Mckenzie Extension Exercise Reduce Chronic Low Back Pain a Systematic Review
Background
The McKenzie method is widely used as an agile intervention in the treatment of patients with nonspecific low back pain. Although the McKenzie method has been compared with several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic depression back pain.
Objective
The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain.
Design
An assessor-blinded, two-arm, randomized placebo-controlled trial will be conducted.
Setting
This study volition exist conducted in physical therapy clinics in São Paulo, Brazil.
Participants
The participants will be 148 patients seeking treat chronic nonspecific depression back pain.
Intervention
Participants will be randomly allocated to 1 of 2 handling groups: (ane) McKenzie method or (2) placebo therapy (detuned ultrasound and shortwave therapy). Each group will receive ten sessions of thirty minutes each (two sessions per week over v weeks).
Measurements
The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The main outcomes will be pain intensity (measured with the Pain Numerical Rating Scale) and disability (measured with the Roland-Morris Inability Questionnaire) at the completion of treatment. The secondary outcomes will exist pain intensity; disability and function; kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization; and kinesiophobia and global perceived result at completion of treatment. The data will be collected by a blinded assessor.
Limitations
Therapists will non exist blinded.
Conclusions
This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back hurting. The results of this written report will contribute to better direction of this population.
Depression back pain is a major wellness condition associated with a high rate of absenteeism from work and a more frequent utilise of health services and piece of work leave entitlements. one Low dorsum pain recently was rated by the Global Burden of Illness Study as i of the 7 health weather that most bear on the world'southward population, ii and it is considered a debilitating health condition that affects the population for the greatest number of years over a lifetime. 2 The betoken prevalence of low back pain in the general population is reported to be upward to 18%, increasing to 31% in the last xxx days, 38% in the last 12 months, and 39% at whatsoever bespeak in life. 3 Low back pain besides is associated with high treatment costs. 4 It is estimated that in European countries, the direct and indirect costs vary from €ii to €4 billion a year. 4 The prognosis of low back hurting is directly related to the duration of the symptoms. 5,6 Patients with chronic low dorsum pain have a less favorable prognosis compared with patients with acute low back pain v,7 and are responsible for most of the costs for management of back pain, generating the demand for research aimed at finding improve treatments for these patients.
There is a peachy diversity of interventions for the treatment of patients with chronic low back pain, including the McKenzie method developed by Robin McKenzie in New Zealand in 1981. viii The McKenzie method (as well known as Mechanical Diagnosis and Therapy [MDT]) is an active therapy that involves repeated movements or sustained positions and has an educational component with the purpose of minimizing hurting and disability and improving spinal mobility. 8 The McKenzie method involves the assessment of symptomatic and mechanical responses to repeated movements and sustained positions. Patients' responses to this assessment are used to allocate them into subgroups or syndromes called derangement, dysfunction, and posture. eight–10 Nomenclature according to i of these groups guides the treatment principles.
Derangement syndrome is the largest group and characterized by patients who demonstrate centralization (transition of pain from distal to proximal) or disappearance of pain 11 with repeated movement testing in 1 direction. These patients are treated with repeated movements or sustained positions that could reduce pain. Patients classified as having dysfunction syndrome are characterized by pain that occurs but at the end of the range of motion of merely 1 motility. 8 The hurting does not change or centralize with repeated movement testing. The treatment principle for patients with dysfunction is repeated movements in the management that generated the pain. Finally, patients classified as having postural syndrome experience intermittent pain merely during sustained positioning at the end of the range of motion (eg, sustained slumped sitting). 8 The handling principle for this syndrome consists of posture correction. 11
The McKenzie method too includes a strong educational component based on the books titled The Lumbar Spine: Mechanical Diagnosis & Therapy: Volume Two 11 and Care for Your Own Back. 12 This method, different other therapeutic methods, aims to make the patients as independent of the therapist as possible and thus capable of controlling their hurting through postural intendance and the practice of specific exercises for their problem. 11 It encourages patients to motility the spine in the direction that is non harmful to their problem, thus avoiding movement restriction due to kinesiophobia or hurting. 11
Two previous systematic reviews have analyzed the effects of the McKenzie method 9,10 in patients with acute, subacute, and chronic low back pain. The review past Clare et al 9 demonstrated that the McKenzie method showed better results in short-term pain relief and improvement of inability compared with agile interventions such every bit physical exercise. The review by Machado et al 10 showed that the McKenzie method reduced hurting and disability in the curt term when compared with passive therapy for acute low dorsum pain. For chronic low back pain, the two reviews were unable to depict conclusions about the effectiveness of the McKenzie method due to the lack of appropriate trials. The randomized controlled trials that have investigated the McKenzie method in patients with chronic low dorsum pain 13–17 compared the method with other interventions such equally resistance training, 17 the Williams method, 14 unsupervised exercises, 16 body strengthening, 15 and stabilization exercises. 13 Better results in reducing pain intensity were obtained with the McKenzie method compared with resistance grooming, 17 the Williams method, 14 and supervised practice. 16 Even so, the methodological quality of these trials 13–17 is suboptimal.
Information technology is known from the literature that the McKenzie method yields beneficial results when compared with some clinical interventions in patients with chronic low dorsum pain; however, to engagement, no studies accept compared the McKenzie method confronting a placebo handling in club to place its actual efficacy. Clare et al 9 highlighted the need to compare the McKenzie method with placebo therapy and to study the effects of the method in the long term. In other words, information technology is not known whether the positive effects of the McKenzie method are due to its existent efficacy or simply to a placebo effect.
The objective of this report will be to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain using a loftier-quality randomized placebo-controlled trial.
Method
Study Design
This volition be an assessor-blinded, ii-arm, randomized placebo-controlled trial.
Study Setting
This report will be conducted in physical therapy clinics in São Paulo, Brazil.
Eligibility Criteria
The written report volition include patients seeking care for chronic nonspecific 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 three months 18), with a pain intensity of at to the lowest degree 3 points every bit measured with the 0- to 10-signal Pain Numerical Rating Calibration, aged between eighteen and 80 years, and able to read Portuguese. Patients volition be excluded if they accept any contraindication to physical exercise 19 or ultrasound or shortwave therapy, evidence of nerve root compromise (ie, ane or more motor, reflex, or sensation deficits), serious spinal pathology (eg, fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery, or pregnancy.
Procedure
Outset, the patients will be interviewed by the study'south blinded assessor, who will determine eligibility. Eligible patients volition exist informed almost the objectives of the study and asked to sign a consent course. Next, the patient'due south sociodemographic data and medical history volition be recorded. The assessor will then collect the data related to the study outcomes at the baseline assessment, afterwards completion of 5 weeks of treatment, and iii, half dozen, and 12 months after randomization. With the exception of baseline measurements, all other assessments will be collected over the telephone. All information entry will be coded, entered into an Excel (Microsoft Corporation, Redmond, Washington) spreadsheet, and double-checked prior to the analysis.
Upshot Measures
The clinical outcomes volition exist measured at the baseline assessment, after treatment, and 3, 6, and 12 months subsequently random allotment. The primary outcomes will be hurting intensity (measured with the Hurting Numerical Rating Scale) 20 and disability (measured with the Roland-Morris Disability Questionnaire) 21,22 after completion of 5 weeks of handling. The secondary outcomes will exist pain intensity and disability three, half dozen, and 12 months later randomization and disability and function (measured by the Patient-Specific Functional Scale), 20 kinesiophobia (measured with the Tampa Scale of Kinesiophobia), 23 and global perceived effect (measured with the Global Perceived Consequence Calibration) 20 after treatment and 3, half dozen, and 12 months after randomization. On the day of the baseline assessment, each patient's expectancy for improvement also volition exist assessed using the Expectancy of Comeback Numerical Scale, 24 followed by assessment using the McKenzie method. 8 Patients may experience an exacerbation of symptoms after the baseline cess due to the MDT physical test. All measurements were previously cross-culturally adapted into Portuguese and clinimetrically tested and are described below.
Pain Numerical Rating Scale
The Pain Numerical Rating Scale is a scale that assesses the levels of pain intensity perceived past the patient using an 11-point calibration (varying from 0 to 10), in which 0 represents "no hurting" and 10 represents the "worst possible hurting." 20 The participants will be instructed to select the average of pain intensity based on the final 7 days.
Roland-Morris Disability Questionnaire
This questionnaire consists of 24 items that draw daily activities that patients have difficulty performing due to low back pain. 21,22 The higher the number of affirmative answers, the higher the level of disability associated with depression back pain. 21,22 The participants will be instructed to complete the questionnaire based on the final 24 hours.
Patient-Specific Functional Scale
The Patient-Specific Functional Scale is a global scale; therefore, it can be used for whatever part of the body. 25,26 The patients will be asked to identify upwards to 3 activities that they feel unable to perform or that they have difficulty performing due to their low back hurting. 25,26 Measurement volition exist taken using Likert-type, eleven-indicate scales for each activeness, with higher average scores (ranging from 0 to 10 points) representing amend ability to perform the tasks. 25,26 We will summate the average of these activities based on the terminal 24 hours, with a terminal score ranging from 0 to 10.
Global Perceived Event Scale
The Global Perceived Event Scale is a Likert-type, xi-bespeak scale (ranging from −five to +5) that compares the patient's current condition with his or her condition at the onset of symptoms. xx Positive scores apply to patients who are better and negative scores use to patients who are worse in relation to the onset of symptoms. 20
Tampa Scale of Kinesiophobia
This calibration assesses the level of kinesiophobia (fear of moving) by means of 17 questions that deal with pain and intensity of symptoms. 23 The scores from each item vary from one to four points (eg, 1 point for "strongly disagree," ii points for "partially disagree," 3 points for "concord," and 4 points for "strongly agree"). 23 For the total score, it is necessary to invert the scores of questions 4, 8, 12, and sixteen. 23 The final score can vary from 17 to 68 points, with higher scores representing a college degree of kinesiophobia. 23
Expectancy of Improvement Numerical Scale
This scale assesses the patient's expectancy for improvement after treatment in human relationship to a specific handling. 24 Information technology consists of an 11-point calibration varying from 0 to 10, in which 0 represents "no expectancy for improvement" and 10 represents "expectancy for the greatest possible improvement." 24 This scale will exist administered just on the get-go twenty-four hours of assessment (baseline) earlier the randomization. The reason for including this calibration is to analyze whether the expectation of comeback will influence the outcomes.
Random Allotment
Earlier the treatment begins, the patients will be randomly allocated to their respective intervention groups. The random allocation sequence volition be implemented by one of the researchers not involved with recruiting and assessing the patients and will be generated on Microsoft Excel 2010 software. This random resource allotment sequence will be inserted into sequentially numbered, opaque, sealed envelopes (to ensure that allotment is concealed from the assessor). The envelopes will be opened by the physical therapist who will care for the patients.
Blinding
Given the nature of the written report, it is non possible to bullheaded the therapists to the atmospheric condition of treatment; nevertheless, the assessor and the patients will be blinded to the handling groups. At the end of the written report, the assessor volition be asked whether the patients were allocated to the existent treatment group or to the placebo grouping in order to measure assessor blinding. A visual representation of the study pattern is presented in the Figure.
Figure
Flow diagram of the report.
Figure
Catamenia diagram of the report.
Interventions
The participants will be allocated to groups receiving ane of 2 interventions: (1) placebo therapy or (2) MDT. Participants in each group will receive 10 sessions of 30 minutes each (two sessions per week over v weeks). The studies on the McKenzie method do not accept a standard number of sessions given that some studies propose low doses of treatment, 16,17,27 and others recommend higher doses. 13,15
For ethical reasons, on the start day of handling, patients from both groups will receive an information booklet called The Back Book, 28 based on the same recommendations as the existing guidelines. 29,xxx This booklet volition exist translated into Portuguese so that information technology tin can be completely understood by the study's participants, who will receive additional explanations regarding the content of the booklet, if needed. Patients will be asked in each session if they have felt any different symptom. The principal investigator of the written report will periodically audit the interventions.
Placebo Group
The patients allocated to the placebo group will be treated with detuned pulsed ultrasound for 5 minutes and detuned shortwave diathermy in pulsed way for 25 minutes. The devices volition be used with the internal cables asunder to obtain the placebo effect; all the same, it will be possible to handle them and adjust doses and alarms as if they were continued to simulate the pragmatism of clinical do as well every bit to increment brownie of utilise of these devices on the patients. This technique has been used successfully in previous trials with patients with low back hurting. 31–35
McKenzie Group
The patients of the McKenzie group volition exist treated according to the principles of the McKenzie method, eight and the choice of therapeutic intervention will exist guided by the physical examination findings and classification. Patients also will receive written instructions from the Care for Your Own Back 12 book and volition be asked to perform home exercises based on the principles of McKenzie method. 11 The descriptions of the exercises that volition be prescribed in this study are published elsewhere. 27 Adherence to home exercises will be monitored by ways of a daily log that the patient will fill in at home and bring to the therapist at each subsequent session.
Statistical Methods
Sample size calculation
The study was designed to discover a difference of 1 indicate in hurting intensity measured with the Pain Numerical Rating Calibration 20 (estimate for standard deviation=ane.84 points) 31 and a difference of 4 points in disability associated with low back hurting measured with the Roland-Morris Disability Questionnaire 21,22 (estimate for standard difference=4.nine points). 31 The following specifications were considered: statistical power of lxxx%, alpha level of five%, and follow-upwardly loss of 15%. Therefore, the study will require a sample of 74 patients per group (148 in full).
Analysis of the effects of treatment
The statistical analysis of our study volition follow intention-to-treat principles. 36 The normality of the data will be tested past visual inspection of histograms, and the label of the participants will exist calculated using descriptive statistical tests. The between-group differences (furnishings of treatment) and their respective 95% confidence intervals will exist calculated by constructing mixed linear models 37 using interaction terms of treatment groups versus time. We volition conduct a secondary exploratory analysis to assess whether patients classified equally having derangement syndrome have a better response to the McKenzie method (compared with placebo) than those with other classifications. For this assessment, nosotros will use a 3-manner interaction for group, fourth dimension, and nomenclature. For all of these analyses, nosotros will use the IBM SPSS software package, version 19 (IBM Corp, Armonk, New York).
Ethics
This study was approved by the Research Ethics Committee of the Universidade Cidade de São Paulo (#480.754) and prospectively registered at ClinicalTrials.gov (NCT02123394). Any protocol modifications will be reported to the Research Ethics Commission as well every bit to the trial registry.
Discussion
Potential Impact and Significance of the Written report
The existing randomized controlled trials investigating the McKenzie method in patients with chronic depression dorsum pain have all used an alternative intervention as the comparison grouping. 14–17 To appointment, no report has compared the McKenzie method with a placebo handling in patients with low back hurting in guild to identify its real efficacy, which is an of import gap in the literature. 9 Estimation of the previous comparative effectiveness studies is limited past the lack of knowledge of the efficacy of the McKenzie method for people with chronic low back hurting. This written report will be the first to compare McKenzie method with placebo therapy in patients with chronic nonspecific low dorsum pain. A proper comparison against a placebo grouping volition provide more unbiased estimates of the effects of this intervention. This blazon of comparison has already been done in trials aiming to assess the efficacy of motor control exercises for patients with chronic low back hurting, 31 spinal manipulative therapy and diclofenac for patients with acute low back pain, 38 and practice and communication for patients with subacute low back hurting. 39
Contribution to the Physical Therapy Profession and for Patients
The McKenzie method is one of the few methods used in physical therapy that advocates for the independence of patients. viii,12 This method as well provides patients with tools to promote their autonomy in managing the current pain and even futurity recurrences. 12 Nosotros expect that patients treated with the McKenzie method will benefit more than the patients treated with the placebo treatment. If this hypothesis is confirmed in our report, the results will contribute to meliorate clinical decision making of concrete therapists. Moreover, the arroyo has the potential to reduce the burden associated with the recurrent nature of depression back pain if patients tin can improve self-manage future episodes.
Strengths and Weaknesses of the Study
This trial contemplates a substantial number of patients to minimize bias, and it was prospectively registered. We will utilize true randomization, concealed resource allotment, blinded assessment, and an intention-to-treat assay. The treatments will be conducted by two therapists who were extensively trained to perform the interventions. Nosotros volition monitor the dwelling exercise program. Unfortunately, due to the interventions, we will non be able to blind the therapists to the treatment resource allotment. It is known from the literature that the McKenzie method yields beneficial results when compared with some clinical interventions in patients with chronic depression back pain. xiv–17 To date, however, no studies have compared the McKenzie method with a placebo treatment in society to identify its bodily efficacy.
Time to come Research
The intention of this study group is to submit the results of this written report to a top-level, international peer-reviewed periodical. These published results may provide a basis for time to come trials that investigate the effectiveness of the McKenzie method when delivered at dissimilar doses (different numbers of sets, repetitions, and sessions), which is withal unclear in the literature. Our secondary exploratory analysis aims to assess whether patients classified as having derangement syndrome accept a amend response to the McKenzie method (compared with placebo treatment) than those with other classifications. This cess volition contribute to a ameliorate understanding of possible subgroups of patients with chronic low back hurting who reply all-time to specific interventions. This is an important effect, as exploring subgroups is currently considered the most important research priority in the field of depression dorsum hurting. 40
This study was fully funded by São Paulo Enquiry Foundation (FAPESP) (grant number 2013/20075-v). Ms Garcia is funded past a scholarship from the Coordination for the Improvement of College Education Personnel/Brazilian Government (CAPES/Brazil).
The study was prospectively registered at ClinicalTrials.gov (trial registration: NCT02123394).
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Author notes
All authors provided concept/idea/enquiry design and writing. Mr de Almeida and Mr de Souza provided data drove, participants, and facilities/equipment. Dr 50.O.P. Costa provided data analysis and institutional liaisons. Ms Garcia and Dr L.O.P. Costa provided projection management. Dr 50.C.Yard. Costa provided fund procurement. Ms Garcia and Dr L.C.One thousand. Costa provided consultation (including review of the manuscript before submission). The authors thank Research Foundation of São Paulo (FAPESP) (grant number 2013/20075-five) for funding the study.
© 2015 American Concrete Therapy Association
Source: https://academic.oup.com/ptj/article/95/2/267/2684157
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