Study characteristics |
Methods |
Study design: RCT (NCT00056212)
Setting: USA, mixed
Exercise groups: 2
Comparison groups: 1 |
Participants |
Number of participants: 101 (E1 = 36, E2 = 35, C1 = 30)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: No participants
Mean age (years): 44
Sex (female): 66% |
Interventions |
Exercise Group 1 (E1): Viniyoga: emphasis on safety with focus on relaxation, strength‐building, flexibility, and strengthening hip muscles, asymmetric poses; type = yoga; duration = 12 weeks; dose = low; design = standardised; delivery = group; additional intervention = relaxation
Exercise Group 2 (E2): Series of 7 aerobic exercises and 10 strengthening exercises emphasizing leg, hip, abdominal, and back muscles, stretching; type = mixed; duration = 12 weeks; dose = low; design = standardised; delivery = group; additional intervention = advice/education & relaxation
Comparison Group 1 (C1): Other conservative treatment (education) |
Outcomes |
Core outcomes reported: Pain (bothersomeness); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate) |
Notes |
Conflicts of interest: None to declare
Funding source: National Center for Complementary and Alternative Medicine (grant R21AT 001215); National Institute for Arthritis and Musculoskeletal and Skin Diseases (grant P60AR48093)
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomly generated treatment assignments for each class series by using a computer program with block sizes of six or nine |
Allocation concealment (selection bias) |
Low risk |
A researcher who was not involved in patient recruitment or randomisation placed the assignments in opaque, sequentially numbered envelopes. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not described |
Blinding of care provider (performance bias) |
High risk |
Not described |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Interviewers who were masked to the treatment assignments conducted telephone interviews at baseline and at six, 12, and 26 weeks after randomisation. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Follow‐up rates remained high, even at 26 weeks (95 of 101 participants completed telephone interviews). |
Participants analysed in group allocated (attrition bias) |
Low risk |
An intention‐to‐treat approach was used. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
No significant differences were found between groups except for pain travelling below knee. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
During the 12‐week intervention, 11% of participants in the yoga group reported making visits to healthcare providers. |
Compliance acceptable in all groups (performance bias) |
Low risk |
Class attendance was similar in the yoga (median classes attended, 9) and exercise (median classes attended, 8) groups (Figure 1). |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |