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

Keane 2017.

Study characteristics
Methods Study design: RCT
Setting: England, general population
Exercise groups: 2
Comparison groups: 1
Participants Number of participants: 29 (E1 = 10, E2 = 10, C1 = 9)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: No participants
Mean age (years): 47
Sex (female): 83%
Interventions Exercise Group 1 (E1): Aquastretch: assisted stretching of the whole body in water; type = stretching; duration = 12 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): Land based stretching; type = stretching; duration = 12 weeks; dose = low; design = standardised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention)
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Modified Oswestry Disability Index Oswestry Low Back Pain (MOLBPQ))
Follow‐up time periods available for syntheses: 12 weeks (short)
Notes Conflicts of interest: Not reported
Funding source: No funding received
Other: Information modified for author contact
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Subjects were assigned randomly; sequence generation not described.
Allocation concealment (selection bias) Low risk Sealed envelopes were used.
Blinding of participants and personnel (performance bias)
All outcomes High risk 1. Not mentioned, but due to nature of intervention patients were likely not blinded; 2. Control group maintained pre‐trial regimen; may not be consistent controls; two exercise groups were different enough that expectations may have differed; 3. Control group maintained pre‐trial regimen (i.e. exercise) but did not receive anything from this study; this may bias them as control; 4. Treatments in the control group may have altered outcomes.
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. Unlikely that control group had no contact with care providers and other interventions were explicit (land versus pool)
Blinding of outcome assessment (detection bias)
All outcomes High risk 1. Outcomes in question were pain and function which were assessed by the patients who were not blinded; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. One group was control, while the other two received different interventions.
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. 69% of people recruited took part, but one dropped out after the study started.
Participants analysed in group allocated (attrition bias) Low risk 1. Not explicitly mentioned, however, it seemed like intention‐to‐treat was done; no dropouts and no deviations mentioned
Selective reporting (reporting bias) Low risk 1. No obvious omissions despite lack of linked protocol
Groups similar at baseline (selection bias) Low risk No significant differences in baseline age; there were other important variables such as body mass index and pain duration that were not reported on.
Co‐interventions avoided or similar (performance bias) Low risk Co‐interventions were avoided for exercise groups; no new interventions were recommended for the controls.
Compliance acceptable in all groups (performance bias) High risk No information on compliance with assigned intervention; unlikely to be perfect compliance
Timing of outcome assessment similar in all groups (detection bias) Low risk 1. All subjects submitted visual analogue scale measures by email once a week; all Modified Oswestry Low Back Pain Questionnaire questionnaires were completed at the first meeting and again at weeks 6 and 12 2. Visual Analogue Scale and Modified Low Back Pain Disability Questionnaire are valid measures.
Other bias Low risk No other obvious sources of bias