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. 2023 Apr 5;2023(4):CD009711. doi: 10.1002/14651858.CD009711.pub2

Gillan 1998.

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

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
  • Disability (ODI)

  • Timing of assessments: 4 weeks and 3 months

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Intention to treat analysis High risk Patients who withdrawn from the study were excluded from the analysis.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