NCT05641948

Radiofrequency Denervation and Brain Imaging

Radiofrequency Denervation and Brain Structure, Function And Connectivity In Chronic Low Back Pain Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of Aberdeen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * report the magnitude of the brain changes following radiofrequency treatment for low back pain. * identify changes unique to radiofrequency treatment 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.

Detailed description

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.

Conditions

• Low Back Pain, Mechanical

Interventions

Type	Name	Description
OTHER	MRI scan	Participants will undergo brain MRI scan at 3 intervals

Timeline

• Start date: 2023-04-03
• Primary completion: 2026-04-30
• Completion: 2026-09-30
• First posted: 2022-12-08
• Last updated: 2024-12-24

Locations

1 site across 1 country: United Kingdom