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. 2021 Sep 28;2021(9):CD009790. doi: 10.1002/14651858.CD009790.pub2

Phattharasupharerk 2019a.

Study characteristics
Methods Study design: RCT
Setting: Thailand, occupational
Exercise groups: 1
Comparison groups: 1
Participants Number of participants: 72 (E1 = 36, C1 = 36)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 35
Sex (female): 64%
Interventions Exercise Group 1 (E1): Qigong: Wu Chi meditation and static exercises performed standing in place, and involve various repeated movements with the arms and/or hands; type = other (Qigong); duration = 6 weeks; dose = low; design = standardised; delivery = group; additional intervention = relaxation & other
Comparison Group 1 (C1): Usual care/no treatment (waiting‐list group)
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Perceived Effect scale))
Follow‐up time periods available for syntheses: 6 weeks (short)
Notes Conflicts of interest: None to declare
Funding source: 90th Anniversary of Chulalongkorn University Fund (Ratchadaphiseksomphot Endowment Fund) (Grant Number 59, 2560)
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer program randomised participants equally into two groups.
Allocation concealment (selection bias) Low risk Treatment codes were placed sequentially in numbered, sealed opaque envelopes.
Blinding of participants and personnel (performance bias)
All outcomes Low risk 1. Patients could not be blinded due to the nature of the intervention (active qigong versus waiting list); 2. Lack of patient blinding unlikely to lead to deviations from protocol, as they required professional instruction, and control group was promised future intervention (on waiting list).
Blinding of care provider (performance bias) Low risk 1. Care providers could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of care provider blinding caused deviations from the intended interventions because each provider only interacted with one treatment group after allocation
Blinding of outcome assessment (detection bias)
All outcomes High risk 1. For outcomes of interest (pain and disability), the outcome assessors were the participants, who could not be blinded due to the nature of the interventions; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Likely that outcome assessment was altered by lack of blinding because participants on waiting list knew they were receiving no treatment; reflected in outcome results.
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. In total, 7 out of 72 (9.7%) participants dropped out of the study.
Participants analysed in group allocated (attrition bias) Low risk 1. Intention‐to‐treat analysis was used.
Selective reporting (reporting bias) Low risk 1. No protocol found. All planned analyses were executed and reported for all primary and secondary outcomes within the context of this publication; no obvious omissions.
Groups similar at baseline (selection bias) Low risk All characteristics were similar between groups at baseline; only important characteristic that wasn't measured was the duration of symptoms.
Co‐interventions avoided or similar (performance bias) Low risk Patients were excluded if they took any medication during the study period; participants were asked to avoid other forms of treatment during the study period.
Compliance acceptable in all groups (performance bias) Low risk Two participants in the Qigong group missed one session out of six sessions; otherwise, participants were 100% compliant.
Timing of outcome assessment similar in all groups (detection bias) Low risk 1. For each outcome, all participants were assessed at the same time point and using the same tools; 2. Visual Analogue Scale (for pain) and Roland‐Morris Disability Questionnaire (for disability) are well‐validated scales in the context of low back pain.
Other bias Low risk Missing data could also be managed by using the last‐observation‐carried‐forward method. Since dropouts were balanced in both groups, unlikely to cause bias to results