Costantino 2014.
Methods | RCT | |
Participants | 54 participants. 1. Back School group n = 27. 2. Hydrotherapy group n = 27. Inclusion criteria: participants aged between 65 and 80 years; diagnosis of chronic non‐specific low back pain. Exclusion criteria: presence of musculoskeletal disorders, severe heart failure, or internal medicine pathologies that could interfere with moderate physical activity; fever or infectious disease; systemic inflammatory or rheumatologic diseases; previous spinal surgery or a history of vertebral traumas/fractures; instrumental physical therapies or physiotherapeutic therapies in the previous 3 months. |
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Interventions | 1. Back School group: In the first session, individuals were informed about the anatomy of the spinal column, its functioning and ergonomic position and the basis of the pain‐inducing mechanism, psychological aspects and stress management, whereas in the following sessions they performed stretching and muscular strengthening, associated with proper breathing. 2. Hydrotherapy group: Participants at first performed walking exercises to adapt to the pool conditions, and afterwards performed bilateral stretching and selective muscle strengthening exercises. |
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Outcomes | 1. Disability: Roland‐Morris Disability Questionnaire. | |
Notes | Setting not specified. Funding: N/A. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The participants were randomly allocated using computer randomisation software (RANDI2 software version 0.6.1) to the Back School programme (group A) or to the hydrotherapy programme (group B). |
Allocation concealment (selection bias) | Unclear risk | The sequence generation procedure or the method of allocation were not mentioned. The title and abstract indicate that it is an RCT. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of any attempts to blind the participants |
Blinding (performance bias and detection bias) All outcomes | High risk | No mention of any attempts to blind the care providers |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention of any attempts to blind the assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The percentage of withdrawals and dropouts was within the acceptable rate (less than 20%). |
Intention‐to‐treat Analysis | Low risk | All analyses were performed based on the intention‐to‐treat principle. |
Selective reporting (reporting bias) | Low risk | It was clear that the published report included all expected outcomes. |
Similarity of baseline characteristics? | Low risk | No significant difference across the groups was found. |
Co‐interventions avoided or similar? | Low risk | Balanced for both groups |
Compliance acceptable? | Low risk | Compliance was acceptable based on the reported intensity/dosage, duration, number, and frequency for both the intervention and control groups. |
Timing outcome assessments similar? | Low risk | All important outcomes assessments for both groups were measured at the same time. |