| Study characteristics |
| Methods |
Study design: RCT (NCT00993980)
Setting: Germany, general population
Exercise groups: 2
Comparison groups: 0 |
| Participants |
Number of participants: 127 (E1 = 64, E2 = 63)
Chronic LBP duration: 2.95 years (moderate)
Neurological/radicular symptoms: Not specified
Mean age (years): 47
Sex (female): 81% |
| Interventions |
Exercise Group 1 (E1): Qigong: 21 movements for spine and legs (14 in level 1, 7 in level 2); type = other (Tai Chi, Qigong); duration = 12 weeks; dose = high; design = standardised; delivery = group; additional intervention = none
Exercise Group 2 (E2): Dynamic gym ball exercises followed by strengthening and stretching exercises; type = mixed; duration = 12 weeks; dose = low; design = standardised; delivery = group; additional intervention = relaxation |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: None to declare
Funding source: Karl and Veronica Carstens Foundation
Other: SDs imputed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Block randomisation with list from the 'ranuni' random number generator of the SAS/Stat software |
| Allocation concealment (selection bias) |
Low risk |
Randomised using a button |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
In the recruitment and patients’ information, both interventions were described as similar useful and plausible for treating low back pain. |
| Blinding of care provider (performance bias) |
High risk |
Neither patients nor therapists were blinded to the treatment. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
In the recruitment and patients’ information, both interventions were described as similarly useful and plausible for treating low back pain. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
See Figure 1 |
| Participants analysed in group allocated (attrition bias) |
Low risk |
Analysis was based on available data (full analysis set based on intention‐to‐treat). |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
High risk |
More women in the Qigong group; Qigong group had higher school education; Qigong participants had shorter LBP duration. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Same medication as usual allowed; no complimentary treatments |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Described as "high" |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Both groups assessed at three, six, and 12 months |
