The purpose of this study is to assess the efficacy of the McKenzie method in patients with chronic non-specific low back.
One hundred and forty-eight patients will be randomly allocated to two treatment groups: McKenzie method or Placebo (detuned ultrasound and short wave therapy) for 5 weeks (total of 10 sessions of 30 minutes each). The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by constructing mixed linear models.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
The patients allocated to the Placebo group will be treated with detuned pulsed ultrasound therapy for 5 minutes and detuned short wave diathermy in pulsed mode for 25 minutes. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
The patients of the McKenzie group will be treated according to the principles of the method and the choice of therapeutic intervention will be guided by the physical examination findings and classification. Patients will also receive written instructions from the Treat Your Own Back book and will be asked to perform home exercises based on the principles of McKenzie method. The description of the exercises that will be prescribed in this study are already published elsewhere. Compliance with home exercises will be monitored by means of a daily-log that the patient will fill in at home and bring to the therapist at each subsequent session. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
Universidade Cidade de Sao Paulo
São Paulo, São Paulo, Brazil
Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Time frame: 5 weeks after randomization
Disability
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Time frame: Five weeks after randomization
Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Time frame: 3, 6 and 12 months after randomization
Disability
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Time frame: 3, 6 and 12 months after randomization
Function
Disability and function will be measured by an 11-point (0-10) Patient-Specific Functional Scale
Time frame: Five weeks, 3, 6 and 12 months after randomization
Kinesiophobia
Kinesiophobia will be measured by the Tampa Scale of Kinesiophobia by means of 17 questions that deal with pain and intensity of symptoms.
Time frame: Five weeks, 3, 6 and 12 months after randomization
Global perceived effect
Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
Time frame: Five weeks, 3, 6 and 12 months after randomization
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