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The following is a reply from the McKenzie Institute to a study recently published in the New England Journal of Medicine (From the Chiro-List 12/21/98)

Reference for the Following: Spine Line - Newsletter of the McKenzie Institute USA - Vol 2, Number 4 - Fall 1998

The McKenzie Institute's Reply to the recently published study by Cherkin et. Al (see "A Comparison of Physical Therapy, Chiropractic Manipulation, and Provision of an Educational Booklet For The Treatment of Patients With Low Back Pain" - NEJM, October 8, 1998, Vol. 339: 1021-29)

Note: Additional and varied reply's to this study will be available in future McK. Inst. Newsletters "Spine Line" - 1-800-635-8380)

Before detailing the McKenize Institutes reply, note the following: Firstly, I found it interesting that the American Chiropractic Association (ACA) Called The McKenzie Approach a type of "Stretching Treatment." It would behoove the ACA to investigate what McKenzie is before commenting. With all due respect, it is rather unenlightened to relate that it is simply a 'stretching treatment, to say the least. (Visit: http://www.mckenziemdt.org/ on the Internet)

Now for The McKenzie Institute International's Reply to the aforementioned NEJM study:

The study randomly assigned acute low back pain patients to one of the two treatment groups, or a control group. The treatment groups received either manipulation from chiropractors or McKenzie exercises and a posture control program. The study demonstrated that patents receive spinal manipulation experienced the same benefits as those receive a modified version of the McKenzie protocol.

This demonstrates that a structured individualized exercise program is just as effective as manipulative therapy. This has relevance since, in the past two years, the guidelines for the treatment of acute back pain issued in both the USA and UK recommended that manipulation should be prescribed for patients in the acute stages. {Side Note: Steven Lewis, DC: McKenzie's combination of exercise, self-care and manual therapy provide the foundation for spine care best supported by the literature and prescribed by AHCPR and HealthPartners guidelines. Health Partners, St. Paul, MN: HealthPartners is a nonprofit Minnesota health management organization with approximately 600,000 patient subscribers. Full credentialling of chiropractors participating in the HeathPartners networks requires completion of a McKenzie Part A course, in addition to a Cyriax-based extremity course. Providers practicing within medical clinics are expected to compete Parts A through D (Lewis, Lecture and manual information, The McKenzie Institute, USA Educational Update and Second General Membership Meeting, Minneapolis, MN, July 15, 1995)}

To continue with The McKenzie Institute International's Reply To The NEJM Study:

Although the study purported to utilize the McKenzie treatment protocol, several requirements of the protocol changed both the intent and practice of the McKenzie program. The design required patients to be entered with "intention to treat." However, the McKenzie system is both diagnostic and therapeutic. It is designed to identify patients whose condition is suitable and responsive to a mechanical approach to treatment. It is also able to identify patients who are unsuitable for a mechanical treatment program and who, in normal circumstances, should be referred for more appropriate treatment or further investigations. Under the "intention to treat" requirement, patients identified as unsuitable by the McKenzie assessment process ere nevertheless included in the McKenzie treatment group, where they would unfortunately be counted as treatment failures.

Further, the McKenzie treatment protocol includes the use of spinal manipulation where indicated. Therapists in this study were not able to deliver this particular aspect of the McKenzie treatment protocol, even though patients in the study may have had clear indications for its delivery. The laws of the State of Washington do no permit physical therapists to provide spinal manipulative therapy, thus patients in the McKenzie group were further disadvantaged.

Cherkin, in a previous study, found that the pamphlet used as a control in this study had little or no effect. In this study, both chiropractic and the McKenzie program were found to have been only slightly better than that much less expensive pamphlet. Of course, it is disappointing to find that neither manipulation nor the McKenzie system was superior to an inexpensive booklet. What the study fails to identify are the patients who benefited from the three study treatments.

This is a real problem with all outcome studies on low back pain subjects. Until patients with this symptom are placed into meaningful sub-groups at the outset of a study that then enables a more detailed analysis by sub-group, outcome studies will yield little worthwhile information. The McKenzie treatment program is based on the diagnosis of three sub-groups of patients in this difficult spectrum. The study failed to identify which patients improved and which patients failed to improve in the sub-groups. Although these concerns had been previously expressed, the study design did not allow for these distinctions to be made. There has been a strong clinical impression that patients with high incidence of recurrencebenefit from the self-treatment approach and are seemingly able to abort or prevent the onset of future attacks. Indeed, at the three-month follow-up of this study, over 70% of the patients in the McKenzie group reported that, in the event of recurrence, they felt able to manage the problem themselves. At two years, utilization of further medical service did not demonstrate that patients had managed their own problems. Unfortunately again, the specific group of patients which high recurrence rate prior to the study was not identified. Had the incidence of long term benefit in these patients been measured specifically, a more meaningful result may have occurred. Future studies should identify in advance those patients with frequent recurrence.

A further cause for concern arises from the very low (55%) patients compliance reported by the therapists involved in the study, well below an acceptable level. Once would not expect good results from a method of treatment that was in fact never carried out by nearly half the patients assigned to that treatment. Nor further explanation was reported as to why this compliance was so low.

Although not reported in this study, the data received from the two Physical Therapy Departments showed that the results obtained by one were much better than the results obtained at the other center. This suggests that either the quality of treatment was higher at the center with the superior result or that the patients differed between centers as to their complexity. Further analysis of those two centers would be informative.

In conclusion, a much more meaningful study would include the identification of subgroups at the time of initial assessment to compare with treatment outcomes. This is strongly supported by the growing number of studies showing the improved outcomes in centralizes vs. non-centralizers. The expenditure of large resources to study various treatments of a non-specific symptom cannot be justified in light of what is presently in the literature regarding the outcome prediction capability s of the McKenzie assessment.

Additionally, the full assessment and treatment program needs to be permitted and followed by the treating therapists as well as the patients.

Here's some more relevant info.: (Additional Info. available at: http://www.mckenziemdt.org/ on the Internet) Studies regarding Centralizers vs. Non-Centralizers

J Orthop Sports Phys Ther 1998 Mar;27(3):205-212 Centralization of low back pain and perceived functional outcome.Sufka A, Hauger B, Trenary M, Bishop B, Hagen A, Lozon R, Martens BVeterans Administration Medical Center, St. Cloud, MN, USA. McKenzie's methods for evaluating and treating low back pain are used often but studied little. When using the McKenzie system, it is important to observe signs of symptom movement to a central location (centralization).

This study investigated the relationships between centralization of low back pain and/or radiculopathy and the subjects' rating of functional outcome. Thirty-six subjects with low back pain volunteered to participate and were evaluated and treated by six researchers. Subjects were tested initially and again 14 days after initiation of treatment using the Oswestry Low Back Pain Disability Questionnaire and the Performance Assessment and Capacity Testing Spinal Function Sort (SFS). Symptoms were monitored for the occurrence of "complete centralization." Of the 36 subjects, 25 showed complete centralization within 14 days. The SFS score changes were significantly higher for subjects who completely centralized (p = 0.015). The results supported the hypothesis that subjects who centralize will have improved functional outcome and, thus, quality of life. However, shorter time to occurrence of complete centralization does not necessarily correlate with improved outcome.

Case #2. Spine 1995 Dec 1;20(23):2513-2520 The centralization phenomenon. Its usefulness as a predictor or outcome in conservative treatment of chronic law back pain (a pilot study). Long AL Columbia Rehabilitation Centre, Calgary, Alberta, Canada. STUDY DESIGN. Two-hundred-forty-three patients with chronic low back pain were studied in a prospective comparative survey to determine whether the "centralization phenomenon" was associated with outcome after an interdisciplinary work-hardening program. OBJECTIVE. The hypothesis was that patients who demonstrated centralization during initial mechanical assessment would have better outcomes than noncentralizers. SUMMARY OF BACKGROUND DATA. Overall, subjects had decreased pain intensity ratings (mean 20%), increased lifting ability (6-8 kg), and a 59.2% return-to-work rate at a mean of 9.7 months follow-up. METHODS. Patients were classified as either centralizers or noncentralizers, based on results of their initial assessment. Changes in pain ratings, one-time maximal weights lifted, Oswestry scores, and return-to-work status were compared between groups. RESULTS. The centralizers reported significant decreases in their maximum pain ratings (centralizers, 16%; noncentralizers, 6%) and had a higher return-to-work rate (centralizers, 68%; noncentralizers, 52%) than the noncentralizers. CONCLUSION. Centralization can help identify sub-groups within the population with chronic low back pain and could be a useful goal setting and case management tool in the rehabilitation of low back pain. PMID: 8610246, UI: 96193245

Case #3 This study correlated Waddels, centralization and outcomes. Hope this all helps. MJ Phys Ther 1997 Apr;77(4):354-360 The relationship between nonorganic signs and centralization of symptoms in the prediction of return to work for patients with low back pain. Karas R, McIntosh G, Hall H, Wilson L, Melles T Clinical Services-Eastern Ontario, Canadian Back Institute, Ottawa, Canada. BACKGROUND AND PURPOSE: The purpose of this study was to assess the relationship between the nonorganic signs (Waddell scores) of patients with low back pain, their response to repetitive end-range lumbar spine test movements (centralization of symptoms), and the rate of return to work at a 6-month follow-up. SUBJECTS: Patients were assessed at five locations of the Canadian Back Institute. A consecutive sample of 126 patients with low back pain, with or without referred leg pain, was selected and reviewed. METHODS: Physical therapists assessed patients' responses to repetitive test movements (centralization), as described by McKenzie, and tested the patients for nonorganic signs (Waddell scores). Therapists completed a data sheet that classified patients as either those who centralize their symptoms or those who do not centralize their symptoms and recorded their Waddell scores. Although the patients were classified at assessment, they remained in treatment. All patients followed a structured Canadian Back Institute protocol of active exercise, regardless of centralization status or Waddell score. RESULTS: The inability to centralize symptoms indicated a decreased likelihood of returning to work, regardless of the Waddell score. A high Waddell score predicted a poor chance of returning to work, regardless of the patients' ability to centralize symptoms. CONCLUSION AND DISCUSSION: A high Waddell score appears to be the best predictor of outcome, as indicated by return to work. PMID: 9105339, UI: 97259219

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"Dynamic testing by repetitive motion should always precede the application of hands-on procedures and is a vital part of any mechanical assessment programme." "By applying patient-generated forces in the form of repeated movements, the ****stability of healing and reduction of derangement is tested and potentially unstable pathologies are exposed." 'The progressive increase of the applied stress from patient-generated to therapist-generated forces is a built-in safeguard of the McKenzie approach." "Once improvement ceases or slows or centralization remains incomplete, the next progression utilizing an increase of applied stress is indicated. In this way repeated movement testing serves as premanipulative testing prior to the use of therapist technique.(Wijmen,P., The Use of Repeated Movements in the McKenzie Method of Spinal Exam.,The McKenzie Ins., USA, Newsletter, Vol. 3, #2, Summer, 1995, p. 25).

Mckinney, L.A. studied the long term effect of early mobilization exercises in patients with acute neck sprains after road accidents. The author's conclusion advises early mobilization after neck injury which reduces the number of symptomatic patients after 2 years and is *****************superior to manipulative therapy*************** and that prolonged wearing of a collar is associated with persistent symptoms at more than one level. Only 36% of those examined had a normal disc at all levels.
(British Medical Journal 1989; 299; 1006-8) Findings of a study entitled "Discographic Outcomes Predicted by the Centralization of Pain and "Directional Preference": A Prospective, Blinded Study, was presented at the Eighth Annual International Intradiscal Therapy Society Meeting, held March 15-19, 1995 in La Jolla (San Diego), California. Dr. Charles Aprill was the presenter. The study was performed by Charles April, M.D., New Orleans, Robert Medcalf, PT, Atlanta, GA and Ronald Donelson, M.D., William Grant, Ph.D., Kristine Incorvaia, M.S., State University of New York at Syracuse, NY.

The study demonstrated a definite reliability with regard to identification of symptomatic discs, disc containment status, and axial fissure pattern by the Dynamic Spinal Assessment (DSA) as described by McKenzie and the Dynamic Intervertebral Disc Model (DIDM), strongly supporting a cause/effect relationship between the DIDM and symptom response patterns of centralization and directional preference as identified during DSA. The McKenzie spinal assessment appears to be a dynamic, noninvasive, functional evaluation of symptomatic disc pathology. (Study information provided to me personally by Robert Medcalf, PT, Dip MDT; study also presented at the McKenzie Institute, USA, Educational Update and Second General Membership Meeting, Minneapolis, MN, July 15 and 16, 1995).

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