Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of the McKenzie method in patients with chronic non-specific low back.

Detailed Description
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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.

Official Title
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Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial

Conditions
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Non-specific Chronic Low Back Pain

Intervention / Treatment
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* Other: Placebo
* Other: McKenzie method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale, aged between 18 and 80 years and able to read in Portuguese. - Exclusion Criteria: patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The patients allocated to the Placebo group will be treated with detuned pulsed ultrasound 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). | Other: Placebo<br>* 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).<br>* Other names: Nocebo effect;|
| Experimental: McKenzie method<br>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. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). | Other: McKenzie method<br>* 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).<br>* Other names: McKenzie;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) | 5 weeks after randomization | 
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire | Five weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) | 3, 6 and 12 months after randomization | 
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire | 3, 6 and 12 months after randomization | 
| Function | Disability and function will be measured by an 11-point (0-10) Patient-Specific Functional Scale | 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. | 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 | Five weeks, 3, 6 and 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Backache, Lower Back Pain, Lumbago, Low Back Pain, Mechanical Low Back Pain, Low Back Ache