Box 1. STEP-UP trial design
DesignA pragmatic, multicentre, open-label, randomised controlled trial with parallel group design, in general practices with a 3-month follow-up period
SettingGeneral practices in the southwestern area of the Netherlands
ObjectiveTo assess the clinical and cost-effectiveness of two pain medication prescription strategies in general practice over a 12-week period
Eligibility criteriaInclusion criteria

  1. Age 18–65 years

  2. No use of opioids

  3. Radiating (pain) complaints in one leg below the knee

  4. Severity of radiating leg pain scored ≥7 on an 11-point numerical rating scale (0 = ‘no pain’; 10 = ‘worst pain imaginable’)

  5. Duration of the (pain) complaints <12 weeks

  6. Presence of at least one of the following symptoms:

    1. More pain on coughing, sneezing, or straining

    2. Decreased muscle strength in the leg

    3. Sensory deficits in the leg

    4. Decreased reflex activity in the leg

    5. Positive straight leg raising test

Exclusion criteria

  1. An episode of radiating (pain) complaints in the preceding 6 months

  2. Back surgery in the past 3 years

  3. Treated with epidural injections

  4. Pregnancy

  5. Comorbidity that primary determines overall wellbeing (for example, an osteoporotic fracture, malignity, herpes zoster, or Lyme’s disease)

  6. Hypersensitivity to paracetamol, NSAID, or opioids

  7. Previous or active peptic ulcer

  8. Direct indication for surgery (fast progression of paresis of cauda equine syndrome)

  9. History of substance addiction or abuse

OutcomePrimary outcome was the severity of radiating leg pain measured daily over a 6-week follow-up period using an 11-point numerical rating scale (score range 0–10), with a higher score indicating more pain.