Acute low back pain
Conditions
Interventions
Patients are randomly allocated to one of the four treatment groups using a concealed allocation procedure:
Group 1: Advice (usual care conforming with the clinical guideline of the Dutch College of
Sponsors
Erasmus MC, department of General Practice
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients with acute non-specific low back pain presenting in general practice; - Aged between 18 and 60 years; - Low back pain of less than 6 weeks duration; - Primary complaint of pain in the area between the 12th rib and buttock crease, with or without radiating leg pain; - Experiencing a new episode of low back pain, preceded by a period of at least one month without low back pain; - Low back pain severe enough to cause at least moderate pain (¡Ý 4 on 0-10 NRS).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Have known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture); - Be currently taking recommended regular doses of analgesics, including paracetamol or diclofenac; - Have had spinal surgery within the preceding 6 months; - Have serious co-morbidities like severe rheumatoid arthritis, cardiac failure, diabetes preventing prescription of paracetamol (eg: liver or renal failure) or diclofenac (e.g. ulcus, gastro-intestinal problems); 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); - Using cumarinederivate, clopidogrel, prasugrel, ticagrelor, acetylsalicylacidderivate, systemic glucocorticoïd, SSRI, venlafaxine, duloxetine, trazodon of spironolactone or other medications that may interact with paracetamol and/or diclofenac; - Known intolerance for paracetamol and/or diclofenac; - Being pregnant or planning to become pregnant during the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low back pain intensity measured daily with an 11-point numerical scale (higher score means more pain). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Disability (Roland Morris Disability Questionnaire) - Patients’ perceived recovery (7-point Likert scale dichotomized into recovered (score 1 ‘complete recovery’ and 2 ‘much improved) and not-recovered (score 3 ‘improvement’ to score 7 ‘worse than ever’)) - Quality of life (EuroQol-5D) - Costs (iMedical Consumption Questionnaire (iMCQ) and iProductivity Cost Questionnaire (iPCQ)) - Time to recovery (pain diary) - Compliance to treatment (digital diary derived from the Brief Medication Questionnaire) - Adverse reactions - Patients’ satisfaction (11-point numerical rating scale; higher score means more satisfaction). - Sleep quality (4 point Likert scale derived from the Pittsburgh Sleep Quality Index (PSQI); scores dichotomized into good sleep quality (score 1 ‘very good’ and 2 ‘fairly good’) and poor sleep quality (score 3 ‘fairly bad’ and 4 ‘very bad’)) - Co-interventions | — |
Contacts
Public ContactB.W. Koes
Dept of General Practice Erasmus MC P.O. Box 2040
Outcome results
None listed