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. 2021 Sep 28;2021(9):CD009790. doi: 10.1002/14651858.CD009790.pub2

Bade 2017.

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