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21/18 Lumbar fusion for low back pain commissioning brief

 

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.

Research question

For people with low back pain, is lumbar fusion more effective than best conservative management?

  • Intervention: Lumbar fusion – to be defined and justified by applicants.
  • Patient group: Patients with low back pain for whom clinicians are considering treatment with lumbar fusion – to be defined and justified by applicants.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. 
  • Setting: Secondary care.
  • Comparator: Best conservative management – to be defined and justified by applicants.
  • Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
    Data should be submitted to the British Spine Registry or other appropriate long-term data repository. 
  • Important outcomes: Physical functioning; pain; health related quality of life.
  • Other outcomes: Adverse events; mental health outcomes; occupational outcomes; analgesia use; cost-effectiveness.
    Where established Core Outcomes exist they should be included amongst the list of outcomes unless there is good reason to do otherwise. 
  • Minimum duration of follow-up: 2 years.
  • Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Low back pain is soreness or stiffness in the back between the bottom of the rib cage and the top of the legs. Most people’s low back pain is described as “non-specific”, defined by NICE (NG59) as back pain that is unlikely to be caused by an infection, fracture or disease (including cancer). Low back pain can be a debilitating condition, affecting quality of life and ability to work. It is a leading cause of disability with major socioeconomic consequences and high NHS resource use.

One treatment used for low back pain, after an inadequate response to a conservative approach (e.g. pain relief medication, physiotherapy), is lumbar fusion. This involves an operation to fuse vertebrae together with a bone graft in order to achieve a solid union of bone. There are various techniques used to perform this operation each with benefits and associated risks. Although lumbar fusion is routinely used in practice, there is great uncertainty about its effectiveness. Various studies have investigated the effectiveness of lumbar fusion, and although there are mixed results, these studies often find lumbar fusion gives moderate benefits with regards to pain relief but fail to demonstrate clear benefits overall when compared to conservative management.

The NICE guideline on low back pain and sciatica does not recommend the use of lumbar fusion for low back pain unless as part of a randomised controlled trial. However, two NICE interventional procedure guidelines state that lumbar fusion is safe and effective for low back pain specifically for degenerative indications.

Due to the high degree of uncertainty regarding the effectiveness of lumbar fusion, and in response to a NICE guideline research recommendation, the HTA programme wishes to commission a trial to determine the effectiveness of lumbar fusion compared to best conservative management for low back pain. A placebo arm is not expected as part of any application.

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 28 July 2021. Applications will be considered by the HTA Funding Committee at its meeting in September 2021.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

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 January 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 at htacommissioning@nihr.ac.uk.