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 |