Evidence map›Paper›PMID 39067879›Full record

ArticleBMJ open2024

Effectiveness and cost-effectiveness of radiofrequency denervation versus placebo for chronic and moderate to severe low back pain: study protocol for the RADICAL randomised controlled trial.

Kate E Ashton, Cathy Price, Leah Fleming, Ashley W Blom, Lucy Culliford, Rebecca Nicole Evans, Nadine E Foster, William Hollingworth, Catherine Jameson, Nouf Jeynes and 6 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Kate E AshtonBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK kate.ashton@bristol.ac.uk.ORCID 0000-0002-9163-0512
Cathy PriceSolent NHS Trust, Southampton, UK.
Leah FlemingBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0001-5070-352X
Ashley W BlomFaculty of Health, The University of Sheffield, Sheffield, UK.
Lucy CullifordBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.
Rebecca Nicole EvansBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.
Nadine E FosterSTARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland, Saint Lucia, Queensland, Australia.
William HollingworthPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Catherine JamesonMusculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.
Nouf JeynesPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Andrew J MooreMusculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0003-3185-1599
Neil OrpenBMI Healthcare, The Ridgeway Hospital, Swindon, UK.
Cecily PalmerMusculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.
Barnaby C ReevesBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-5101-9487
Chris A RogersBristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-9624-2615
Vikki WyldeMusculoskeletal Research Unit, Bristol Medical School, University of Bristol, Bristol, UK.ORCID 0000-0002-8460-1529

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLow back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking. METHODS AND ANALYSIS: RADICAL (RADIofrequenCy denervAtion for Low back pain) is a double-blind, parallel-group, superiority randomised controlled trial. A total of 250 adults listed for RFD will be recruited from approximately 20 National Health Service (NHS) pain and spinal clinics. Recruitment processes will be optimised through qualitative research during a 12-month internal pilot phase. Participants will be randomised in theatre using a 1:1 allocation ratio to RFD or placebo. RFD technique will follow best practice guidelines developed for the trial. Placebo RFD will follow the same protocol, but the electrode tip temperature will not be raised. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered the alternative intervention to the one provided at the outset without disclosing the original allocation. The primary clinical outcome will be pain severity, measured using a pain Numeric Rating Scale, at 3 months after randomisation. Secondary outcomes will be assessed up to 2 years after randomisation and include disability, health-related quality of life, psychological distress, time to pain recovery, satisfaction, adverse events, work outcomes and healthcare utilisation. The primary statistical analyses will be by intention to treat and will follow a prespecified analysis plan. The primary economic evaluation will take an NHS and social services perspective and estimate the discounted cost per quality-adjusted life-year and incremental net benefit of RFD over the 2-year follow-up period. ETHICS AND DISSEMINATION: Ethics approval was obtained from the London-Fulham Research Ethics Committee (21/LO/0471). Results will be disseminated in open-access publications and plain language summaries. TRIAL REGISTRATION NUMBER: ISRCTN16473239.

Indexed as

Cost-Benefit AnalysisDenervationLow Back PainAdultChronic PainDouble-Blind MethodEquivalence Trials as TopicHumansNon-Randomized Controlled Trials as TopicPain MeasurementQuality of LifeTreatment OutcomeBack painChronic PainClinical TrialPain managementQuality of Life

Identifiers

PMID39067879
PMCPMC11284913

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.