Evidence map›Paper›PMID 30064491›Full record

Trial reportTrials2018

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).

Nefyn H Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A Hughes, Eifiona Wood, Nadine E Foster, David Walsh, Dawn Carnes, Valerie Sparkes and 7 more

Open access · goldAbstract readMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 29% of its field
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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. 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

17 authors at 10 institutions in 3 countries.

Nefyn H WilliamsDepartment of Health Services Research, University of Liverpool, Waterhouse Block B, 1-5 Brownlow Street, Liverpool, L69 3GL, UK. nefyn.williams@liverpool.ac.uk.ORCID http://orcid.org/0000-0002-8078-409X
Alison JenkinsSchool of Healthcare Sciences, Bangor University, Bangor, UK.
Nia GouldenSchool of Healthcare Sciences, Bangor University, Bangor, UK.
Zoe HoareSchool of Healthcare Sciences, Bangor University, Bangor, UK.
Dyfrig A HughesSchool of Healthcare Sciences, Bangor University, Bangor, UK.
Eifiona WoodSchool of Healthcare Sciences, Bangor University, Bangor, UK.
Nadine E FosterArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
David WalshArthritis Research UK Pain Centre and National Institute for Health Research Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, UK.
Dawn CarnesCentre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry, London, UK.
Valerie SparkesSchool of Healthcare Science, Cardiff University, Cardiff, UK.
Elaine M HayArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
John IsaacsNational Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle upon Tyne, UK.
Kika KonstantinouArthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.
Dylan MorrisseyCentre for Sports and Exercise Medicine, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Jaro KarppinenMedical Research Centre Oulu, University of Oulu and Oulu University Hospital, Oulu, Finland.
Stephane GenevayUniversity Hospitals of Geneva, Geneva, Switzerland.
Clare WilkinsonSchool of Healthcare Sciences, Bangor University, Bangor, UK.
Bangor University · GBKeele University · GBBarts Health NHS Trust · GBCardiff University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBOulu University Hospital · FIQueen Mary University of London · GBUniversity Hospital of Geneva · CHUniversity of Liverpool · GBUniversity of Nottingham · GB

Funding

Department of Health CAT SCL-2013-04-003Department of Health HTA/12/201/02Health Technology Assessment Programme 12/201/02
6 · The paper itself

Abstract

backgroundAdalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.

methodsA pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.

resultsThe internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.

conclusionsImproved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.

trial registrationCurrent Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.

Indexed as

Early Termination of Clinical TrialsPhysical Therapy ModalitiesAdalimumabAnti-Inflammatory AgentsCombined Modality TherapyContractsDisability EvaluationHumansInjections, SubcutaneousPain MeasurementPatient SelectionResearch Support as TopicSciaticaTime FactorsTreatment OutcomeTumor Necrosis Factor-alphaAdalimumabAnti-Inflammatory AgentsTumor Necrosis Factor-alphaAdalimumabAnti-TNF-αBiological agentsEconomic evaluationFeasibilityRandomised controlled trialSciatica

Identifiers

PMID30064491
PMCPMC6069989
OpenAlexW2884356747

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.