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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Universidade Cidade de Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luciola da Cunha Menezes Costa, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier:
NCT02123394
First received: April 16, 2014
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Non-specific Chronic Low Back Pain
Other: Placebo
Other: McKenzie method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universidade Cidade de Sao Paulo:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 5 weeks after randomization ] [ Designated as safety issue: No ]
    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  • Disability [ Time Frame: Five weeks after randomization ] [ Designated as safety issue: No ]
    Disability will be measured by the 24-item Roland Morris Disability Questionnaire


Secondary Outcome Measures:
  • Pain Intensity [ Time Frame: 3, 6 and 12 months after randomization ] [ Designated as safety issue: No ]
    Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)

  • Disability [ Time Frame: 3, 6 and 12 months after randomization ] [ Designated as safety issue: No ]
    Disability will be measured by the 24-item Roland Morris Disability Questionnaire

  • Function [ Time Frame: Five weeks, 3, 6 and 12 months after randomization ] [ Designated as safety issue: No ]
    Disability and function will be measured by an 11-point (0-10) Patient-Specific Functional Scale

  • Kinesiophobia [ Time Frame: Five weeks, 3, 6 and 12 months after randomization ] [ Designated as safety issue: No ]
    Kinesiophobia will be measured by the Tampa Scale of Kinesiophobia by means of 17 questions that deal with pain and intensity of symptoms.

  • Global perceived effect [ Time Frame: Five weeks, 3, 6 and 12 months after randomization ] [ Designated as safety issue: No ]
    Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale


Other Outcome Measures:
  • Patient's expectancy for improvement [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Will be assessed by the Expectancy of Improvement Numerical Scale.


Estimated Enrollment: 148
Study Start Date: May 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: McKenzie

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02123394

Contacts
Contact: Leonardo OP Costa, PhD +551121781565 leonardo.costa@unicid.edu.br

Locations
Brazil
Universidade Cidade de Sao Paulo Not yet recruiting
Sao Paulo, SP, Brazil, 03071-000
Contact: Leonardo OP Costa, PhD    551121781565    leonardo.costa@unicid.edu.br   
Sub-Investigator: Luciola CM Costa, PhD         
Sub-Investigator: Alessandra N Garcia, MsC         
Principal Investigator: Leonardo OP Costa, PhD         
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Leonardo OP Costa, PhD Universidade Cidade de São Paulo
Study Director: Luciola CM Costa, PhD Universidade Cidade de São Paulo
  More Information

No publications provided

Responsible Party: Luciola da Cunha Menezes Costa, Associate Professor, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02123394     History of Changes
Other Study ID Numbers: FAPESP200755
Study First Received: April 16, 2014
Last Updated: April 23, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Cidade de Sao Paulo:
Low Back Pain
Mechanical Low Back Pain
Low Back Ache
Low Backache
Lower Back Pain
Lumbago

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014