[Summary text]
Study design: Randomized controlled trial
Study grouping:
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Kontrol
Included criteria: Adults aged 21 to 64 years who presented to the ED primarily formanagement of acute LBP, defined as pain originatingbetween the lower border of the scapulae and the upper glutealfolds, and received a diagnosis consistent with nontraumaticnonradicular, musculoskeletal LBP. Patients wererequired to have functionally impairing back pain, which wedefined as a score of greater than 5 on the Roland-MorrisDisability Questionnaire (RMDQ)
Excluded criteria: radicular pain, which we defined as pain radiating below thegluteal folds, direct trauma to the back within the previousmonth, pain duration for more than 2 weeks, or recent historyof greater than 1 LBP episode per month. We alsoexcluded patients who were pregnant or lactating, unavailablefor follow-up, with allergy or contraindication to theinvestigational medications, or had chronic opioid use currentlyor in the past
Pretreatment: Eneste parameter der skiller sig ud er "Duration of LBP...", hvor gruppen der får placebo i gennemsnit har haft LBP i 48 timer, mens gruppen der får opioid har haft smerter et døgn længere (72t.) - og der er her en lille overvægt af kvinder 46:64 m/k, mens der i placebo gruppen er 50:50
Intervention Characteristics
Intervention
Kontrol
Funktionsevne (Disability) 0-12 uger
Sponsorship source: Not reported
Country: USA
Setting: Emergency department
Comments: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Authors name: Benjamin W. Friedman et al
Institution: Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York
Email: bwfriedmanmd @gmail.com
Address: BenjaminW.Friedman, MD,MS, Department ofEmergency Medicine, MontefioreMedical Center, Albert EinsteinCollege of Medicine, 111 E 210th St,Bronx, NY 10467
Fagkonsulent Nkr40 on 21/03/2016 20:11
Included
Protokol tilgængelig via URL
Ture Karbo on 28/03/2016 08:33
Interventions
I: Naproxen+ Oxycodone-acetaminophenK: Naproxen+ Placebo
Ture Karbo on 28/03/2016 09:23
Outcomes
Primary outcome: improvement in RMDQ between ED visit and 1-week follow-upDer mangler plads til resp. RMDQ-improvement efter 3 mdr. Intervention = 4.6 (3.2 to 6.1) Kontrol = 3.8 (2.6 to 5.1)
Wrong patient population
Wrong outcomes
Wrong outcomes
Wrong intervention
Wrong intervention
Wrong patient population
Wrong patient population
Wrong route of administration
Wrong study design
Wrong study design
Wrong study design
Wrong study design
Wrong patient population
Wrong outcomes
Wrong patient population
Wrong intervention
Wrong intervention
Wrong patient population
Wrong patient population
Wrong patient population
Wrong intervention
Wrong study design
Wrong patient population
Wrong study design
Wrong patient population
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Judgement Comment: The pharmacisit performed a stratified randomization in block of 6 based on 2 sequences using a randomization plan generator
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: None
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Patient reported outcome measure - patients blinded