pijn acute low back pain
Conditions
Interventions
Study treatments:
Group 1: Paracetamol 4dd1000 mg + placebo diclofenac 2dd
Group 2: Diclofenac 2dd75 mg + placebo paracetamol 4dd
Group 3: Placebo paracetamol 4dd + placebo diclofenac 2dd
Since the d
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Mentally competent patients (male and female) presenting in general practice with acute non-specific low back pain; - Between 18 and 60 years old; - Experiencing a new episode of low back pain, preceded by a period of at least one month without low back pain; - Duration of pain less than 6 weeks (in accordance with the Cochrane Collaboration Back Review Group definition for 'acute' pain; - Primary complaint of pain in the area between the 12th rib and buttock crease, with or without leg pain; - Low back pain severe enough to cause at least moderate pain (* 4 on 0-10 Numerical Rating Scale (NRS); - Signed consent form.
Exclusion criteria
Exclusion criteria: - Known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture); - Currently taking recommended regular doses of analgesics conforming with the study protocol (e.g. paracetamol 4dd1000mg, diclofenac 2dd75mg or 3dd50mg); - Spinal surgery within the preceding 6 months; - Serious co-morbidities such as rheumatoid arthritis, heart failure, diabetes, renal insufficiency, gastric ulcers, gastro-intestinal pathology, allergy for paracetamol and/or NSAIDs or other indications preventing prescription of paracetamol and/or NSAIDs; use of proton pump inhibitors before inclusion is not an exclusion criterium, as the patient is considered to be protected (patient will have to continue using this medication during use of study medication); - Use of coumarin derivatives, clopidogrel, prasugrel, ticagrelor, acetylsalicylic acid derivatives, systemic glucocorticosteroids, SSRIs, venlafaxine, duloxetine, trazodone, spironolactone or other medication that may interact with paracetamol and/or diclofenac; - Known intolerance for paracetamol and/or diclofenac; - Patients who are pregnant or planning to become pregnant during the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be pain intensity (11-points numerical rating scale). This will be captured in a (digital) daily pain and medication use diary that particpants will complete over a 4 week follow up period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: 1. Disability measured at baseline and after 2, 4 and 12 weeks of follow up using the Roland Morris Disability Questionnaire (score range 0-24; higher score means more disability); 2. Patients* perceived recovery measured after 2, 4 and 12 weeks of follow-up using a 7-point Likert scale; scores will be dichotomized into recovered or not recovered; 3. Quality of life measured at baseline and after 4 and 12 weeks of follow-up using the EQ-5D-5L; 4. Costs; all direct medical and patient costs measured after 4 and 12 weeks of follow-up using the iMedical Consumption Questionnaire (iMCQ), and productivity costs measured with iProductivity Cost Questionnaire (iPCQ); 5. Time to recovery will be assessed using the daily pain diary. Recovery is defined as the first day of 0 or 1 pain intensity, maintained for 7 consecutive days; 6. Compliance to treatment measured daily using a digital diary. The question that will be used is derived from the Brief Medication Questionnaire; 7. Adverse reactions, systematically recorded in the questionnaires after 2, 4 and 12 weeks of follow-up; 8. Patient satisfaction measured after 2, 4 and 12 weeks of follow-up using an 11-point numerical rating scale; higher score means more satisfaction; 9. Sleep quality measured at baseline and after 2, 4 and 12 weeks of follow-up using a 4 point Likert scale derived from the Pittsburgh Sleep Quality Index (PSQI); scores will be dichotomized into good sleep quality and poor sleep quality; 10. Co-interventions will systematically be recorded in the questionnaires after 2, 4 and 12 weeks of follow-up. All secondary outcomes will be recorded using digital questionnaires. | — |
Countries
Netherlands
Outcome results
None listed