Spinal manual therapy versus nerve root injection for the management of primary care patients with lumbar radiculopathy: the SALuBRITY randomized clinical trial

Sciatica—also called lumbar radiculopathy—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 that affects everyday life. It is also very common—low back pain with leg pain affects about 200 million people worldwide and is one of the leading causes of disability in Switzerland and globally.

People with sciatica usually see their general practitioner first, and are commonly given steroids, opioids, or nerve root injections for pain. Although sciatica is common, little is known about the effectiveness of common non-drug based conservative treatment options, such as spinal manual therapy. High-quality research investigating the pragmatic question of the effect of spinal manual therapy on sciatica-related leg pain is needed. This will assist patients, clinicians, and policymakers with better information to guide treatment decisions and improve healthcare for sciatica.

We propose the SALuBRITY trial in patients with sciatica—a two-parallel-group, multicentre, double-sham-controlled, randomised trial with an embedded patient and public involvement subproject, an internal pilot (vanguard) phase, and a cost-effectiveness analysis.

Objectives: Patient and public involvement – To improve the research quality and relevance of the SALuBRITY trial using consultation and collaboration approaches with a group of patients with lived experience of sciatica and primary care clinicians that care for patients with sciatica.

Vanguard phase – To assess the feasibility and acceptability of the main trial at 12-weeks after randomisation and obtain estimates of parameters to recalculate the sample size for the main trial.

Main trial – To compare spinal manual therapy with steroid 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.

Relevance: Results of the SALuBRITY trial will be directly applicable to the Swiss setting, and will assist patients, clinicians, and policymakers in their decisions on sciatica treatment, helping to improve patient care in Switzerland and worldwide. Results of the trial will contribute to the development of clinical practice guidelines and inform evidence-based recommendations on the use of spinal manual therapy and steroid nerve root injection as part of routine clinical care. We will communicate the trial findings to patients, clinicians, and researchers at major national and international conferences, through publications in peer-review journals, and via knowledge translation efforts with relevant patient associations.