Study characteristics |
Methods |
Study design: randomized controlled trial
Setting: Abeerden Royal Hospitals Trust, Aberdeen, UK
|
Participants |
Acute/subacute population
Inclusion criteria: patients with an subacute episode of LBP (< 12 weeks duration) and a lateral shift of the lumbosacral spine
Exclusion criteria: patients with chronic back pain or previous spinal surgery and those who needed immediate surgical intervention
N = 40: treatment group = 19; control group = 21
Age range, years: treatment group = 29‐55 (male), 26‐53 (female); control group = 29‐58 (male), 32 to 53 (female)
Sex (N): treatment group = 7 female, 4 male; control group = 6 female, 8 male
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Interventions |
Treatment group: McKenzie method
Control group: non‐specific back massage and standard back care advice
Both groups were treated by the same therapist using a standard protocol and attended 2 or 3 times during the first week and thereafter at the discretion of the therapist.
|
Outcomes |
|
Notes |
Patients were treated by a physiotherapist holding the McKenzie diploma in mechanical diagnosis and therapy |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Patients were randomly allocated, using a list of random numbers, to one of two groups for management". |
Allocation concealment (selection bias) |
High risk |
A list of random numbers was used |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
The index and control groups are distinguishable for the patients. |
Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
The index and control groups are distinguishable for the care providers. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
The primary outcomes are self‐reported outcomes, in which the patient (unblinded) is the outcome assessor. |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
High and not balanced rate of withdrawals for short‐term follow‐up (30% in control group; 40% in McKenzie group, approximately) |
Intention to treat analysis |
High risk |
Patients who withdrawn from the study were excluded from the analysis. |
Selective reporting (reporting bias) |
Unclear risk |
Protocol not available and the report does not include enough information to make this judgement. |
Group similarity at baseline |
Low risk |
There were no important differences among the groups in baseline demographic characteristics or outcome measures. |
Co‐interventions |
Unclear risk |
No information on the text. We attempted to contact the authors, but our attempts were unsuccessful. |
Compliance |
Low risk |
Both groups were attended 2 to 3 sessions during the first week and thereafter at the description of the therapist. |
Timing of outcome assessment |
Low risk |
Patients in both groups were evaluated at same time |
Other bias |
Low risk |
Free of other sources of bias |