| Project Detail |
Background: Lumbar radiculopathy - also called sciatica - is low back pain that spreads into the leg because of an irritated nerve in the lower back. It can be a very painful and disabling condition, affects about 200 million people worldwide, and is one of the leading causes of disability in Switzerland and globally. Spinal manual therapy and corticosteroid nerve root injections are commonly used to treat patients with lumbar radiculopathy in Switzerland. However, there is uncertainty about their comparative effectiveness and a need for high-quality randomised clinical trial evidence. We propose the SALuBRITY trial - a two-parallel-group, multicentre, double-sham-controlled, randomised noninferiority trial with a patient and public involvement subproject, internal pilot (vanguard) phase, process evaluation, and cost-effectiveness analysis, to compare spinal manual therapy versus nerve root injection for the management of primary care patients with lumbar radiculopathy.Objectives: Vanguard phase - To assess the feasibility of the trial over the first 9 months of recruitment. Main trial - To compare spinal manual therapy with corticosteroid nerve root injection in terms of pain impact at 3 months after randomisation, and assess outcomes important to patients such as pain, function, quality-of-life, and satisfaction over 12 months. Patient and public involvement - To improve the research quality and relevance of the SALuBRITY trial using consultation and collaboration approaches with a small group of patients and primary care clinicians with lived patient and clinician experience of sciatica.Setting: The trial will involve a recruitment network of primary care general practices and a telemedicine call centre service, community-based chiropractic services, and university hospital-based outpatient interventional radiology services in Zurich, Switzerland. A number of research clinics (SALuBRITY sciatica clinics), in which patients are screened for eligibility and recruited to the trial, will be based in primary care chiropractic centres in Zurich.Interventions: Participants will be randomly allocated, in a 1:1 ratio, to active spinal manual therapy plus sham-control nerve root injection or active corticosteroid nerve root injection plus sham-control spinal manual therapy, each intervention administered during a 12-week treatment period.Main outcomes: Vanguard phase outcomes include participant recruitment and follow-up rates over the first 9 months of recruitment; the success of general practice recruitment and retention; the success of telemedicine call centre recruitment and retention; the success of chiropractic site recruitment, including training and engagement; fidelity to the treatment protocols; the proportion of participants allocated to each of the two groups according to the stratification algorithm; and rate of missing data for the primary outcome up to the 3-month follow-up for all participants recruited during the 9 months of the pilot trial phase. The primary clinical outcome will be patient-reported radicular leg pain impact at 3-month follow-up assessed with the PEG scale (a validated 3-item average composite of one pain intensity and two pain interference numerical rating scales). Secondary outcomes include overall pain impact (back and leg pain), disability, patient satisfaction, analgesic use, global improvement, quality of life, health care utilisation, and serious adverse events.Relevance: The SALuBRITY pilot phase results will inform the feasibility and design of the main trial. The SALuBRITY main trial results will help to clarify the effects of spinal manual therapy and nerve root injection in patients with lumbar radiculopathy. This study will assist patients, clinicians, and policy makers with decision-making based on high-quality, clinically relevant evidence, helping to optimise appropriate health care delivery for lumbar radiculopathy in Switzerland and worldwide. |
