Step-down versus step-up analgesics in patients with (sub)acute sciatica in primary care
- Conditions
- Patients with (sub)acute sciatica in primary care.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-002177-11-NL
- Lead Sponsor
- ZonMW GGG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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, and 4) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method