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. 2020 Dec 11;2020(12):CD013814. doi: 10.1002/14651858.CD013814

Cho 2013.

Study characteristics
Methods Two‐arm RCT
Number analyzed/randomized: 116/130
Statistical analysis: per‐protocol analysis; Student's t‐test and mixed model; power analysis
Funding source: Korea Health Industry Development Institute (B080048)
Ethical approval and informed consent obtained
Participants Participant recruitment: local newspapers, hospital's magazine, website, and bulletin boards
Setting: three medical hospitals in Korea
Inclusion criteria: 1) chronic LBP ≥ 3 months before acupuncture treatment; 2) baseline VAS (bothersomeness, 0 to 10) > 5 points; 3) nonspecific and uncomplicated LBP that was intact on neurological examination
Exclusion criteria: 1) sciatic pain; 2) pain mainly below knee; 3) serious spinal disorders including malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, and cauda equine compression; 4) history of previous spinal surgery
Age (mean ± SD): 42.1 ± 14.0 years
Gender (female): 85%
Pain duration (mean ± SD): NR
Pain intensity (mean ± SD): 6.45 ± 1.30 (VAS, 0 to 10)
Interventions 1) GROUP 1: verum acupuncture (semi‐standardized)
Acupuncture points (according to the diagnosis): gallbladder meridian pattern ‐ GB12, GB26, GB30, GB34, GB41; bladder meridian pattern ‐ BL23, BL24, BL25, BL37, BL40; mixed pattern: ST4, ST36, SP13, SP14, GV3, GV4, GV5, GV24, and GV26
Depth: needles inserted vertically to a depth of 5 to 20 mm, depending on the site
De Qi: needles left in situ for 15 to 20 min after De Qi sensation elicited by manual stimulation
Sessions: 12 sessions (2/week for 6 weeks)
Acupuncturist experience: licensed Korean Medicine Doctors with at least 3 years experience
2) GROUP 2: sham acupuncture
Same technique and protocol as verum acupuncture except that semi‐blunt needles were used without penetration on 8 predefined non‐acupuncture points (1 cm below BL39, 1 cm lateral to BL18 and BL20, and 2 cm above GB30, all bilaterally)
3) Co‐intervention: participants were requested to do exercises every day according to the given manual; any additional therapy was prohibited.
Duration of treatment: 6 weeks
Duration of follow‐up: 24 weeks
Outcomes 1) Pain intensity: VAS (0 to 10)
2) Back‐specific function status: Oswestry Disability Index (ODI, 0 to 50)
3) Quality of life: SF‐36, higher values better
Assessment times: 6,8,12, and 24 weeks after beginning of treatment
Costs: NR
Adverse effects: 16/27 participants reported minor to moderate adverse events, none of which persisted longer than 1 weeks.
Notes Conclusion: “This randomised sham‐controlled trial suggests that acupuncture treatment shows better effect on the reduction of the bothersomeness and pain intensity than sham control in participants with chronic LBP.”
Language: English
Using the baseline SDs of SF‐36 and ODI as the corresponding SDs of the results in meta‐analysis
For results, see comparison 1.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation code generated by computer
Allocation concealment (selection bias) Low risk The random code was kept by a clinician who did not contact participants.
Blinding of participants (performance bias) 
All outcomes Low risk Subjects were blinded and assessment showed adequate blinding.
Blinding of personnel /care providers (performance bias) 
All outcomes Unclear risk Unclear if acupuncturist was successfully blinded or not
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded participants reported the outcomes.
Incomplete outcome data (attrition bias)
All outcomes Low risk Acceptable and balanced dropout rate (11%) across groups; the reasons were largely acceptable.
Intention‐to‐treat‐analysis (attrition bias) High risk The study used per protocol analysis.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Group similarity at baseline (selection bias) Unclear risk The baseline ODI scores in the acupuncture group were significantly higher.
Co‐interventions (performance bias) Unclear risk Unclear risk because the usual care group was visited by a physical therapist twice more than the acupuncture groups.
Compliance bias (performance bias) Low risk Subjects were asked to complete > 80% treatments, and they possibly did, according to the report.
Timing of outcome assessments (detection bias) Low risk Same assessment time
Other bias Low risk Not identified