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
What is the clinical and cost-effectiveness of botulinum toxin in the management of chronic masticatory myofascial pain?
- Intervention: Botulinum toxin injection(s) (Applicants should specify and justify treatment regimens).
- Patient group: Adults with chronic masticatory myofascial pain, in whom usual care has failed (Applicants to specify and justify).
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:Any suitable NHS setting.
- Control: To be specified and justified by applicants. Applicants to consider and justify whether or not a placebo procedure is required.
- 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. Applicants should utilise the most appropriate and efficient study design for delivering the answer to the research question.
- Important outcomes: Pain (measured by use of validated tools).
- Other outcomes: Health- and disease-related quality of life; use of analgesics; sleep and diet scores; maximum interincisal distance; adverse effects; cost-effectiveness. Subgroup analyses should be considered if appropriate. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).
- Minimum duration of follow-up: An appropriate duration from randomisation or start of treatment (Applicants to specify and justify).
- 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
Masticatory myofascial pain describes musculoskeletal conditions that affect the masticatory muscles, i.e. the muscles associated with the movements of the jaw and its surrounding structures. The pain may radiate around the ear to the cheek, temple, teeth and jaw angle, and can impact quality of life.
Masticatory myofascial pain is one of the common causes of orofacial pain. The condition is often self-limiting, however, a significant proportion of patients experience persistent, chronic pain, lasting for more than three months. Being female, increasing age at presentation, higher pain intensity, more widespread non-specific symptoms, or comorbid psychosocial factors are all associated with the development of chronic pain and a worse prognosis. People with significant chronic pain and functional impairment may require specialist treatment, such as injections in the facial muscles.
Botulinum toxin is a purified neurotoxin complex (a toxin that affects nerves), which is derived from the bacterium Clostridium botulinum. It is already in use in the NHS for various indications, but for the treatment of chronic masticatory myofascial pain, it is currently only available as off-label intervention. However, alternative treatment options for this patient group are very limited.
Evidence from small trials and observational studies suggests that injection of botulinum toxin could be beneficial in treating patients with chronic masticatory myofascial pain. The HTA programme therefore wishes to fund the study outlined above, in order to generate evidence that will guide future clinical practice and inform patient choice.
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 research.
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 27 July 2022. Applications will be considered by the HTA Funding Committee at its meeting in September 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 January 2023.
Applications received electronically after 13:00 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