Actively Recruiting

Age: 18Years +
All Genders
ID05641948

Radiofrequency Denervation and Brain Structure, Function, and Connectivity in Chronic Low Back Pain Patients

Led by University of Aberdeen · Updated on 2024-12-24

40

Participants Needed

1

Research Sites

21 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

Researchers are investigating changes in brain structure and activity following radiofrequency denervation (RFD) treatment for chronic low back pain (cLBP). This observational study focuses on patients with moderate to severe nociceptive low back pain and aims to report the extent of brain changes after RFD, identify changes unique to this treatment, and improve understanding of how RFD affects the brain. The findings could help predict which patients may benefit most from RFD and support future pain treatment studies. Participants will undergo three brain MRI scans at different times: before the diagnostic nerve block (baseline), after the diagnostic medial branch nerve block (MBB), and three months after receiving RFD. The study follows patients through their usual clinical pathway, starting with the MBB to determine suitability for RFD. Alongside imaging, patients will complete questionnaires about their pain, disability, and quality of life. During the study, participants will have clinical assessments and brain scans at each of the three time points to monitor changes over time. Researchers will measure resting state functional connectivity of the default mode network three months after treatment as the primary outcome. The study involves monitoring pain levels and health-related quality of life to better understand the effects of RFD. Participation includes informed consent and requires patients to be stable on current pain medications and able to communicate in English.

CONDITIONS

Brief 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 lasting at least 1 year
  • Identified by clinical team as suitable for radiofrequency denervation pathway
  • Predominantly nociceptive pain with PainDetect score of 12 or less
  • Stable on current pain medication regimen
  • Able to communicate in English
  • Capacity and willingness to give informed consent
  • Positive response to a single diagnostic medial branch nerve block with 80% or more pain relief at 3 hours after injection
Not Eligible

You will not qualify if you...

  • Physical condition preventing lying still for the duration of a brain MRI scan
  • Contraindications to MRI such as implantable cardiac devices
  • Women who are or may be pregnant
  • Significant anxiety or depression with a HADS score of 9 or higher
  • Clinical suspicion of alternative diagnosis causing low back pain
  • Presence of chronic primary pain conditions such as fibromyalgia or complex regional pain syndrome
  • Presence of thoracic or neck pain
  • History of previous radiofrequency denervation
  • Regular use of two or more dependence-forming drugs including opioids, gabapentinoids, benzodiazepines, tricyclic antidepressants, or z-drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo a diagnostic medial branch nerve block and a brain MRI scan to assess suitability for radiofrequency denervation treatment.

1 visit for nerve block and MRI scan

Long-term Monitoring

Duration - 3 months

Participants have follow-up brain MRI scans to observe brain structure and function changes after radiofrequency denervation treatment.

2 brain MRI scans (one after nerve block and one 3 months after treatment)

Trial Site Locations

Total: 1 location

1

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom, AB25 2 ZN

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Research Team

S

Saravanakumar NA Kanakarajan, Dr

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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