| Study characteristics |
| Methods |
Study design: RCT (NCT02327325)
Setting: USA, healthcare
Exercise groups: 2
Comparison groups: 1 |
| Participants |
Number of participants: 60 (E1 = 20, E2 = 20, C1 = 20)
Chronic LBP duration: 5 years (long)
Neurological/radicular symptoms: Not specified
Mean age (years): 70
Sex (female): 7% |
| Interventions |
Exercise Group 1 (E1): Physical activity (core strengthening, stretching and aerobics), instructions for at‐home exercise programme; type = mixed; duration = 12 weeks; dose = low; design = partially individualised; delivery = independent; additional intervention = psychological therapy
Exercise Group 2 (E2): Physical activity: instructions for at‐home exercise programme (written instructions with pictures, exercise video, physiotherapist instructions). Exercises included core strengthening, stretching and aerobics; type = mixed; duration = 12 weeks; dose = low; design = partially individualised; delivery = independent; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (waiting‐list group) |
| Outcomes |
Core outcomes reported: Function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 12 weeks (short) |
| Notes |
Conflicts of interest: S. Taylor reported employment/money received from the Department of Veterans Affairs, Health Services Research & Development.
Funding source: Department of Veterans Affairs Rehabilitation and Research Development (1I21RX001569‐ 01A1); Center of Innovation for Health Services Research in Primary Care (CIN 13‐410), Durham Veteran's Affairs Health Care System
Other: SDs imputed; 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 |
Participants were randomised by use of a computer‐generated randomisation table programmed into the study tracking database; participants were randomised with equal allocation to 1 of 3 study arms. |
| Allocation concealment (selection bias) |
High risk |
No information reported about whether or not treatment allocation was concealed until delivery to participant |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded due to the nature of the treatments;2. Unlikely that lack of patient blinding caused significant deviation from intended intervention, as they all required instruction from a trained facilitator (except waiting‐list group) |
| Blinding of care provider (performance bias) |
Low risk |
1. Care providers could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of care provider blinding caused deviations from intended intervention; the only significant interaction participants had beyond baseline was in the CBT group. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcome assessor for outcome of interest (disability) were participants, who could not be blinded due to the nature of the treatments; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. There were clear degrees of intervention complexity and rank of "trendiness"; likely to alter assessment. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. 10 of 60 withdrew, 17%. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Appeared safe to assume that intention‐to‐treat analysis was conducted |
| Selective reporting (reporting bias) |
Low risk |
1. No published protocol, but all analyses were performed and reported as described in methods. |
| Groups similar at baseline (selection bias) |
Low risk |
Most characteristics were similar at baseline among treatment groups; marriage status, education; every important characteristic was measured and reported. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
No information was reported about co‐interventions during the treatment period; somewhat unlikely that waiting‐list patients did not use any co‐interventions |
| Compliance acceptable in all groups (performance bias) |
High risk |
No compliance information was reported; patients followed up by telephone weekly, but no report on reported physical activity completion, unlikely that compliance was very high (unsupervised, home‐based exercise) |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Within each outcome, all participants were measured with the same tools, thresholds and at the same time point; 2. Roland‐Morris Disability Questionnaire is a well‐validated tool for measuring disability in the context of low back pain. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
