Study characteristics |
Methods |
Study design: RCT (NCT02721914)
Setting: Spain, healthcare
Exercise groups: 2
Comparison groups: 1 |
Participants |
Number of participants: 27 (E1 = 9, E2 = 9, C1 = 9)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Not specified
Mean age (years): 29
Sex (female): 85% |
Interventions |
Exercise Group 1 (E1): Combined abdominal hypopressive gymnastics and massage therapy: abdominal hypopressive gymnastics are static postural exercises that aim to strengthen the abdominal girdle and stabilise the spine; type = core strengthening; duration = 5 weeks; dose = low; design = standardised; delivery = individual; additional intervention = manual therapy
Exercise Group 2 (E2): Abdominal hypopressive gymnastics alone, static postural exercises that aim to strengthen the abdominal girdle and stabilise the spine; type = core strengthening; duration = 5 weeks; dose = low; design = standardised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Other conservative treatment (manual therapy) |
Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Oswestry Disability Index); HRQoL (12‐Item Short Form Survey (Spanish))
Follow‐up time periods available for syntheses: 5 weeks (short) |
Notes |
Conflicts of interest: None to declare
Funding source: Not reported
Other: None |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Simple random sampling, "drawing from a hat" |
Allocation concealment (selection bias) |
Low risk |
Treatment allocation was concealed, as patients directly selected their random assignment from an opaque container. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to the intervention due to the nature of the difference interventions (massage versus exercise); 2. Both groups getting sufficient treatment, unlikely to be dissatisfied; experimental hard to access outside of study. |
Blinding of care provider (performance bias) |
Low risk |
1. Care provider could not be blinded because a single physiotherapist performed the treatments for all intervention groups; 2. Explicit set of exercises in protocol |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessors for pain intensity and disability were the patients themselves, who could not be blinded to intervention due to the nature of the interventions; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Likely that massage group was perceived as more effective because it was more direct. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. None of the patients dropped out of the study; all who were randomised were analysed. |
Participants analysed in group allocated (attrition bias) |
Low risk |
1. "The effectiveness of the three applied interventions was examined by the intention‐to‐treat method". |
Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistic analysis plan found: within this publication all outcomes and analyses were fully reported; no obvious lapses. |
Groups similar at baseline (selection bias) |
Low risk |
Groups were relatively similar at baseline for age, sex, function and pain intensity; did not report baseline duration of symptoms. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
One of the exclusion criteria was being under pharmacological treatment (co‐intervention), though it did not specify whether this treatment had to be directly for low back pain. |
Compliance acceptable in all groups (performance bias) |
Low risk |
No direct reporting of compliance, though there seemed to be implication that attendance to treatment sessions was 100%. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. All participants were assessed on pain intensity and function identically, regardless of treatment group assignment; 2. Numeric rating scale (for pain) and Oswestry Disability Index (for function) are well‐validated tools in the low back pain context. |
Other bias |
Low risk |
Appeared free from other sources of bias |