Efficacy of paracetamol and diclofenac for patients with acute low back pain: a randomized placebo controlled trial (PACE plus trial) - PACE plus trial

niversitair Medisch Centrum0 个研究点目标入组 600 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- 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.

•- 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.

发起方

niversitair Medisch Centrum