BACKGROUND: The McKenzie method is widely used as an active intervention in the treatment of patients with non-specific low back pain. Although the McKenzie method has been compared to several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic low back pain. OBJECTIVE: To assess the efficacy of the McKenzie method in patients with chronic non-specific low back pain. DESIGN: Assessor-blinded, 2-arm, randomized, placebo-controlled trial. SETTING: This study will be conducted in physical therapy clinics in Sao Paulo/Brazil. PARTICIPANTS: One hundred and forty-eight patients seeking care for chronic non-specific low back pain. INTERVENTION: Patients will be randomly allocated to two treatment groups: McKenzie method or Placebo (detuned ultrasound and short wave therapy) for 5 weeks of 30 minutes each. MEASUREMENTS: The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The primary outcomes will be pain intensity (measured by the Pain Numerical Scale) and disability (measured by the Roland Morris Disability Questionnaire) at the completion of treatment. The secondary outcomes will be pain intensity, disability and function, kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization and kinesiophobia and global perceived effect at completion of treatment. The data will be collected by a blinded assessor. LIMITATION: Therapists will not be blinded. CONCLUSION: This will be the first trial to compare McKenzie to placebo in patients with chronic non-specific low back pain. The results of this study will contribute to better management of this population.
a1538-6724 (Electronic)