MEDications in Acute Low back pain: the MEDAL trial

Problem

Background: Acute low back pain (LBP) is a common presentation in general practice and evidence surrounding analgesic approaches is uncertain nor have escalation strategies been robustly investigated through trials. The MEDAL trial (HTA 21/540 themed call) was developed and funded to trial analgesic escalation approaches. General practice is however under unprecedented levels of stress to and so innovative approaches are needed to allow trials to be delivered in this setting without impacting on care delivery.

Approach

Trial Design: The MEDAL trial is a pragmatic, multi-centre, open label, individually randomised, controlled, adaptive platform trial of 6 analgesic ladders for acute LBP, acute LBP with referred somatic leg pain, and sciatica (sample size of 3960). The trial programme comprises, analgesic ladder development, pilot study, main trial, health economic evaluation and qualitative study to gain in-depth understanding of the experiences of patients and clinicians taking part in the trial. This design may also allow the opportunity for additional ladders to be trialled.

PPIE and EDI: PPIE has been integral to the MEDAL trial at all stages from funding application to final development of participant facing documents. We have worked with 3 primary care networks that serve the most underserved and diverse communities in the West Midlands who will be supported to deliver the MEDAL trial through their member practices.

Setting: The MEDAL trial will be delivered in general practices but has been developed through a cross setting and multiple stakeholder collaboration, including spinal orthopaedics, general practitioners, pharmacists, pharmacologists, pain clinicians, community members, patients with lived experience and the clinical research network.

Analgesic ladder development: A four stage consensus exercise involving GPs, pharmacists, pharmacologists and prescribing health care professionals was used to develop the 6 analgesic ladders to be tested in the MEDAL trial.

Statistical considerations: A Bayesian adaptive design will be used. The use of hierarchical modelling for the trial’s analysis will also be explored.

Findings

Innovation: This, as far as we are aware, the first adaptive platform trial to investigate analgesic escalation approaches in primary care taking a multi-setting and collaborative approach. As such the trial design and statistical modelling represent innovation in itself. We have also developed digital solutions allowing automatic pre-screening and safety checking through the electronic health record systems, remote consent, electronic data collection and follow up, and analgesic escalation processes.

Consequences

Implications: given the current pressures on general practice to deliver care innovative approaches exploiting digital solutions and new methodologies need to be developed to allow robust trials to be delivered in primary care settings where the majority of patient care occurs. The MEDAL trial has been developed with that aim to execute a large trial to answer an important research question whilst limiting impact on general practice.