Actively Recruiting
Radiofrequency Denervation and Brain Changes in Chronic Low Back Pain An Observational Study of Brain Structure, Function, and Connectivity
Led by University of Aberdeen · Updated on 2024-12-24
40
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
U
University of Aberdeen
Lead Sponsor
N
NHS Grampian
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating changes in brain structure and activity following radiofrequency denervation treatment for chronic low back pain (cLBP). This observational pilot study focuses on patients with moderate to severe nociceptive low back pain who are suitable for this treatment. The goal is to measure the extent of brain changes after treatment and to identify changes specific to radiofrequency denervation, improving understanding of its effects and potentially guiding future patient selection. Participants will receive radiofrequency denervation of medial branch nerves as part of their treatment. They will undergo three brain MRI scans: one at baseline before treatment, one after diagnostic nerve block injections, and another three months following the radiofrequency treatment. These scans will help observe changes in brain structure, function, and connectivity over time in this patient subgroup. During the study, participants will also complete questionnaires about their pain, disability, and quality of life. Researchers will analyze MRI results and patient-reported outcomes to assess brain network activity, particularly the default mode network, three months after treatment. The study includes safety and monitoring to ensure participants can lie still for brain scans and remain stable on their pain medications throughout. Total participation covers the period from baseline through the three-month post-treatment scan.
CONDITIONS
Official Title
Radiofrequency Denervation and Brain Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic moderate to severe chronic low back pain with average pain intensity of 4 or higher on an 11-point scale for at least 1 year
- Identified by clinical team as suitable for radiofrequency denervation
- Predominantly nociceptive pain with PainDetect score 12 or less
- Stable on current pain medication regimen
- Able to communicate in English
- Able and willing to provide informed consent
- Positive response to a single diagnostic medial branch block with 80% or more pain relief at 3 hours post-injection
You will not qualify if you...
- Physical condition preventing lying still for the brain scan
- Contraindications to MRI such as implantable cardiac devices
- Women who are or may be pregnant
- Significant anxiety or depression (HADS score 9 or higher)
- Clinical suspicion of an alternative diagnosis causing low back pain
- Presence of chronic primary pain conditions (e.g., fibromyalgia, chronic widespread pain, complex regional pain syndrome, chronic primary headache, orofacial pain, chronic primary visceral pain, chronic primary musculoskeletal pain)
- Presence of thoracic or neck pain
- History of previous radiofrequency denervation
- Regular use of two or more dependence-forming drugs (opioids, gabapentinoids, benzodiazepines, tricyclic antidepressants, or z-drugs)
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Trial Site Locations
Total: 1 location
1
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2 ZN
Actively Recruiting
Research Team
S
Saravanakumar NA Kanakarajan, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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