Chronic and moderate to severe low back pain Musculoskeletal Diseases Low back pain
Conditions
Interventions
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 par
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactKate Ashton
Outcome results
None listed