Shin 2013.
Methods | RCT, assessor‐blinded Follow‐up time: 24 weeks Outcomes measured at baseline, 30 minutes, after 2, 4, and 24 weeks |
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Participants |
Population: 58 participants, 24 women and 34 men. Mean age (SD): 38.31 (7.97) years Setting: 2 hospitals in South Korea Inclusion: participants 20 to 60 years with acute LBP of < 4 weeks duration, with or without radiating pain to the limb with an Oswestry Disability Index (ODI) value ≥ 60% as an indicator of severe disability Exclusion: serious disease that could cause LBP (e.g. cancer, vertebral fracture, spinal infection); chronic disease that could interfere with the effect of the treatment or the interpretation of treatment results (e.g. cardiovascular disease, diabetic neuropathy, fibromyalgia); progressive neurological deficit or severe neurological symptoms; conditions inappropriate or unsafe for acupuncture (e.g. haemorrhagic disease, blood coagulation disorders); current intake of corticosteroids, immunosuppressant drugs, psychiatric medicine; experience of gastrointestinal side effects after taking NSAIDs, or current treatment for gastrointestinal disease; pregnancy; and reluctance to accept the treatment regimens or examinations (e.g. X‐ray, MRI) of this study |
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Interventions |
NSAID (i): NSAID injection group, received 1 IM injection of conventional diclofenac (N = 29); FU at 30 minutes, 2, 4, and 24 weeks Reference treatment (ii): Motion Style Acupuncture Treatment (MSAT) group, received 1 session of MSAT (N = 29); FU at 30 minutes, 2, 4, and 24 weeks |
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Outcomes | Mean (SD) pain intensity change from baseline (NRS 0 to 10): (i) 4.17 (3.05), (ii) 5.83 (2.61), P = 0.0305 (2 weeks); (i) 6.84 (1.9), (ii) 6.64 (2.47), P = 0.7221 (24 weeks) Mean improvement in functional status (Oswestry Disability Index) from baseline: (i) 36.34 (29.1), (ii) 56.41 (24.86), P = 0.0066 (2 weeks); (i) 80.83 (13.58), (ii) 73.23 (20.24), P = 0.0995 (24 weeks) Patient global impression of change (PGIC; subjective assessment of improvement): no outcomes at relevant time points Adverse events: there were no adverse events reported |
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Funding | Not mentioned | |
Notes | In both groups, the selection of treatment after the initial treatment session was not restricted because of ethical reasons. This implies the results after the first follow‐up at 30 minutes are not clean, and are difficult to generalise. Declaration of interest: one of the authors was supported by the Korea Institute of Oriental Medicine. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random allocation sequence generated by statistician not involved in data collection or analysis. |
Allocation concealment (selection bias) | Low risk | Randomised numbers were kept in sealed envelopes by a researcher who had no direct contact with study participants. |
Blinding of participants and personnel (performance bias) All outcomes ‐ participants | High risk | Blinding of participants and practitioners was not possible because of the nature of the treatment. |
Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | High risk | Blinding of participants and practitioners was not possible because of the nature of the treatment. |
Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Assessor‐blinding was achieved by blinding the assessor performing outcome assessment and case report form (CRF) data entry to the random allocation. Statistical analysis was performed by an independent statistician who was blinded to the identification of each treatment group, but blinding of participants not possible; therefore unclear risk. |
Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | Unclear risk | Not clearly mentioned, but outcomes presented after 2, 4, 24 weeks for the following number of participants: (i) N = 23, 20, 27; (ii) N = 25, 21, 24. |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Low risk | ITT analysis was performed |
Selective reporting (reporting bias) | Low risk | Trial was registered |
Similarity at baseline characteristics | Low risk | Baseline characteristics similar |
Co‐interventions avoided or similar | High risk | Choice for participants for inpatient or outpatient treatment. Inpatients received an integrative package (herbal medicine, Chuna manipulation, bee venom pharmaco‐acupuncture, acupuncture) for 5 sessions a week, outpatients received 1 to 2 sessions a week. In both groups, the selection of treatment after the initial treatment session was not restricted because of ethical reasons. This implies the results after the first follow‐up at 30 minutes are not clean and difficult to generalise. |
Compliance acceptable | Unclear risk | Not applicable |
Timing outcome assessments similar | Unclear risk | Timing similar |
Other bias | Low risk | None |