Radiofrequency Denervation and Brain Imaging

NCT05641948 | Recruiting

• 1 other identifier: 1-078-22
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain, Mechanical

Keywords

Neuroimaging; Radiofrequency denervation

Outcome Measures

Primary Outcomes (1)

• resting state functional connectivity of default mode network

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

  3 months after treatment

Study Arms (1)

Low Back Pain

In this prospective observational study, patients with chronic low back pain, scheduled for possible treatment with radiofrequency denervation (RFD), will be recruited from the NHS Grampian pain clinic. In the clinical pathway, patients will undergo a diagnostic medial branch nerve block (MBB). The outcome of this test determines if they are suitable for RFD. For this study, patients will be recruited from the clinics before the MBB. They will have both clinical assessments of pain levels and quality of life and a brain scan at three time intervals - baseline before the diagnostic nerve block, after diagnostic nerve block and 3 months after RFD. The final eligibility for the study is confirmed after the diagnostic block.

Other: MRI scan

Interventions

MRI scan OTHER

Participants will undergo brain MRI scan at 3 intervals

Low Back Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2 ZN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Saravanakumar NA Kanakarajan, Dr

CONTACT

01224 553237; Saravanakumar.kanakarajan@nhs.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: April 3, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

GB (1)