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 |
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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) |
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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 |
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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. |
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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. |
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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 |