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

Woods 2008.

Study characteristics
Methods Study design: RCT
Setting: Canada, mixed
Exercise groups: 1
Comparison groups: 2
Participants Number of participants: 44 (E1 = 13, C1 = 16, C2 = 15)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 46
Sex (female): 66%
Interventions Exercise Group 1 (E1): Graded activity: the shaping of healthy behaviours through positive reinforcement of predefined activity quotas (Vlaeyen 2002); type = other (graded activity); duration = 4 weeks; dose = low; design = individualised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (waiting‐list group)
Comparison Group 2 (C2): Other conservative treatment (psychological therapy)
Outcomes Core outcomes reported: Pain (McGill Pain Score); function (Pain Disability Index)
Follow‐up time periods available for syntheses: 4 weeks (short); 8 weeks (short)
Notes Conflicts of interest: Not reported
Funding source: Royal Bank of Canada; Canadian Institutes of Health Research Investigator Award
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk All patients were randomly assigned to one of three conditions via the rolling of a six‐sided dice (a dice roll of 1 and 4 = graded in vivo exposure, 2 and 5 = graded activity)
Allocation concealment (selection bias) High risk Not described
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 High risk Outcome assessors not blinded
Incomplete outcome data (attrition bias)
All outcomes High risk Randomised (n = 83); graded in vivo exposure (n = 36) completed (n = 15), dropouts (n = 21); graded activity (n = 25) completed (n = 13), dropouts (n = 12); wait list control (n = 22) completed (n = 16)
Participants analysed in group allocated (attrition bias) Low risk An intent‐to‐treat analysis, using Analysis of Covariance was conducted.
Selective reporting (reporting bias) Low risk Support for judgement was not available.
Groups similar at baseline (selection bias) Low risk Independent samples t‐tests (for age) and v2 analyses (for sex, education level, and employment status) comparing demographics between conditions showed no differences in characteristics other than sex.
Co‐interventions avoided or similar (performance bias) Unclear risk Not described
Compliance acceptable in all groups (performance bias) Unclear risk Not described
Timing of outcome assessment similar in all groups (detection bias) Low risk Support for judgement was not available.