Study characteristics |
Methods |
Study design: RCT (NCT01761617)
Setting: USA, mixed
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 95 (E1 = 46, E2 = 49)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 48
Sex (female): 75% |
Interventions |
Exercise Group 1 (E1): Two yoga classes per week and home practice; type = yoga; duration = 12 weeks; dose = high; design = standardised; delivery = group; additional intervention = relaxation
Exercise Group 2 (E2): One yoga class per week and home practice; type = yoga; duration = 12 weeks; dose = low; design = standardised; delivery = group; additional intervention = relaxation |
Outcomes |
Core outcomes reported: Pain (Numeric Rating Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (overall improvement (7‐point))
Follow‐up time periods available for syntheses: 12 weeks (short) |
Notes |
Conflicts of interest: Not reported
Funding source: National Center for Complementary and Alternative Medicine (Grant 1R01AT005956), National Institutes of Health
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
The 1:1 randomisation schedule was created in StudyTrax using a permuted block design with randomly determined block sizes (4, 8, 12). |
Allocation concealment (selection bias) |
High risk |
Due to the nature of the interventions, participants and study staff who scheduled classes could not be masked to treatment allocation. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Due to the nature of the interventions, participants and study staff who scheduled classes could not be masked to treatment allocation. |
Blinding of care provider (performance bias) |
High risk |
Due to the nature of the interventions, participants and study staff who scheduled classes could not be masked to treatment allocation. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Support for judgement was not available. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
See flow chart |
Participants analysed in group allocated (attrition bias) |
Low risk |
Support for judgement was not available. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
A couple of characteristics were different but they were used as confounders. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
Reported and seem to be similar across the groups |
Compliance acceptable in all groups (performance bias) |
High risk |
Thirty‐two (65%) and 20 (44%) participants assigned to once‐weekly and twice‐weekly classes, respectively, achieved treatment adherence. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |