Radiofrequency denervation for low back pain
| ISRCTN | ISRCTN16473239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16473239 |
| IRAS number | 285322 |
| Secondary identifying numbers | CPMS 46543, IRAS 285322, NIHR127457 |
- Submission date
- 17/08/2021
- Registration date
- 09/11/2021
- Last edited
- 30/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Long-term low back pain is common, affecting 10-15% of adults. It can significantly impair the health, mood, and daily lives of people who have it. One type of low back pain is caused by the small joints between the bones in the lower back. Treatments include painkillers, exercise and talking therapies. However, if people do not get better with these treatments, they can be offered radiofrequency “denervation”. Denervation involves placing a needle in the nerve to the painful joint, which is heated up to cause a break in the nerve. The purpose of this is to stop the nerve from sending pain messages to the brain. Denervation is low risk and is used widely in the National Health Service (NHS) but it is not known if this procedure definitely reduces pain or is a good way to spend NHS money. This study aims to find out if denervation reduces low back pain and is good value for money.
Who can participate?
Patients aged 18 years or older with chronic moderate to severe low back pain who are eligible for radiofrequency denervation treatment
What does the study involve?
Participants are randomly allocated into one of two groups. Half will have the denervation and half will have a placebo treatment, which involves placement of the needle in the nerve but without heating it up so the nerve is not affected. Participants whose symptoms do not improve after 3 months will be offered the chance to receive the other treatment. This means that patients who had no improvement because they had the placebo treatment first would have the opportunity for denervation the second time. Participants will be asked questions about their low back pain, ability to carry out daily tasks including their work, their general health, and mental well-being over the next 2 years. Information will also be collected to find out if denervation is good value for money.
What are the possible benefits and risks of participating?
There are no guaranteed benefits of participating, but the results from this study may help improve the treatment of people with low back pain in the future. The risks associated with taking part in this study are the same as the risks of having this procedure as part of usual care, and are the same for both the denervation and the placebo treatment. However, if participants do not experience an improvement in pain after 3 months, they will be offered the chance to receive the other treatment. Therefore, there is the possibility that participants will have two procedures (denervation and placebo treatment). The procedure is low risk and serious side effects are rare.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
August 2018 to September 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Vikki Wylde (Chief Investigator) or Kate Ashton (Trial Manager)
radical-study@bristol.ac.uk
Contact information
Public
Bristol Trials Centre
Bristol Medical School
University of Bristol
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
 ORCID ID |
0000-0002-9163-0512 |
|---|
Scientific
Musculoskeletal Research Unit
Translational Health Sciences
Bristol Medical School
University of Bristol
Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| ORCID ID |
0000-0002-8460-1529 |
|---|
Study information
| Study design | Randomized; Both; Design type: Treatment, Other, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Radiofrequency denervation for chronic and moderate to severe low back pain (RADICAL) |
| Study acronym | RADICAL |
| Study hypothesis | Radiofrequency denervation compared to a placebo treatment reduces the severity of pain at 3 months after the intervention. |
| Ethics approval(s) | Approved 30/07/2021, London - Fulham Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8035; fulham.rec@hra.nhs.uk), REC ref: 21/LO/0471 |
| Condition | Chronic and moderate to severe low back pain |
| Intervention | Trial participants will be randomised in a 1:1 ratio to receive either radiofrequency denervation (RFD) of the lumbar medial branches of the dorsal rami; or placebo treatment, which will follow the same protocol, but the electrode tip temperature will not be raised. Randomisation will be performed by a member of the theatre staff, not involved in participant follow-up, via a secure internet-based randomisation system ensuring allocation concealment. Participants will be allocated in a 1:1 ratio to RFD or placebo treatment. The allocation, prepared by a statistician independent of the trial team, will be computer-generated and blocked with varying block sizes. Randomisation will be stratified by operator to ensure that any operator effect is distributed equally across groups. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered “repeat RFD” but with the alternative intervention to the one provided at the outset without disclosing the original allocation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Patient-reported low back pain (LBP) pain severity over the past week, measured using a 0-10 pain Numeric Rating Scale (NRS); Timepoint(s): 3 months post-randomisation |
| Secondary outcome measures | 1. Functional disability measured using the Oswestry Disability Index (ODI) version 2.1b at baseline, 3, 6, 12, 18 and 24 months post randomisation 2. Health-related quality of life (HRQoL) measured using EQ-5D-5L at baseline, 6 weeks, and 3, 6, 12, 18 and 24 months post randomisation 3. General health measured using SF-12 Physical Component Score at baseline, 3, 6, 12, 18 and 24 months post randomisation 4. Mental health measured using SF-12 Mental Component Score at baseline, 3, 6, 12, 18 and 24 months post randomisation 5. Time to pain recovery measured using time from randomisation until the first timepoint at which the patient reports a pain reduction of ≥60% that remains at ≥60% lower than baseline at their subsequent timepoint. Pain severity over the past week will be measured using a 0-10 pain Numerical Rating Scale (NRS), administered at baseline, 2, 4, 6, 8 and 10 weeks, and 3, 6, 12, 18 and 24 months post randomisation. Updated 08/07/2024: Pain severity over the past week will be measured using a 0-10 pain Numerical Rating Scale (NRS), administered at baseline, 2 and 6 weeks, and 3, 6, 12, 18 and 24 months post randomisation 6. Uptake of offer for repeat RFD. This will be offered to participants who are eligible 3 months after randomisation and can be taken up by participants up to 24 months 7. Satisfaction with treatment outcome measured using Likert scale at 3, 6, 12, 18 and 24 months post randomisation 8. Adverse events measured using active capture of adverse events at 2 and 6 weeks, and 3, 6, 12, 18 and 24 months post randomisation 9. Work outcomes: Work status and days lost from work and usual activities due to LBP measured using the Work Productivity and Activity Impairment (WPAI) questionnaire at baseline, 3, 6, 12, 18 and 24 months post randomisation 10. Healthcare utilisation, including medications, measured using a patient-reported resource use questionnaire at baseline, 3, 6, 12, 18 and 24 months post randomisation, and medical records |
| Overall study start date | 22/08/2018 |
| Overall study end date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Participant inclusion criteria | Current inclusion criteria as of 22/05/2023: 1. 18 years of age or older 2. LBP is the primary source of pain 3. Positive response to a single diagnostic MBB with no steroids administered 4. Chronic LBP (>3 months duration), assumed due to the fact patient was listed for MBB 5. Moderate to severe LBP (pain NRS score ≥5 on Baseline Questionnaire) 6. Listed for RFD by their clinical care team Previous inclusion criteria: 1. 18 years of age or older 2. Chronic moderate to severe LBP (>3 months duration, pain NRS score ≥5 for usual pain over the past week at the time of screening) 3. LBP is the primary source of pain 4. Referred to a pain or spinal clinic 5. Listed for MBB by their clinical care team (due to clinical suspicion or clinical features suggesting that the main source of LBP is from a facet joint) 6. Positive response to a single diagnostic MBB with 1 ml or less of local anaesthetic at each level (no steroids) 7. Listed for RFD by their clinical care team |
| Participant exclusion criteria | Current exclusion criteria as of 22/05/2023: 1. Known pregnancy 2. Severe depression (Hospital Anxiety and Depression Scale (HADS) depression score >= 15) 3. Known previous RFD 4. Known previous back surgery where metal-work has been used in the lumbar spine 5. Pacemaker or implantable cardioverter-defibrillator 6. Clinical suspicion that an alternative diagnosis is the reason for low back pain (as defined by NICE, including, but not limited to: metastatic spinal cord compression, spinal injury, spondyloarthritis, or cancer) 7. Prisoner 8. Patient lacks capacity to consent 9. Existing co-enrolment in another clinical study if: i) the intervention in the other study is expected to influence the primary outcome (this will be considered by a senior clinician on a case-by-case basis); ii) it is considered too burdensome for the patient; or iii) it is not permitted by the other study Previous exclusion criteria: 1. Known pregnancy 2. Unwilling or unable to tolerate procedure 3. Severe depression (Hospital Anxiety and Depression Scale (HADS) depression score >= 15) 4. Known previous RFD 5. Known previous back surgery where metal-work has been used in the lumbar spine 6. Pacemaker or implantable cardioverter-defibrillator 7. Clinical suspicion that an alternative diagnosis is the reason for low back pain (as defined by NICE, including, but not limited to: metastatic spinal cord compression, spinal injury, spondyloarthritis, or cancer) 8. Prisoner 9. Patient lacks capacity to consent 10. Existing co-enrolment in another clinical study if: i) the intervention in the other study is expected to influence the primary outcome (this will be considered by a senior clinician on a case-by-case basis); ii) it is considered too burdensome for the patient; or iii) it is not permitted by the other study |
| Recruitment start date | 16/03/2022 |
| Recruitment end date | 31/07/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Leeds
LS9 7TF
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Sutton-In-Ashfield
NG17 4JL
United Kingdom
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Coventry
CV2 2DX
United Kingdom
London
E1 2ES
United Kingdom
Liverpool
L9 7LJ
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Reading
RG1 5AN
United Kingdom
Birmingham
B18 7QH
United Kingdom
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Mansfield Road
Sutton-in-ashfield
NG17 4JL
United Kingdom
Magdala Avenue
London
N19 5NF
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)117 414 9330 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | https://www.nbt.nhs.uk/research-innovation |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers will be publishing the protocol in a peer-reviewed journal. It will also be available on the HTA website, once it has been fully approved by the HRA. The findings will be disseminated by usual academic channels, i.e. presentation at international meetings, as well as by peer-reviewed publications (including a full report to the NIHR Health Technology Assessment (HTA) programme) and through patient organisations and newsletters to patients, where available. |
| IPD sharing plan | Data will not be made available for sharing until after the publication of the main results of the study. Thereafter, anonymised individual patient data will be made available for secondary research, conditional on assurance from the secondary researcher that the proposed use of the data is compliant with the MRC Policy on Data Sharing regarding scientific quality, ethical requirements and value for money. A minimum requirement with respect to scientific quality will be a publicly available pre-specified protocol describing the purpose, methods and analysis of the secondary research, e.g. a protocol for a Cochrane systematic review. Anonymised recruitment consultation and interview transcripts may also be used to support the teaching of qualitative research methods. Please contact Vikki Wylde using the following email: radical-study@bristol.ac.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 27/07/2024 | 29/07/2024 | Yes | No |
Editorial Notes
30/12/2024: The following changes were made:
1. The recruitment end date was changed from 31/12/2024 to 31/07/2025.
2. The overall study end date was changed from 31/12/2024 to 30/09/2026.
17/10/2024: Internal review.
21/08/2024: The recruitment end date was changed from 31/08/2024 to 31/12/2024.
29/07/2024: Publication reference added.
08/07/2024: The secondary outcome measures were updated.
14/03/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2024 to 31/08/2024.
2. The overall study end date was changed from 31/05/2024 to 31/12/2024.
3. The intention to publish date was changed from 01/12/2024 to 31/12/2024.
4. The study participating centres were updated to remove Bradford Royal Infirmary, Royal Derby Hospital, Kingston Hospital NHS Foundation Trust and Sandwell and West Birmingham Hospitals NHS Trust and add Whittington Health NHS Trust, East Kent Hospitals University NHS Foundation Trust, the Royal Orthopaedic Hospital NHS Foundation Trust, and Solent NHS Trust.
18/07/2023: The recruitment end date was changed from 31/07/2023 to 31/01/2024.
22/05/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 15/05/2023 to 31/07/2023.
2. The inclusion and exclusion criteria and contact details were updated.
3. The study participant centres were updated to add Epsom and St Helier University Hospitals NHS Trust
Kingston Hospital NHS Foundation Trust, Liverpool Foundation NHS Trust, Royal Orthopaedic Hospital, Birmingham, Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Sandwell and West Birmingham Hospitals NHS Trust and Sherwood Forest Hospitals NHS Trust, and to remove Frimley Park Hospital, Queen Alexandra Hospital, Portsmouth, St Thomas’ Hospital, London, Royal National Orthopaedic Hospital, London, Royal Derby Hospital, Dorset Healthcare University NHS Foundation Trust
Basingstoke and North Hampshire Hospital, and Leicester Royal Infirmary.
22/03/2022: The recruitment start date was changed from 01/04/2022 to 16/03/2022.
15/03/2022: The recruitment start date was changed from 01/03/2022 to 01/04/2022.
16/02/2022: The recruitment start date was changed from 15/02/2022 to 01/03/2022.
13/01/2022: The recruitment start date was changed from 15/01/2022 to 15/02/2022.
13/12/2021: The recruitment start date was changed from 15/12/2021 to 15/01/2022.
16/11/2021: Internal review.
17/08/2021: Trial's existence confirmed by the NIHR.
