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21/540 Pharmacological treatments for low back pain or sciatica

Contents

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

This is a brief of broader scope from which the HTA Programme is interested in funding research that generates answers to the multiple questions within this patient pathway. Studies should utilise the most appropriate and efficient designs to enable multiple research questions to be answered

We are interested in proposals for the evaluation of pharmacological treatments for low back pain and/or sciatica. Applicants should clearly define and justify their choice of intervention(s), patient group(s), study design, outcome measures and settings, and explain how the research will fit into the remit of the HTA Programme. Any randomised studies will be considered. Evidence syntheses, developmental or discovery studies are not included within the scope of this call.

Examples of topics of interest include, but are not limited to the research recommendations issued in NICE guideline Low back pain and sciatica in over 16s: assessment and management (NICE guideline [NG59] December 2020), addressing the clinical and cost effectiveness of:

  • opioids for the management of acute sciatica;
  • antidepressants for the management of sciatica;
  • benzodiazepines for the management of acute low back pain;
  • codeine with and without paracetamol for the management of acute low back pain.

Rationale

Low back pain and sciatica are very common problems that are often difficult to manage. They are associated with high usage of healthcare resources and loss of working days. Low back pain and sciatica are also major causes of physical, psychological and social disability.

Numerous pharmacological treatments have been explored. However, while there is low-quality and anecdotal evidence of potential benefit, some drugs, including those mentioned above, are not without risk of harm, even in short-term use. There is particular concern regarding the risk of dependence on, and difficulties withdrawing from, some prescribed medicines.

The Guideline Development Group responsible for NICE guideline NG59 has therefore recommended that research should be undertaken to investigate the effectiveness of pharmacological interventions for the treatment of low back pain and sciatica, with particular interest in research of the topics outlined above.

The HTA Programme wishes to fund this research to inform clinical practice, patient choice, and future guideline updates. We are looking at the evaluation of interventions that will make a step change in clinical treatment and patient pathways. Applicants should utilise the most appropriate and efficient study design for delivering the answers to the research questions. Designs that enable multiple questions to be answered simultaneously (e.g. platform trials, n-of-1) would be welcomed. Applicants may consider consulting a CTU that has experience in delivering efficient, innovative study designs. Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (or their advocates) in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR learning for involvement guidance on co-producing a research project.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 1 December 2021. Applications will be considered by the HTA Funding Committee at its meeting in January 2022.

Guidance notes and supporting information for HTA Programme applications are available.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition. For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk