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

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

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

Study Overview

• Status: Completed
• Conditions: Non-specific Chronic Low Back Pain
• Intervention / Treatment: Other: Placebo; Other: McKenzie method

Detailed Description

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
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 03071-000
      • Universidade Cidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; 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; 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).; Other Names: Placebo effect; Nocebo effect
EXPERIMENTAL: McKenzie method; 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; 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).; Other Names: McKenzie

What is the study measuring?

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
Disability	Disability will be measured by the 24-item Roland Morris Disability Questionnaire	3, 6 and 12 months after randomization
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's expectancy for improvement	Will be assessed by the Expectancy of Improvement Numerical Scale.	Baseline

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Director: Luciola CM Costa, PhD, Universidade Cidade de Sao Paulo

Publications and helpful links

General Publications

• Garcia AN, Costa LDCM, Hancock MJ, Souza FS, Gomes GVFO, Almeida MO, Costa LOP. McKenzie Method of Mechanical Diagnosis and Therapy was slightly more effective than placebo for pain, but not for disability, in patients with chronic non-specific low back pain: a randomised placebo controlled trial with short and longer term follow-up. Br J Sports Med. 2018 May;52(9):594-600. doi: 10.1136/bjsports-2016-097327. Epub 2017 Jul 12.
• Garcia AN, Costa Lda C, Hancock MJ, de Almeida MO, de Souza FS, Costa LO. Efficacy of the McKenzie method in patients with chronic nonspecific low back pain: a protocol of randomized placebo-controlled trial. Phys Ther. 2015 Feb;95(2):267-73. doi: 10.2522/ptj.20140208. Epub 2014 Oct 2.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (ESTIMATE): April 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Low Back Pain; Lumbago; Mechanical Low Back Pain; Lower Back Pain; Low Back Ache; Low Backache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FAPESP200755