Investigating brain changes after radiofrequency treatment for low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aberdeen Royal Infirmary
  Aberdeen, Scotland, United Kingdom Recruiting

Study contacts

• Study coordinator: Saravanakumar NA Kanakarajan, Dr
• Email: Saravanakumar.kanakarajan@nhs.scot
• Phone: 01224 553237

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.