| Design | A pragmatic, multicentre, open-label, randomised controlled trial with parallel group design, in general practices with a 3-month follow-up period |
| Setting | General practices in the southwestern area of the Netherlands |
| Objective | To assess the clinical and cost-effectiveness of two pain medication prescription strategies in general practice over a 12-week period |
| Eligibility criteria | Inclusion criteria
Age 18–65 years No use of opioids Radiating (pain) complaints in one leg below the knee Severity of radiating leg pain scored ≥7 on an 11-point numerical rating scale (0 = ‘no pain’; 10 = ‘worst pain imaginable’) Duration of the (pain) complaints <12 weeks Presence of at least one of the following symptoms: More pain on coughing, sneezing, or straining Decreased muscle strength in the leg Sensory deficits in the leg Decreased reflex activity in the leg Positive straight leg raising test
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Exclusion criteria
An episode of radiating (pain) complaints in the preceding 6 months Back surgery in the past 3 years Treated with epidural injections Pregnancy Comorbidity that primary determines overall wellbeing (for example, an osteoporotic fracture, malignity, herpes zoster, or Lyme’s disease) Hypersensitivity to paracetamol, NSAID, or opioids Previous or active peptic ulcer Direct indication for surgery (fast progression of paresis of cauda equine syndrome) History of substance addiction or abuse
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| Outcome | Primary 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. |