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19/129 Lumbar fusion for low back pain

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question:

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

  1. Intervention:  Lumbar fusion – to be defined and justified by applicants.
  2. 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.
  3. Setting:  Secondary care.
  4. Comparator: Continued conservative management – to be defined and justified by applicants. Applicants to consider and justify whether or not a placebo procedure is required.
  5. Study design: 
    • A feasibility study (only if a placebo procedure is proposed) to explore the acceptability of the trial to patients and clinicians, and to assess the ability of the procedure to act as a placebo.
    • A randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. 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.
  6. Important outcomes:  Physical functioning; pain; health related quality of life.
    Other outcomes: Adverse events; mental health outcomes; occupational outcomes; analgesia use; cost-effectiveness.
  7. 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 conservative management (e.g. pain relief medication, physiotherapy, cognitive behavioural therapy), 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 conservative management for low back pain.

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 1st April 2020. Applications will be considered by the HTA Funding Committee at its meeting in May 2020.

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 September 2020.

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

Should you have any queries please contact us:

Email:   
htacommissioning@nihr.ac.uk 

Telephone:  
Commissioning Funding Committee 02380 595510