Radiofrequency Denervation and Brain Imaging

ConditionLow Back Pain, Mechanical

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Aberdeen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial population

Adult patients of either sex, who have been referred for consideration of RF denervation or already found suitable for RF denervation pathway will be eligible for the study. The eligible participant should have nociceptive type, moderate to severe low back pain arising from lumbar facet joints.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

MRI scan
Other intervention
Participants will undergo brain MRI scan at 3 intervals

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Low Back Pain1 intervention

Trial outcomes

Primary outcomes

resting state functional connectivity of default mode network

Any difference between baseline and after successful treatment will be reported as primary outcome measure.

Time frame

3 months after treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aberdeen

Lead sponsor

NHS Grampian

Collaborator

Source ClinicalTrials.gov

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