Radiofrequency Denervation and Brain Imaging

Sponsor
University of Aberdeen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05641948
Collaborator
NHS Grampian (Other)
40
1
35
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI scan

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Radiofrequency Denervation and Brain Structure, Function And Connectivity In Chronic Low Back Pain Patients
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Low Back Pain

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

Outcome Measures

Primary Outcome Measures

  1. resting state functional connectivity of default mode network [3 months after treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aberdeen Royal Infirmary Aberdeen Scotland United Kingdom AB25 2 ZN

Sponsors and Collaborators

  • University of Aberdeen
  • NHS Grampian

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT05641948
Other Study ID Numbers:
  • 1-078-22
First Posted:
Dec 8, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aberdeen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2022