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. |