Low Back Pain, MechanicalNCT05641948
Radiofrequency Denervation and Brain Imaging
An observational study of Low Back Pain, Mechanical, run by University of Aberdeen at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- MRI scan
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2 ZN
Saravana Kanakarajan, MD, 01224553237, saravanakumark@abdn.ac.uk
About this study
Official title: Radiofrequency Denervation and Brain Structure, Function And Connectivity In Chronic Low Back Pain Patients
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.
Read the detailed description
Low back pain is one of the most common pain conditions and is the leading cause of years lived with disability. The management is challenging due to the heterogeneity of clinical presentation and includes self-management, pain killers, targeted injections as well as pain management programs. Brain MRI scans have identified networks of brain regions and changes in their activity in chronic low back pain (cLBP) patients. The scans have also been used to explore treatment-induced changes in brain and its activity. Radiofrequency denervation (RFD) of medial branch nerves is a NICE recommended treatment for a sub-group of cLBP sufferers. There are inter-individual variations in the response to RFD, which have been difficult to predict. The brain MRI scans can be used to better understand the effects of RFD on brain structure and function, and to predict those most likely to benefit from the interventions. So, we propose pilot study to investigate brain regions, their patterns and change after RFD treatment in this subgroup of cLBP sufferers. Eligible patients will have 3 brain MRI scans at various time intervals - Baseline, after nerve block and after RFD.
These brain scans will be analysed to provide the foundations for new studies such as improved selection of patients most likely to benefit from the treatment; improved understanding of mechanisms of the RFD treatment; and develop objective measurements that could be used in future trials of pain treatments.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- MRI scan
- Keywords
- Neuroimaging, Radiofrequency denervation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanOther
Participants will undergo brain MRI scan at 3 intervals
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting state functional connectivity of default mode network
Any difference between baseline and after successful treatment will be reported as primary outcome measure.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start3 Apr 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641948
- Sponsor's protocol ID
- 1-078-22
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Denervation and Brain Structure, Function And Connectivity In Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT05641948
- Acronym / sponsor ID
- 1-078-22
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Neuroimaging, Radiofrequency denervation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low back pain is one of the most common pain conditions and is the leading cause of years lived with disability. The management is challenging due to the heterogeneity of clinical presentation and includes self-management, pain killers, targeted injections as well as pain management programs. Brain MRI scans have identified networks of brain regions and changes in their activity in chronic low back pain (cLBP) patients. The scans have also been used to explore treatment-induced changes in brain and its activity. Radiofrequency denervation (RFD) of medial branch nerves is a NICE recommended treatment for a sub-group of cLBP sufferers. There are inter-individual variations in the response to RFD, which have been difficult to predict. The brain MRI scans can be used to better understand the effects of RFD on brain structure and function, and to predict those most likely to benefit from the interventions. So, we propose pilot study to investigate brain regions, their patterns and change after RFD treatment in this subgroup of cLBP sufferers. Eligible patients will have 3 brain MRI scans at various time intervals - Baseline, after nerve block and after RFD.
These brain scans will be analysed to provide the foundations for new studies such as improved selection of patients most likely to benefit from the treatment; improved understanding of mechanisms of the RFD treatment; and develop objective measurements that could be used in future trials of pain treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain | – | Other: MRI scanIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanParticipants will undergo brain MRI scan at 3 intervals | Other | Low Back Pain |
Primary outcome
resting state functional connectivity of default mode network
Time frame: 3 months after treatment
Any difference between baseline and after successful treatment will be reported as primary outcome measure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, Mechanical, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saravanakumar NA Kanakarajan, Dr (01224 553237, Saravanakumar.kanakarajan@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting state functional connectivity of default mode network (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.