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 |