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19/131 Short-term use of benzodiazepines for the acute management of acute 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:

What is the clinical and cost-effectiveness of short-term benzodiazepines for the acute management of acute low back pain?

  1. Intervention: Short-term benzodiazepines in addition to usual care.
    (Only those benzodiazepines should be studied that are available for use in the NHS. Applicants should specify dosage and treatment regimen, and define ‘usual care.’ Only one prescription should be issued, not exceeding 3-5 days in length.) 
  2. Patient group: Adults with acute low back pain with suspected muscle spasm, in whom the use of benzodiazepines is considered as a muscle-relaxant. Applicants should define and justify eligible patient groups.
  3. Setting: Any community and similarly appropriate settings. 
  4. Control: Usual care (without benzodiazepines). Applicants to consider and describe how variability of 'usual care' will be recorded and managed, and whether a placebo-controlled design is justified.
  5. Study design: A pragmatic 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.
  6. Important outcomes: Short-term changes in function and pain severity, using validated assessment tools.
    Other outcomes: Time to recovery; time to return to normal function and/or employment; days lost from work; adverse events; cost-effectiveness.
  7. Short-term follow-up: One week. 
    Longer-term follow up: Researchers should build in provision for a simple and efficient mechanism for longer-term follow up of one year duration that includes the use of routine data to assess future prescribing. 

Rationale:

Low back pain (LBP) is a very common problem that is often difficult to manage and that is associated with high usage of healthcare resources. It is a major cause of physical, psychological and social disability, although most back pain is self-limiting. Numerous pharmacological and non-pharmacological treatments are available for LBP, including benzodiazepines (e.g. diazepam). Guidelines from many countries recommend their short-term use in people with LBP when the paraspinal muscles are in spasm. However, the evidence for this mainly comes from studies on medications that are not licensed for this use in the UK.

The recently updated NICE guideline on the management of low back pain (NG59) no longer contains any treatment recommendation related to the use of benzodiazepines. While there is low quality and anecdotal evidence of potential benefit, benzodiazepines are not without risk of harm, even in short-term use.

Because of this, the NICE Guideline Development Group concluded that there is a need to investigate whether short-term treatment with diazepam is clinically and cost-effective in the acute management of acute low back pain.

A randomised controlled trial is required to answer this question and to inform future clinical practice.

NOTE TO APPLICANTS: This is a research area where strong PPI input is required.  

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 29th January 2020. Applications will be considered by the HTA Funding Committee at its meeting in March 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 July 2020.

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

Should you have any queries please contact us:

Email:   
htagb@nihr.ac.uk 

Telephone:  
General Funding Committee 02380 595630