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Completed

NCT Number: NCT02123394

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

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

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Key information

Conditions

Non-specific Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Cidade de Sao Paulo

São Paulo, 03071-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Placebo

Other

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

McKenzie method

Other

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

Primary outcomes

  1. Pain Intensity

    Time frame: 5 weeks after randomization

    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: Five weeks after randomization

    Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Secondary outcomes

  1. Pain Intensity

    Time frame: 3, 6 and 12 months after randomization

    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  2. Disability

    Time frame: 3, 6 and 12 months after randomization

    Disability will be measured by the 24-item Roland Morris Disability Questionnaire

  3. Function

    Time frame: Five weeks, 3, 6 and 12 months after randomization

    Disability and function will be measured by an 11-point (0-10) Patient-Specific Functional Scale

  4. Kinesiophobia

    Time frame: Five weeks, 3, 6 and 12 months after randomization

    Kinesiophobia will be measured by the Tampa Scale of Kinesiophobia by means of 17 questions that deal with pain and intensity of symptoms.

  5. Global perceived effect

    Time frame: Five weeks, 3, 6 and 12 months after randomization

    Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Other outcomes

  1. Patient's expectancy for improvement

    Time frame: Baseline

    Will be assessed by the Expectancy of Improvement Numerical Scale.

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: Mckenzie

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 25, 2014
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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