MedPath

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

Phase 4
Completed
Conditions
Sciatica
10023213
10041543
Registration Number
NL-OMON44314
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
234
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<= no pain; 10<= maximum pain),
5) Duration of the (pain) complaints less than 12 weeks,
6) Presence of at least one of the following symptoms: a) More pain on coughing, sneezing or straining, b) Decreased muscle strength in the leg, c) Sensory deficits in the leg, d) Decreased reflex activity in the leg, e) 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) 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcomes are severity of leg pain.<br /><br>Outcomes will be measured at baseline and at 3,6,9,12 weeks and 1 and 2 years<br /><br>follow-up.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secundary outcomes are adverse reactions, costs, quality of life, patients*<br /><br>perceived recovery, Patients* perceived comfort during tapering of the<br /><br>medication, disability, severity of low back pain, number of days with a<br /><br>severity of leg pain score of 7 or more, compliance to treatment, use of<br /><br>*rescue medication*, patients* satisfactionand co-interventions.<br /><br>Outcomes will be measured at baseline and at 3,6,9,12 weeks and 1 and 2 years<br /><br>follow-up.</p><br>
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