Study characteristics |
Methods |
Study design: RCT
Setting: England, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 97 (E1 = 47, E2 = 50)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 39
Sex (female): 51% |
Interventions |
Exercise Group 1 (E1): Endurance training for deep abdominal and multifidus muscles; type = core strengthening; duration = 12 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = electrotherapy & manual therapy
Exercise Group 2 (E2): Exercise described as 'conventional' treatment; type = mixed; duration = 12 weeks; dose = low; design = individualised; delivery = individual; additional intervention = electrotherapy & manual therapy |
Outcomes |
Core outcomes reported: Pain (Numeric Rating Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate); 52 weeks (long) |
Notes |
Conflicts of interest: None to declare
Funding source: No funding received
Other: SDs imputed |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
An adaptive stratified randomisation procedure was used incorporating minimization, using laterality of symptoms. |
Allocation concealment (selection bias) |
Low risk |
Patients were naive to allocation. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blinding was not possible, so single‐blinding, with a credible alternate treatment was used. |
Blinding of care provider (performance bias) |
High risk |
Double‐blinding was not possible. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double‐blinding was not possible, so‐single blinding, with a credible alternate treatment, was used. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Of 97 patients, nine patients, evenly spread across both groups, did not complete a course of treatment. |
Participants analysed in group allocated (attrition bias) |
Low risk |
For the intention‐to‐treat analysis, data of patients who withdrew or failed to respond to follow‐up were included until they withdrew. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
The clinical and demographic characteristics of the groups were well balanced at randomisation. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
No restriction was placed on prescribed or over‐the‐counter medication but hydrotherapy, back school, or other group therapy was prohibited. |
Compliance acceptable in all groups (performance bias) |
Unclear risk |
Although measured informally, which is representative of much clinical practice, it was a limitation of the study that compliance was not formally measured. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |