| Study characteristics |
| Methods |
Study design: RCT
Setting: USA, healthcare
Exercise groups: 2
Comparison groups: 2 |
| Participants |
Number of participants: 200 (E1 = 50, E2 = 50, C1 = 50, C2 = 50)
Chronic LBP duration: 7.5 years (long)
Neurological/radicular symptoms: Some participants
Mean age (years): 74
Sex (female): 55% |
| Interventions |
Exercise Group 1 (E1): General conditioning (strength and flexibility), aerobic exercise, home exercise (flexibility and walking); type = mixed; duration = 6 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = placebo
Exercise Group 2 (E2): General conditioning (strength and flexibility), aerobic exercise, home exercise (flexibility and walking); type = mixed; duration = 6 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = electrotherapy
Comparison Group 1 (C1): Placebo: sham percutaneous electrical nerve stimulation (PENS) treatment
Comparison Group 2 (C2): Other conservative treatment (electrotherapy) |
| Outcomes |
Core outcomes reported: Pain (McGill Pain Score); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (global change in condition (5‐point))
Follow‐up time periods available for syntheses: 6 weeks (short); 26 weeks (moderate) |
| Notes |
Conflicts of interest: Dr. Perera received funding from Eli Lily & Co. to do observational research
Funding source: National Center for Complementary and Alternative Medicine (Grant R01 AT000985); National Institute on Aging, National Institutes of Health; Pittsburgh Claude D. Pepper Older Americans Independence Center (NIA P30 AG‐024827)
Other: None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Participants were randomised to one of the four groups, using a stratified blocked randomisation scheme and a statistical software for random deviation. |
| Allocation concealment (selection bias) |
High risk |
One of the study investigators created and monitored the implementation of the randomisation scheme. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not described |
| Blinding of care provider (performance bias) |
High risk |
One of the study investigators created and monitored the implementation of the randomisation scheme. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The research associate who collected the outcome data was masked to group assignment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
The overall dropout rate was 8% (Figure 1). |
| Participants analysed in group allocated (attrition bias) |
Low risk |
The analysis was repeated with last‐value‐carried‐forward and multiple imputation approaches to assess sensitivity of the results. |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
There were no significant differences between groups. |
| Co‐interventions avoided or similar (performance bias) |
Unclear risk |
Not described |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Adherence with general conditioning and aerobic exercise was also comparable between groups. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
