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

Hagen 2010.

Study characteristics
Methods Study design: RCT
Setting: Norway, healthcare
Exercise groups: 1
Comparison groups: 1
Participants Number of participants: 246 (E1 = 124, C1 = 122)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 41
Sex (female): 51%
Interventions Exercise Group 1 (E1): Warm‐up, circuit training (10 stations of strengthening and balance exercises), stretching (after a 2 week spine clinic intervention); type = mixed; duration = 8 weeks; dose = high; design = partially individualised; delivery = independent; additional intervention = advice/education & relaxation
Comparison Group 1 (C1): Other conservative treatment (education)
Outcomes Core outcomes reported: Pain (Low Back Pain Rating Scale (Manniche)); function (Roland‐Morris Disability Questionnaire); work (sick leave (total length of leave, frequency of sick leave periods))
Follow‐up time periods available for syntheses: 12 weeks (short)
Notes Conflicts of interest: Not reported
Funding source: Norwegian Foundation for Health and Rehabilitation (Grant No. Nkr 840 000)
Other: Sufficient data not available for inclusion in meta‐analyses
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The concealed randomisation was made according to a list prepared in advance at the University of Bergen (Norwegian Back Pain Network, Research Unit).
Allocation concealment (selection bias) Low risk A secretary at the Research Unit was responsible for the randomisation procedures and was not involved in the treatment of the patients.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not described
Blinding of care provider (performance bias) High risk Not described
Blinding of outcome assessment (detection bias)
All outcomes Low risk At the first visit at the spine clinic, before randomisation, all patients were examined by a physiotherapist using six different tests.
Incomplete outcome data (attrition bias)
All outcomes Low risk Eight participants dropped out.
Participants analysed in group allocated (attrition bias) Low risk Those with zero attendances were still considered as participants in the exercise group, according to the intention‐to‐treat principle.
Selective reporting (reporting bias) Unclear risk Not described
Groups similar at baseline (selection bias) Unclear risk There were few baseline characteristics available to be able to assess group differences.
Co‐interventions avoided or similar (performance bias) Unclear risk Not described
Compliance acceptable in all groups (performance bias) Unclear risk Range of attendances in the physical exercise programme for the intervention group was 0‐24; median 15.0.
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.