Study characteristics |
Methods |
Study design: RCT
Setting: United Kingdom, healthcare
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 55 (E1 = 29, E2 = 26)
Chronic LBP duration: 12 weeks (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 37
Sex (female): Not reported |
Interventions |
Exercise Group 1 (E1): Warm‐up (stretching and stationary biking for 10‐15 minutes), general exercises activating extensor (paraspinals) and flexor (abdominals) muscle groups, stabilisation exercises (isometric and low‐loading) increasing in contraction and duration; type = mixed; duration = 8 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education
Exercise Group 2 (E2): Warm‐up (stretching and stationary bike 10‐15 minutes), general exercises activating extensor (paraspinals) and flexor (abdominals) muscle groups; type = mixed; duration = 8 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 8 weeks (short); 20 weeks (moderate) |
Notes |
Conflicts of interest: Not reported
Funding source: Greek State Scholarship Foundation (1KY), Athens, Greece (grant T104830098); Hospital Saving Association, London, United Kingdom
Other: Information modified for author contact |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
This procedure was undertaken by an independent trial manager. |
Allocation concealment (selection bias) |
Low risk |
Randomisation codes were kept in sealed envelopes with consecutive numbering. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Patients were not aware of the theoretical bases of each of the exercise regimens. |
Blinding of care provider (performance bias) |
High risk |
The clinical physical therapist (FR) who administered the exercise programmes could not be masked to group allocation. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The research physical therapist who was in charge of the study and performed the outcome assessments of subjects was unaware of the group allocation throughout the study. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
From the 55 randomly assigned subjects, 10 dropped out of the programme (n = 5 per group), most of them due to time constraints. |
Participants analysed in group allocated (attrition bias) |
Low risk |
All analyses were performed primarily according to the "intention‐to‐treat" (ITT) principle. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
Only the Visual Analogue Scale baseline data were different between groups (Table 2): all other variables were considered sufficiently similar. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
Author contact: did not measure, although it is possible. |
Compliance acceptable in all groups (performance bias) |
Low risk |
Adherence data for clinic‐based exercise were normally distributed. |
Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |