Radiofrequency Denervation and Brain Imaging

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641948
• Other study ID #: 1-078-22
• Status: Recruiting
• Start date: April 3, 2023
• Est. completion date: March 2026

Study information

• Verified date: June 2023
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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