| Study characteristics |
| Methods |
Study design: RCT (ACTRN012605000262606)
Setting: Australia, healthcare
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 154 (E1 = 77, C1 = 77)
Chronic LBP duration: 330 weeks (long)
Neurological/radicular symptoms: Some participants
Mean age (years): 54
Sex (female): 60% |
| Interventions |
Exercise Group 1 (E1): Two‐stage motor control exercises: 1st stage exercises for retraining multifidus and transversus abdominal muscles, pelvic floor muscles and control of spinal posture and movement with biofeedback; 2nd stage functional tasks and home exercise; type = core strengthening; duration = 8 weeks; dose = low; design = individualised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Placebo: detuned shortwave diathermy and detuned ultrasound |
| Outcomes |
Core outcomes reported: Pain (Numeric Rating Scale); function (Roland‐Morris Disability Questionnaire); Global Perceived Health or Recovery (Global Perceived Health or Recovery (Global Perceived Effect scale))
Follow‐up time periods available for syntheses: 8 weeks (short); 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: Not reported
Funding source: Research & Development Grant, The University of Sydney and the Physiotherapy Research Foundation–Australian Physiotherapy Association
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The randomisation sequence was computer‐generated by one of the investigators. |
| Allocation concealment (selection bias) |
Low risk |
Allocation was concealed in sequentially numbered, sealed, opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The placebo treatment was designed to he structurally equivalent to the active intervention, providing similar contact time with the physical therapist. |
| Blinding of care provider (performance bias) |
High risk |
The nature of the interventions precluded blinding of the treatment provider. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcomes obtained by telephone interview by an investigator who was blinded to the treatment allocation |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Of the 154 participants who were randomly assigned to groups, 152 attended the two‐monthly follow‐up (98.7%) and 145 attended both six‐ and 12‐month follow‐up. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
The statistical analysis was performed on an intention‐to‐treat basis. |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
The characteristics of the participants in the two groups were similar at baseline. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Ten patients from the exercise group and one patient from the placebo group reported use of co‐interventions during the study period. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Out of 12 planned treatment sessions, the participants in the exercise group attended a mean of 8.8 sessions (SD = 3.5) compared with 9.6 sessions (SD = 3). |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
