Sciatica
Conditions
Interventions
Patients will be randomized in two groups: A) receiving directly morphine
followed by a taper period (step-down, and B) receiving stepped-up medication
(Step1: paracetamol, Step2: NSAID, Step 3: tramadol, Step 4: morphine).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Women and men aged 18 to 65 years, 2) No use of analgesics besides paracetamol, 3) Radiating (pain) complaints in one leg below the knee, 4) Severity of pain scored 7 or more on an 11-point numerical rating scale (0
Exclusion criteria
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) Co-morbidity that primary determines overall wellbeing such as an osteoporostic fracture, malignity, herpes zoster and Lymes* disease, 6) Hypersensitivity to paracetamol, NSAID or opioids, 7) Previous or active peptic ulcer, 8) Direct indication for surgery (fast progression of paresis or cauda equina syndrome), 9) History of substance addiction or abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes are severity of leg pain. Outcomes will be measured at baseline and at 3,6,9,12 weeks and 1 and 2 years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcomes are adverse reactions, costs, quality of life, patients* perceived recovery, Patients* perceived comfort during tapering of the medication, disability, severity of low back pain, number of days with a severity of leg pain score of 7 or more, compliance to treatment, use of *rescue medication*, patients* satisfactionand co-interventions. Outcomes will be measured at baseline and at 3,6,9,12 weeks and 1 and 2 years follow-up. | — |
Countries
Netherlands
Outcome results
None listed