TITLE: A Comparison of the Effects of Pilates and McKenzie Training on Pain and General Health in Men with Chronic Low Back Pain: A Randomized Trial

  ABSTRACT.BACKGROUND:
Today, chronic low back pain is one of the special challenges in healthcare. There is no unique approach to treat chronic low back pain. A variety of methods are used for the treatment of low back pain, but the effects of these methods have not yet been investigated adequately.

ABSTRACT.AIM:
The aim of this study was to compare the effects of Pilates and McKenzie training on pain and general health of men with chronic low back pain.

ABSTRACT.MATERIALS AND METHODS:
Thirty-six patients with chronic low back pain were chosen voluntarily and assigned to three groups of 12 each: McKenzie group, Pilates group, and control group. The Pilates group participated in 1-h exercise sessions, three sessions a week for 6 weeks. McKenzie group performed workouts 1 h a day for 20 days. The control group underwent no treatment. The general health of all participants was measured by the General Health Questionnaire 28 and pain by the McGill Pain Questionnaire.

ABSTRACT.RESULTS:
After therapeutic exercises, there was no significant difference between Pilates and McKenzie groups in pain relief (P = 0.327). Neither of the two methods was superior over the other for pain relief. However, there was a significant difference in general health indexes between Pilates and McKenzie groups.

ABSTRACT.CONCLUSION:
Pilates and McKenzie training reduced pain in patients with chronic low back pain, but the Pilates training was more effective to improve general health.

BODY.I:
Low back pain with a history of more than 3 months and without any pathological symptom is called chronic low back pain. For patient with chronic low back pain, the physician should take into consideration the likelihood of muscle pain development with spinal origin, in addition to low back pain with unknown origin. This type of pain may be mechanical (increase in pain with movement or physical pressure) or nonmechanical (increase in pain at the rest time).[1] Low back pain or spine pain is the most common musculoskeletal complication.[2] About 50%–80% of healthy people may experience low back pain during their lifetime, and about 80% of the problems are related to the spine and occur in the lumbar area.[3] Low back pain may be caused by trauma, infection, tumors, etc.[4] Mechanical injuries which are caused by overuse of a natural structure, deformity of an anatomical structure, or the injury in the soft tissue are the most common reasons for back pain. From occupational health perspective, back pain is among the most important reasons for the absence from work and occupational disability;[5] in fact, the longer the period of disease,[6] the less likely it is to improve and return to work.[1] Disability due to low back pain in addition to disturbance in doing daily and social activities has a very negative effect, from social and economic perspectives, on the patient and the community, which makes chronic low back pain highly important.[3] Today, chronic low back pain is one of the critical challenges in medicine. Patients with chronic low back pain are responsible for 80% of the costs paid for the treatment of low back pain that is also the reason for mobility restrictions in most people under 45 years.[7] In the developed countries, the overall cost paid for low back pain per year is 7.1 of total share of the gross national product. Clearly, most of the cost is related to counseling and treatment of patients with chronic low back pain rather than with intermittent and recursive low back pain.[8] The existence of various methods of treatment is because of no single cause of low back pain.[9] A variety of methods such as pharmacotherapy, acupuncture, infusions, and physical methods are the most common interventions for treatment of low back pain. However, the effects of these methods remain to be fully known.[6] An exercise program, developed based on the physical conditions of patients, can promote the quality of life in patients with chronic disease.[1011121314]  Literature shows that the effect of exercise in controlling chronic low back pain is under study and there is strong evidence about the fact that movement therapy is effective to treat low back pain.[15] However, no specific recommendations exist about the type of exercise, and the effects of certain types of movement therapies have been determined in few studies.[9] Pilates training consists of the exercises that focus on improving flexibility and strength in all the body organs, without increasing the mass of muscles or destroying them. This training method consists of controlled movements that form a physical harmony between the body and brain, and can raise the ability of the body of people at any age.[16] In addition, people who do Pilates exercise would have better sleep and less fatigue, stress, and nervousness. This training method is based on standing, sitting, and lying positions, without intervals, jumping, and leaping; thus, it may reduce injuries resulting from the joint damage because the exercise movements in the ranges of motion in the above three positions are performed with deep breathing and muscle contraction.[17] McKenzie method, also called mechanical diagnosis and therapy and based on the patient's active participation, is used and trusted by patients and the people who use this method worldwide. This method is based on physical therapy which has been frequently studied. The distinctive characteristic of this method is the principle of initial assessment.[18] This principle is a reliable and safe method to make a diagnosis that makes the correct treatment planning possible. In this way, the time and energy are not spent for costly tests, rather McKenzie therapists, using a valid indicator, quickly recognize that how much and how this method is fruitful for the patient. More appropriately, McKenzie method is a comprehensive approach based on the correct principles whose full understanding and following is very fruitful.[19] In the recent years, nonpharmacological approaches have attracted the attention of physicians and patients with low back pain.[20] Complementary therapies[21] and treatments with holistic nature (to increase physical and mental well-being) are appropriate to manage physical illness.[13] Complementary therapies can slow down disease progression and improve capacity and physical performance. The aim of the present study is to compare the effect of the Pilates and McKenzie training on pain and general health in men with chronic low back pain.

BODY.M:
This randomized clinical trial was conducted in Shahrekord, Iran. The total study population screened was 144. We decided to enroll at least 25% of the population, 36 individuals, using a systematic random sampling. First, the participants were numbered and a list was developed. The first case was selected using random number table and then one out of four patients was randomly enrolled. This process continued till a desired number of participants were enrolled. Then, the participants were randomly assigned to experimental (Pilates and McKenzie training) groups and control group. After explaining the research purposes to the participants, they were asked to complete the consent form for participation in the study. Furthermore, the patients were ensured that the research data are kept confidential and used only for research purposes.

BODY.M.INCLUSION CRITERIA:
The study population included men aged 40–55 years in Shahrekord, South-West Iran, with chronic back pain, that is, history of more than 3 months of low back pain and no specific disease or other surgery.

BODY.M.EXCLUSION CRITERIA:
The exclusion criteria were low back arch or so-called army back, serious spinal pathology such as tumors, fractures, inflammatory diseases, previous spinal surgery, nerve root compromise in the lumbar region, spondylolysis or spondylolisthesis, spinal stenosis, neurological disorders, systemic diseases, cardiovascular diseases, and receiving other therapies simultaneously. The examiner who assessed the outcomes was blinded to group assignment. Twenty-four hours before the training, a pretest was administered to all three groups to determine pain and general health; and then, the training began after completion of the McGill Pain Questionnaire (MPQ) and the General Health Questionnaire-28 (GHQ-28). The MPQ can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. Minimum pain score: 0 (would not be seen in a person with true pain), maximum pain score: 78, and the higher the pain score the more severe the pain. Investigators reported that the construct validity and the reliability of the MPQ were reported as a test-retest reliability of 0.70.[22] The GHQ is a self-administered screening questionnaire. Test-retest reliability has been reported to be high (0.78–0 0.9) and inter- and intra-rater reliability have both been shown to be excellent (Cronbach's α 0.9–0.95). High internal consistency has also been reported. The lower the score is, the better the general health is.[23]  The participants in the experimental groups started training program under supervision of a sports medicine specialist. The training program consisted of 18 sessions of supervised individual training for both groups, with the sessions held three times per week for 6 weeks. Each training session lasted for an hour and was performed at the Physiotherapy Clinic in the School of Rehabilitation of the Shahrekord University of Medical Sciences in 2014–2015. The first experimental group performed Pilates training for 6 weeks, three times a week about an hour per session. In each session, first, a 5-min warm-up and preparation procedures were run; and at the end, stretching and walking were done to return to the baseline condition. In the McKenzie group, six exercises were used: Four extension-type exercises and two flexion-types. The extension-type exercises were performed in prone and standing positions, and the flexion-type exercises in the supine and sitting positions. Each exercise was run ten times. In addition, the participants conducted twenty daily individual training sessions for an hour.[18] After training of both groups, the participants filled out the questionnaires and then the collected data were presented in both descriptive and inferential statistics. Furthermore, the control group without any training, at the end of a period when other groups have completed, filled the questionnaire. Descriptive statistics were used for central tendency indicators such as mean (± standard deviation) and relevant diagrams were used to describe the data. Inferential statistics, one-way ANOVA and post hoc Tukey's test, were used to analyze the data. Data analysis was done by SPSS Statistics for Windows, Version 21.0 (IBM Corp. Released 2012. IBM Armonk, NY: IBM Corp). P < 0.05 was considered statistically significant.

BODY.R:
The results showed no significant difference between the case and control groups regarding the gender, marital status, job, educational level, and income. The results showed changes in pain index and general health in the participants before and after Pilates and McKenzie training in the two experimental and even control groups [Table 1].   Table 1 Mean indexes of the participants before and after intervention   A significant difference was seen in pain and general health between the control and the two experimental groups at the pre- and post-test, so that the exercise training (both Pilates and McKenzie) resulted in reduced pain and promoted general health; while in the control group, pain increased and general health declined.

BODY.D:
The results of this study indicate that back pain reduced and general health enhanced after exercise therapy with both Pilates and McKenzie training, but in the control group, pain was intensified. Petersen et al. study on 360 patients with chronic low back pain concluded that at the end of 8 weeks of McKenzie training and high-intensity endurance training and 2 months training at home, pain and disability decreased in McKenzie group at the end of 2 months, but at the end of 8 months, no differences were seen among the treatments.[24]  The results of another study show that McKenzie training is a beneficial method for reducing pain and increasing the movements of the spine in patients with chronic low back pain.[18] Pilates training can be an effective method for improving general health, athletic performance, proprioception, and reduction of pain in patients with chronic low back pain.[25] The improvements in strength seen in the participants in the present study were more likely to be due to decrease in pain inhibition than to neurological changes in muscle firing/recruitment patterns or to morphological (hypertrophic) changes in the muscle. In addition, neither of the treatments was superior over the other in view of reducing the intensity of pain. In the present study, 6 weeks of McKenzie training led to significant reduction in pain levels in men with chronic low back pain. The rehabilitation of patients with chronic low back pain is aimed to restore strength, endurance, and flexibility of soft tissues.  Udermann et al. showed that McKenzie training improved pain, disability, and psychosocial variables in patients with chronic low back pain, and back stretching training did not have any additional effect on pain, disability, and psychosocial variables.[26] The results of another study show that there is a reduction in pain and disability due to McKenzie method for at least 1 week in comparison with the passive treatment in patients with low back pain, but reduction in pain and disability due to McKenzie method in comparison with the active treatment methods is desirable within 12 weeks after treatment. Overall, McKenzie treatment is more effective than passive methods to treat low back pain.[27] One of the popular exercise therapies for patients with low back pain is McKenzie training program. McKenzie method leads to improvement of low back pain symptoms such as pain in the short-term. Moreover, McKenzie therapy is more effective in comparison with passive treatments. This training is designed to mobilize the spine and to strengthen the lumbar muscles. Previous studies have shown that weakness and atrophy in the body central muscles, particularly the transverse abdominal muscle in patients with low back pain.[28] The results of this research also showed that there was a significant difference in the general health indexes between Pilates and McKenzie groups. In the present study, 6 weeks of Pilates and McKenzie training led to a significant reduction in the level of general health (physical symptoms, anxiety, social dysfunction, and depression) in men with chronic low back pain and the general health in Pilates training group improved. The results of most studies show that exercise therapy reduces pain and improves general health in patients with chronic low back pain. Importantly, the agreement about the duration, type, and intensity of the training remains to be achieved and there is no definite training program that can have the best effect on patients with chronic low back pain. Therefore, more research is needed to determine the best duration and treatment method to reduce and improve general health in patients with low back pain. In the Al-Obaidi et al. study, pain, fear, and functional disability improved after 10 weeks of treatment in patients.[5]  Besides that McKenzie training increases the range of motion of lumbar flexion. Overall, neither of the two methods of treatment was superior over the other.[18]  Borges et al. concluded that after 6 weeks of treatment, the average index of pain in experimental group was lower than the control group. Furthermore, the general health of the experimental group exhibited greater improvement than the control group. The results of this research support recommending Pilates training to patients with chronic low back pain.[29] Caldwell et al. on the university students concluded that Pilates training and Tai chi guan improved mental parameters such as self-sufficiency, quality of sleep, and morality of students but had no effect on physical performance.[30] Garcia et al. study on 148 patients with nonspecific chronic low back pain concluded that treating patients with nonspecific chronic low back pain by McKenzie training and back school caused disability to improve after treatment, but quality of life, pain, and the range of motor flexibility did not change. McKenzie treatment is typically more effective on disability than back school program.[19]  The overall findings of this study are supported by the literature, demonstrating that a Pilates program may offer a low-cost, safe alternative to the treatment of low back pain in this specific group of patients. Similar effects have been found in patients with unspecific chronic low back pain.[31]  Our study had good levels of internal and external validity and thus can guide therapists and patients considering therapies of choice for back pain. The trial included a number of features to minimize bias such as prospectively registering and following a published protocol.

BODY.D.STUDY LIMITATION:
Small sample size enrolled in this study limits the generalization of the study findings.

BODY.C:
The results of this study showed that 6-week Pilates and McKenzie training reduced pain in patients with chronic low back pain, but there was no significant difference between the effect of two therapeutic methods on pain and both exercise protocols had the same effect. In addition, Pilates and McKenzie training improved general health; however, according to the mean general health changes after the exercise therapy, it can be argued that the Pilates training has a greater effect in improving general health.

BODY.C.FINANCIAL SUPPORT AND SPONSORSHIP:
Nil.

BODY.C.CONFLICTS OF INTEREST:
There are no conflicts of interest.

Question: Compared to McKenzie training what was the result of Pilates training on Baseline characteristics?
Evidence: After therapeutic exercises, there was no significant difference between Pilates and McKenzie groups in pain relief (P = 0.327).
Answer: no significant difference