Investigating brain changes after radiofrequency treatment for low back pain
Radiofrequency Denervation and Brain Structure, Function And Connectivity In Chronic Low Back Pain Patients
This study is testing how radiofrequency treatment for chronic low back pain affects brain activity in patients to better understand its impact and improve future pain management.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aberdeen Academic / other |
| Locations | 1 site (Aberdeen, Scotland) |
| Trial ID | NCT05641948 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the changes in brain activity following radiofrequency denervation treatment for chronic low back pain. Patients with moderate to severe nociceptive low back pain will undergo three MRI scans at different intervals: baseline, after diagnostic injections, and three months post-treatment. The study seeks to identify unique brain changes associated with radiofrequency treatment and improve understanding of its effects on brain structure and function. By analyzing these brain scans, the research aims to enhance patient selection for this treatment and develop objective measures for future pain management trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic moderate to severe nociceptive low back pain who are suitable for the radiofrequency denervation pathway.
Not a fit: Patients with conditions that prevent them from lying still during MRI scans or those with contraindications to magnetic resonance imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better patient selection for radiofrequency denervation, improving treatment outcomes for chronic low back pain.
How similar studies have performed: While the approach of using neuroimaging to assess treatment effects is established, this specific investigation into radiofrequency denervation's impact on brain activity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aberdeen, Scotland
- Aberdeen Royal Infirmary — Aberdeen, Scotland, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Saravanakumar NA Kanakarajan, Dr
- Email: Saravanakumar.kanakarajan@nhs.scot
- Phone: 01224 553237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.