Study characteristics |
Methods |
Study design: RCT (NCT01900925)
Setting: USA and Chile, healthcare
Exercise groups: 1
Comparison groups: 1 |
Participants |
Number of participants: 90 (E1 = 47, C1 = 43)
Chronic LBP duration: 18.4 weeks (moderate)
Neurological/radicular symptoms: No participants
Mean age (years): 46
Sex (female): 41% |
Interventions |
Exercise Group 1 (E1): Usual low back pain physiotherapy care as determined by clinician (manual therapy, trunk strengthening, directional preference, flexion, mobilisation, traction, counselling, endurance) with hip strengthening exercises and hip mobilisations; type = core strengthening; duration = not specified weeks; dose = not reported; design = partially individualised; delivery = individual; additional intervention = advice/education & psychological therapy & manual therapy
Comparison Group 1 (C1): Other conservative treatment (physical therapy) |
Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Oswestry Disability Index); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Rating of Change Scale))
Follow‐up time periods available for syntheses: 2 weeks (short) |
Notes |
Conflicts of interest: Not reported
Funding source: Not reported
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation used "the roll of a dice by the treating therapist; for allocation, die numbers of 1, 3, and 5 were allocated to one group; die numbers 2, 4, and 6 were allocated to the other group". |
Allocation concealment (selection bias) |
High risk |
No information on treatment allocation concealment |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of patient blinding caused deviation from intended interventions because patients had no control over the delivery of intervention. |
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. Pragmatic part of intervention based on guidelines; explicitly instructed not to perform hip therapy to control group. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for pain were the patients themselves, who could not be blinded due to the nature of the treatments; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Possible that lack of patient blinding could have caused bias in outcome assessment because the exercise programmes could be perceived as better than the control; some outcome data supported this. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Dropout rate at 2 weeks (the only usable time point) was 7% (6/90). |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. Appeared that all patients were analysed according to the allocation to which they were randomised |
Selective reporting (reporting bias) |
Low risk |
1. Study was analysed and reported according to registered protocol (NCT01900925): explicitly stated that "recovery expectations" was dropped due to lack of cross‐cultural applicability. |
Groups similar at baseline (selection bias) |
Low risk |
Groups were similar on all relevant characteristics at baseline. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
Not enough information presented to assess co‐intervention use; anyone using steroidal medication was excluded. |
Compliance acceptable in all groups (performance bias) |
High risk |
Difficult to assess as discharge was variable and there was no set number of sessions to attend |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcome assessments were identical for all patients, regardless of treatment group; 2. Oswestry Disability Index (for function) and Numeric Rating Scale (for pain) are well‐validated tools in the low back pain context. |
Other bias |
Low risk |
Appeared free from other sources of bias |