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

Primary Purpose

Non-specific Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
McKenzie method
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Chronic Low Back Pain focused on measuring Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Universidade Cidade de Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

McKenzie method

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability
Disability will be measured by the 24-item Roland Morris Disability Questionnaire

Secondary Outcome Measures

Pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Disability
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Function
Disability and function will be measured by an 11-point (0-10) Patient-Specific Functional Scale
Kinesiophobia
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
Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Full Information

First Posted
April 16, 2014
Last Updated
June 9, 2016
Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02123394
Brief Title
Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain
Acronym
Mckenzie
Official Title
Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Chronic Low Back Pain
Keywords
Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
McKenzie method
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo effect, Nocebo effect
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
McKenzie method
Other Intervention Name(s)
McKenzie
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)
Time Frame
5 weeks after randomization
Title
Disability
Description
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Time Frame
Five weeks after randomization
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
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
Title
Disability
Description
Disability will be measured by the 24-item Roland Morris Disability Questionnaire
Time Frame
3, 6 and 12 months after randomization
Title
Function
Description
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
Title
Kinesiophobia
Description
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
Title
Global perceived effect
Description
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
Other Pre-specified Outcome Measures:
Title
Patient's expectancy for improvement
Description
Will be assessed by the Expectancy of Improvement Numerical Scale.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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. - 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo OP Costa, PhD
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luciola CM Costa, PhD
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Cidade de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
03071-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
28701365
Citation
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.
Results Reference
derived
PubMed Identifier
25278336
Citation
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.
Results Reference
derived

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

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