| Study characteristics |
| Methods |
Study design: RCT (ACTRN12609000834257)
Setting: Australia, mixed
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 96 (E1 = 50, C1 = 46)
Chronic LBP duration: 14.03 weeks (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 42
Sex (female): 52% |
| Interventions |
Exercise Group 1 (E1): Individualised functional restoration involving motor control exercises in muscles around the lumbar spine; type = functional restoration & core strengthening; duration = 10 weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education & psychological therapy
Comparison Group 1 (C1): Other conservative treatment (education) |
| Outcomes |
Core outcomes reported: Pain (Numerical Rating Scale); function (Oswestry Disability Index); work (degree of interference at work, low back pain days missed); HRQoL (EuroQol 5D); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Rating of Change Scale))
Follow‐up time periods available for syntheses: 10 weeks (short); 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: JF reported being an employee and equity partner of the primary funding source (LifeCare Health). This funding arrangement was declared in our published trial protocol. No other LifeCare staff or equity partners had any involvement with the conduct of the trial including study design; in the collection, analysis, and interpretation of data; in the writing of this paper; and in the decision to submit the paper for publication. During the trial, five of the authors (AH, LS, AC, MR, SS) were subcontracted to LifeCare Health and were paid for treating participants with low back disorders and other musculoskeletal conditions. In order to minimise any potential for bias, all authors had full access to the study data, while both JF and AC had final responsibility for the decision to submit for publication. Three of the authors (JF, AH and AC) provide practitioner education programmes that cover some of the treatments included in this trial.
Funding source: LifeCare Health
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Block randomisation schedule (random block sizes), stratified for treatment centre using an internet‐based randomisation program |
| Allocation concealment (selection bias) |
Low risk |
Treatment allocation was concealed using an offsite randomisation service which allocated treatment after volunteer consent and enrolment by the researchers. |
| 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 interventions; 2. Experimental intervention not accessible outside of study, any deviations would be to alternate activity sources which was encouraged for the control 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 provider blinding caused deviations from intended interventions; control group had only 2 brief contacts with provider, and there was built‐in latitude to their content. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcomes in question were assessed by the patients who were not blinded to the intervention; 2. Pain and function questionnaires are subjective and are susceptible to being altered by a lack of blinding; 3. Lack of blinding is likely to alter patient response in an inactive versus active treatment study; active treatment here appeared intricate and likely has high expectations surrounding it. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. 7 of 96 were lost to follow‐up at the 10‐week follow‐up. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Intent‐to‐treat analysis was conducted. |
| Selective reporting (reporting bias) |
Low risk |
1. Study results were analysed and reported as described in study protocol (Hahne 2011, STOPS Trial Protocol). |
| Groups similar at baseline (selection bias) |
Low risk |
Treatment groups were all similar at baseline on all relevant characteristics. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
Patients in the control group sought significantly more healthcare co‐intervention than the experimental group, including chiropractic and massage treatments; medication use was not different. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Participants attended a mean (SD) of 17 (05) (out of 2 max, 85%) sessions in the control group and 83 (21) (out of 10 max, 83%) sessions in the experimental group. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
1. Outcome assessments were identical among all patients, regardless of treatment group; 2. Numeric Rating Scale (for pain) and Oswestry Disability Index (for function) are well‐validated tools in the low back pain context. |
| Other bias |
Low risk |
Appeared free from other sources of bias |
