Actively Recruiting

Age: 18Years +
All Genders
NCT05641948

Radiofrequency Denervation and Brain Imaging

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

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

Official Title

Radiofrequency Denervation and Brain Imaging

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom, AB25 2 ZN

Actively Recruiting

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Research Team

S

Saravanakumar NA Kanakarajan, Dr

CONTACT

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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