| Study characteristics |
| Methods |
Study design: RCT (NCT01719276)
Setting: Brazil, healthcare
Exercise groups: 2
Comparison groups: 0 |
| Participants |
Number of participants: 66 (E1 = 33, E2 = 33)
Chronic LBP duration: 67 months (long)
Neurological/radicular symptoms: Not specified
Mean age (years): 47
Sex (female): 74% |
| Interventions |
Exercise Group 1 (E1): Graded activity: treadmill for 20 minutes at 70‐80% Max heart rate, strengthening of the legs and back; type = mixed; duration = 6 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = advice/education
Exercise Group 2 (E2): Physiotherapy: stretches and strengthening of arms, legs, and trunk; type = stretching & core strengthening; duration = 6 weeks; dose = low; design = standardised; delivery = individual; additional intervention = none |
| Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Roland‐Morris Disability Questionnaire); work (return to work); HRQoL (36‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Perceived Effect scale))
Follow‐up time periods available for syntheses: 13 weeks (short); 26 weeks (moderate) |
| Notes |
Conflicts of interest: None to declare
Funding source: Not reported
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
A randomisation code was created using Microsoft Excel for Windows software. |
| Allocation concealment (selection bias) |
Low risk |
Randomisation was performed by a researcher who was not involved in the recruitment process; allocation schedule was concealed by using consecutively numbered, sealed, opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of patient blinding caused deviations from the intended interventions because the two treatment groups were so similar |
| 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 the intended interventions because the two treatment groups were so similar |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
1. Outcome assessors for pain and function were the patients themselves, 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. Neither treatment was obviously better than the other; no reason to alter patient response. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. 6 patients out of 66 were lost to follow‐up at the 3‐month follow‐up, 9.1%. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Analyses "were performed on an intention‐to‐treat basis". |
| Selective reporting (reporting bias) |
Low risk |
1. Study was analysed and reported according to registered protocol (NCT01719276). |
| Groups similar at baseline (selection bias) |
Low risk |
Several characteristics were collected and were similar; slightly large difference in duration of symptoms was likely accountable to chance; there was no indication of problematic randomisation. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
"Participants were instructed not to participate in any other intervention during the treatment period. There was no interference in the use of medication". |
| Compliance acceptable in all groups (performance bias) |
Low risk |
"Patients in the physiotherapy exercise attended 91.4% of the sessions, while those in the graded activity group attended 91.9%". |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcome assessments were identical for all patients, regardless of treatment group; 2. Roland‐Morris Disability Questionnaire (for function), and Numeric Rating Scale (for pain) are all well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
