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. 2021 Sep 28;2021(9):CD009790. doi: 10.1002/14651858.CD009790.pub2

Koumantakis 2005.

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.