Presence of chronic primary pain conditions (Fibromyalgia, chronic widespread pain, Complex Regional Pain Syndrome, Chronic Primary Headache, Orofacial pain, Chronic primary visceral pian and Chronic Primary musculoskeletal pain as defined by ICD-11 classification)
• • Presence of thoracic or neck pain
• • History of previous RF denervation
• • Regular use of two or more dependence forming drugs (opioids, gabapentinoids, Benzodiazepines, tricyclics antidepressants and z-drugs)