[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Acupuncture
Sham acupuncture
Included criteria: Adults able to give informed consent, males and femalesaged 18—70 years. Current episode of non-specific LBP, withor without referred pain, of up to 12 weeks duration. LBPwas defined as pain localised below the lowest ribs, andabove the inferior gluteal folds, with or without radiationto the lower extremities.12
Excluded criteria: Pain lasting more than 12 weeks. Presentation of red flagsas defined by the Clinical Standards Advisory Guidelines13;contra-indications to acupuncture or previous acupuncturetreatment; conflicting or ongoing treatment.
Pretreatment: No significant differences between the two groups were identified;however the placebo group had higher scores on VASand RMDQ at baseline
Intervention Characteristics
Acupuncture
Sham acupuncture
pain
Disability
Days off work
Sponsorship source:
Country:
Setting:
Comments:
Authors name: S. Kennedya, G.D. Baxterb, D.P. Kerra, I. Bradburya, J. Parkc, S.M. McDonougha,∗
Institution: Health and Rehabilitation Sciences Research Institute, School of Health Sciences, University of Ulster, Northern Ireland, United Kingdom
Email: s.mcdonough@ulster.ac.uk (S.M. McDonough).
Address: Tel.: +44 2890366459; fax: +44 2890368068.
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Acupuncture
Medicine
Acupuncture + medicine
Included criteria: Acute lower back pain, restricted movements, oraccompanied with radiating leg pain. The diseaseduration was less than 2 weeks, and there was nohistory of back pain in past 4 weeks before theonset.
Excluded criteria: Lumbar trauma, spine-derived pain (tumor,inflammation, infection, fracture, or syndrome ofcauda equina); muscular weakness, sensoryparalysis, weakness or hyperfunction of tendonreflex; history of peptic ulcer; recent medicalhistory of nonsteroidal anti-inflammatory drug(NSAIDs) or anticoagulant, allergic history ofNSAIDs; severe abnormal function of heart, liver orkidney.
Pretreatment: There were no significant difference ingender, age and duration among the three groups
Intervention Characteristics
Acupuncture
Medicine
Acupuncture + medicine
pain
Disability
Sponsorship source: not reported
Country: Kina
Setting: hospital - outpatients
Comments:
Authors name: LIU Jing (刘静), LI Ning (李宁)
Institution: Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing 210028, P. R. China
Email:
Address: Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing 210028, P. R. China
Language
Wrong intervention
Language
Wrong study design
Wrong comparator
Wrong comparator
Wrong outcomes
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 outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Quote: "The primary researcher, who was unaware of patient allocation until the completion of the data analysis, carried out data collection at all time points."
No info
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.
Judgement Comment: Blinding of patients, but not clinicians - however, unlikely to influence results
No info
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.
Quote: "Outcome data were obtained from 94% of participants at the end of treatment; at 3 months follow up this had reduced to 83%. Reasons given for not complet- ing treatment were: no benefit gained, no time available, and work commitments."
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: No protocol
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.
Quote: "To ensure concealment of allocation, an administrative assis- tant not otherwise involved in the study held the randomization list."
No info
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Quote: "Subjects were randomly allocated into groups using a computer generated randomization table (http://www.randomization.com)."
No info
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: Statistical analysis not reported