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Samenvatting
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Het project was van start gegaan in april 2014. Goedkeuring van de medisch ethische toetsingscommissie van het Erasmus

MC is verkregen in april 2015. Start van uitnodigen van de patiënten was in april 2015. Na 12 maanden waren er te weinig

patiënten (n=8) die meededen met het onderzoek. Daarom is besloten het project voortijdig te beëindigen.

Resultaten
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Het project was van start gegaan in april 2014. Goedkeuring van de medisch ethische toetsingscommissie van het Erasmus

MC is verkregen in april 2015. Start van uitnodigen van de patiënten was in april 2015. Na 12 maanden waren er te weinig

patiënten (n=8) die meededen met het onderzoek. Daarom is besloten het project voortijdig te beëindigen.

Samenvatting van de aanvraag

Samenvatting
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Objective

What is the cost-effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication according general practitioners’ clinical guideline in patients with (sub)acute sciatica?

 

Study design

A randomised controlled trial with alongside an economic evaluation.

 

Study population

Patients aged 18 to 65 years 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: 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).

 

Outcome measures

The primary outcomes are severity of leg pain, the number of days with severe pain, and direct and productivity costs. Secondary outcomes are adverse reactions, perceived recovery, use of rescue medication, disability and quality of life. Outcomes will be measured at baseline and at 3,6,9 and 12 weeks follow-up.

 

Sample size calculation and data analysis

To detect a relevant difference in time returning to work with 4 workdays (with an alpha of 0.05, a power of 80%, two tailed testing) between the two groups, 234 patients are needed. Data analyses will be based on the intention to treat principle. Based on the severity of leg pain and the EuroQol (QALY) a (cost)-effectiveness analysis and a cost-utility analysis will be conducted. The economic evaluation will be conducted from the societal and the health care perspective based on patients’ reports.

 

Time schedule

Total duration is 36 months. The first 6 months for preparation of the study, then a 24-month period for recruitment and follow-up. In the last 6 months data analysis and reporting takes place.

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