Study characteristics |
Methods |
Study design: RCT
Setting: USA, mixed
Exercise groups: 2
Comparison groups: 0 |
Participants |
Number of participants: 28 (E1 = 12, E2 = 16)
Chronic LBP duration: 12 months (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 49
Sex (female): 64% |
Interventions |
Exercise Group 1 (E1): Exercises for postural righting, flexibility, and pain relief, stabilisation and strengthening exercises, functional task performance, home exercise daily 20‐30 minutes; type = mixed; duration = 6 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education & manual therapy
Exercise Group 2 (E2): Daily home exercises (20‐30 minutes); type = mixed; duration = 6 weeks; dose = low; design = not specified; delivery = independent; additional intervention = relaxation |
Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey)
Follow‐up time periods available for syntheses: 6 weeks (short); 26 weeks (moderate) |
Notes |
Conflicts of interest: Not reported
Funding source: Mount Zion Health Fund; Health Resources & Services Administration Fellowship, US Department of Health and Human Services
Other: Information modified for author contact; SDs imputed |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Using blocked, stratified randomisation that was performed after completion of all baseline assessments, participants were randomly assigned. |
Allocation concealment (selection bias) |
Low risk |
Group assignments were made using opaque, sequentially‐numbered, sealed envelopes that contained the group assignment. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Participants were not blinded to which intervention they received. |
Blinding of care provider (performance bias) |
High risk |
Not described |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not described |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Of the 16 subjects undergoing breath therapy, one dropped out after two sessions and was lost to follow‐up. |
Participants analysed in group allocated (attrition bias) |
High risk |
Analyses were performed on all available data in an intention‐to‐treat fashion for 14 subjects in the breath therapy group and 12 subjects in the physical therapy group. |
Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
Groups similar at baseline (selection bias) |
Low risk |
The baseline characteristics of the 28 study subjects were summarised in Table 1. |
Co‐interventions avoided or similar (performance bias) |
Low risk |
Author contact: measured co‐interventions |
Compliance acceptable in all groups (performance bias) |
Low risk |
Author contact: no difference between groups |
Timing of outcome assessment similar in all groups (detection bias) |
Unclear risk |
Support for judgement was not available. |