[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Intervention
Control
Included criteria: All patients with low back pain (with or without leg pain)of less than 6 weeks duration presenting to any of40 participating GPs in Sydney, Australia, were invited toparticipate. The inclusion criterion was a complaint ofpain in the area between the 12th rib and buttock creasecausing moderate pain and moderate disability (measuredby adaptations of items 7 and 8 of SF-367).
Excluded criteria: Exclusioncriteria were: present episode of pain not preceded by apain-free period of at least 1 month, in which care was notprovided; known or suspected serious spinal pathology;nerve root compromise (with at least two of these signs:myotomal weakness, dermatomal sensory loss, orhyporefl exia of the lower limb refl exes); presently takingNSAIDs or undergoing spinal manipulation; any spinalsurgery within the preceding 6 months; andcontraindication to paracetamol, diclofenac, or spinalmanipulative therapy.
Pretreatment: Similar at baseline
Intervention Characteristics
Intervention
Control
Smerteintensitet (pain intensity) 0-12 uger
Funktionsevne (Disability), 0-12 uger
Sponsorship source: The trial was mainly funded by Australia’s National Health and MedicalResearch Council. The active diclofenac was donated by Alphapharm.
Country: Australia
Setting: GPs in Sydney, Australia
Comments:
Authors name: Mark Ha
Institution: University of Sydney, Back Pain Research Group
Email: M.Hancock@usyd.edu.au
Address: Mark Hancock, University ofSydney, Back Pain ResearchGroup, PO Box 170, Lidcombe,NSW 1825, Australia
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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 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 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.
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.
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
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.