Step-down versus step-up analgesics in patients with (sub)acute sciatica in primary care.

Rationale:

A systematic review and meta-analysis (2012) reported that the efficacy and tolerability of pain medication commonly prescribed for the management of sciatica in primary care is unclear. There are no data available about the (cost)-effectiveness regarding the recommended stepped medication care in patients with sciatica.



Objective:

What is the effectiveness and cost-effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners’ clinical guideline in patients with (sub) acute sciatica, over a period of 6 and 12 weeks respectively?



Study design:

A randomized controlled trial with alongside an economic evaluation.



Study population:

Patients aged 18 to 65 years (n=234) who are consulting their general practitioner with (sub)acute sciatica with a pain severity of 7 or more on an 11-point numeric rating scale.



Intervention:

Patients will be randomized in two groups: 1) receiving immediate morphine; followed by a taper period (step-down), and 2) receiving stepped-up medication (step1: paracetamol, step2: NSAID, step3: tramadol, step4: morphine).



Main study parameters/endpoints:

The primary outcome is severity of leg pain. Secondary outcomes are adverse reactions, costs, quality of life, patients’ perceived recovery, patients’ perceived comfort during tapering of the medication, disability, pain severity of the low back, number of days with a severity of leg pain score of 7 or more, compliance to treatment, use of ‘rescue medication’, patients’ satisfaction, and co-interventions.
Outcomes will be measured at baseline and at 3,6,9,12 weeks follow-up.

1. What is the effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners’ clinical guideline in patients with (sub)acute sciatica, over a period of 6 weeks?
2. What is the cost-effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners’ clinical guideline in patients with (sub)acute sciatica, over a period of 12 weeks?

All participating patients will fill in the questionnaires at baseline and at 3,6, 9, 12 weeks. During the first 6 weeks the patients will be fill in an online diary.

Group 1: Step-down: Immediate Morphine, with tapering period.

Group 2: Step-up: First Paracetamol, Second NSAID, Thrith Tramadol, Fourth Morphine. (according general practitioners’ clinical guideline).