Radiofrequency denervation for low back pai

Not Applicable

• Conditions: Chronic and moderate to severe low back pain; Musculoskeletal Diseases; Low back pain

• Registration Number: ISRCTN16473239
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39067879/ (added 29/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-09
• Last Update Posted: 2 September 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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