Clinical Guideline Number 14, Acute Low Back Problems in Adults, recently released by the Agency for Health Care Policy and Research (AHCPR) represents a major validation of the effects of spinal manipulation (94 percent of which is performed by chiropractors in the US) in the management of acute low back problems. As with most things in life, it also represents a mixed bag of issues ranging from those that can be strongly supported to those that will be strongly opposed.
The International Chiropractors Association (ICA) was pleased to participate in the December 8, 1994 press conference at which the new guideline was released. The association has endorsed the guidelines "in principle." A final position of the ICA has been withheld until the association can complete a thorough evaluation of the document and its literature base can be completed.
There is no question that the ICA supports the development of responsible clinical guidelines where intention and methodology are above reproach. With this thought in mind we welcome the recent effort of the AHCPR relative to acute low back pain. The ICA continues to be cautious of any activity that serves to isolate the practice of chiropractic as a response to a small groups of conditions, such as acute low back pain or musculoskeletal conditions in general.
The association is firm in its conviction that the experience of tens of thousands of doctors of chiropractic over the last century indeed indicates the efficacy of chiropractic care for musculoskeletal conditions. But the experience base has also demonstrated the magnitude of the chiropractic concept and the impact that chiropractic care may have on conditions far removed from the traditional image of musculoskeletal problems.
The release by AHCPR actually involved three documents: the Clinical Guideline itself, a quick reference version for providers, and a patient version. It is worth nothing, particularly from the ICA perspective, that the guidelines referred to manipulation and spinal manipulation and the patient publication referred to spinal manipulation and spinal "adjusting." This implies that the public has a greater appreciation for our preferred terminology than the scientific community. The ICA is convinced that the protection of terminology such as spinal adjusting is far more than a matter of semantics. The use of our specific language reflects a greater appreciation for the care chiropractors provide. The use of the terms "manipulation" of "spinal manipulation" throughout the remainder of this article are reflective of the Clinical Guideline and are not the preferred terminology of the association.
A preliminary analysis completed by ICA has revealed a number of stunningly positive aspects to the report as well as a number of equally powerful concerns. Perhaps the most important aspect of the entire document, from a chiropractic perspective, relates to recognition of the benefits of manipulation to include "symptomatic relief and functional improvement" (page 35). Relative to low back pain this is the most significant finding of the entire effort as no other intervention was found to offer both symptomatic relief and functional improvement. Clearly the most obvious chiropractic concern raised by the guidelines relates to the use of x-ray in the management of acute low back pain. Consider the following statement: "Plain x-rays are not recommended for routine evaluation of patients with acute low back problems within the first month of symptoms unless a red flag is noted on clinical examination" (page 68). The impact of this position is of grave concern to many chiropractors, and will be discussed later in the article.
The guidelines hold a range of benefits to the practicing doctor of chiropractic that include:
a. recognition of spinal manipulation as the most effective nondrug, nonsurgical intervention for acute low back problems. With the recent release of an article in the New England Journal of Medicine dealing with kidney failure associated with acetaminophen use, an argument could easily be made that spinal manipulation in the most logical, reasonable and appropriate intervention of any kind -- drug, nondrug, surgical, nonsurgical. b. recognition of an initial course of care for the acute patient of up to one month before symptomatic improvement is noted. Consider the following: "If manipulation has not resulted in symptomatic improvement that allows increased function after one month of treatment, manipulation therapy should be stopped and the patient reevaluated." This statement needs a comprehensive and critical reading to understand all that it conveys. This does not say care should be stopped after one month in the absence of symptomatic relief with functional improvement. Logically it can be deduced that if the patient is progressing and there is symptomatic relief and functional improvement then there is no suggestion that care should be discontinued at 30 days. The outcomes measures associated with the care are also specified in this recommendation to the "symptomatic relief that allows functional improvement." This conveys the importance of functional indicators of improvement such as the Oswestry Index or an Activities-of-Daily-Living (ADL) index. At this point the chiropractor does not need to rely on measures that are subject to wide variations in interpretation. The Oswestry Index and ADLs offer valid, reliable, quantitative indicates by which to judge improvement.
c. recognition that the great majority of low back problem patients, without "red flags" as outlined in the guidelines, do not require elaborate studies at an early level. There has been a critical debate in the profession as to when spinal manipulation should begin in a patient with low back problems. One end of the spectrum says that no one should ever be touched until everything from complete blood chemistries and counts and prostatic examinations (in males!) have been completed. On the other end of the scale from the super diagnosticians are the non-diagnosticians. The guidelines establish a logical, reasonable position in between that is skewed to limited evaluation. The guidelines provide a straightforward algorithm that outlines the diagnostic pathways the chiropractor should consider.
The liabilities of the document are broad-based and are not specific to the chiropractor with the probable exception of spinal x-rays. The practitioner who makes use of extensive physical therapy procedures will find considerable fault with the guidelines. It broadsides almost all physical therapy-oriented interventions as "not recommended" in the management of acute low back problems.
There does not appear to be any consideration of the chiropractic specific application of x-ray as a biochemical assessment tool as well as a pathological and structural integrity determinant. Page 71 notes: "Plain lumbar x-rays have been demonstrated to be useful in helping detect or define spinal fractures, but alone do not rule in or out tumors or infections suggested by other findings." In this respect the reader gets the impression that all of "spinal manipulation" is lumped together in the mind of the conferees. The report appears to say that "manipulation" provides all the clarification and understanding necessary to make evaluations regarding such matters as the application of x-ray. It would be similar to considering all forms of medication as "drugs" and thereby being able to determine when and under what circumstance everything could be applied. This is the most disappointing aspect of the guidelines.
The x-ray related aspects of the document pose the most serious concerns to the ICA. Recently, rare adverse outcomes of chiropractic care have been featured in the media. The failure to x-ray has reared its head in several of these cases. A dutiful application of the guidelines would limit the use of x-ray to those cases where fracture, tumor or infection was possible. "Evidence suggests plain x-rays are rarely useful in evaluating or guiding the treatment of acute low back pain in the absence of red flags." (page 71)
The issues that the report takes with plain x-ray in low back problems is not related to cost but rather "to the degree of ionizing radiation exposure." The profession has an opportunity to identify more clearly the uses of x-ray from a management of care basis as well as to develop protocols and procedures that will minimize the exposure to ionizing radiation.
One of the great battles of all time in the chiropractic profession has related to the use of various therapies in chiropractic practice. This report does not address the use of such procedures in the full spectrum of cases seen by chiropractors, but it does have a great deal to say about using these procedures in the management of acute low back problems.
Panel findings and recommendations relative to the use of "physical agents and modalities" in the management of low back problems include identifying the following interventions as "not recommended" -- ice, heat (including diathermy), massage, ultrasound, cutaneous laser treatment and electrical stimulation. Further, the report also comes to similar conclusions of "not recommended" for TENS, lumbar corsets, traction and acupuncture.
The impact of these recommendations will be devastating to the physical therapy profession, at least in their involvement in the management of acute low back problems. For those chiropractors who utilize these procedures the impact will also be profound. An aggressive stance by third-party payers in these situations could be a major source of consternation for some practitioners. It is worth noting that these procedures, were "not recommended" on the basis of their cost: "... use of physical agents and modalities in the treatment of acute low back problems is of insufficiently proven benefit to justify their cost" (page 36). X-ray, you will recall, was of concern due to ionizing radiation and not cost. In this situation if a person wished to apply various physical agents at no cost to the patient there does not seem to be any inherent malpractice liability. But the use of x-ray in the routine acute low back patient could be construed to increase or create a potential for liability.
The Clinical Guideline may change greatly the malpractice environment but that change will most dramatically impact the surgeon. With the advent of the perspectives expressed in this document, we are rapidly approaching the point where a surgeon, when consulted by an acute low back pain patient, must recommend a course of spinal manipulation. When one considers the negative impact of such drugs as NSAIDS and acetaminophen and the absolute minimal complications of lumbar spinal manipulation, a responsible person would be hard pressed not to move in the direction of spinal manipulation. Considering the relatively dismal performance of spinal surgery, one could conclude that even if a surgeon followed "conservative" management with NSAIDS or acetaminophen, he or she could be held liable for not recommending an additional course of conservative care involving manipulation.
The approach to the evaluation of acute low back problems is clearly outlined in the clinical algorithms. Failure to follow these at a minimum will undoubtedly lead to increased exposure. But consistent application of the guidelines may also result in considerable insulation from exposure, even in the presence of an adverse outcome. Consider the impact of the following statement: "Patients with acute low back pain alone, who have neither suspicious findings for a significant nerve root compression nor any positive "red flags" do not need surgical consultation for possible herniated lumbar discs." Assume you had a 45-year-old patient who presented exactly as outlined above. The patient left your care and sought care of an orthopedist, and MRI was ordered and a herniated disc was found in this patient. In the past you might have had a problem for not referring, for being associated with the herniation (even though 40 percent of 40-year-olds have asymptomatic lumbar herniations), and you may be on the receiving end of a suit. This document clearly protects you.
The bottom line for any provider will be: How does this affect the way I deal with my patient? How does it affect my current procedures and how will this affect my ability to be compensated for the service I render? For most doctors of chiropractic some change will be required to be in total compliance with the guidelines. Of equal significance is the fact that entire health care delivery systems will be impacted by the guidelines. While you may need to change some procedures to be in compliance, HMOs, PPOs and managed care structures of all kind must seriously examine the services they are providing their clients, and the new huge gap that exists if they do not provide qualified people (doctors of chiropractic) to deliver spinal manipulation to their acute low back population.
Your patient intake procedures need to be examined. Are you covering the range of questions to elicit the presence of "red flags" in the history? Further, you should consider the routine use of patient feedback mechanisms. "Clinicians are urged by some authors to augment the medical history with pain drawings and visual analog rating scales to document the distribution of pain and the intensity of symptoms" (page 19). In addition the use of indices such as the Oswestry or Roland-Morris is very important. If you wish to shift the emphasis of your measures from pain to function then you should strongly consider the use of Activities of Daily Living scales. Reliance on the level of pain as the sole indicator of response to care shortchanges the patient, you and chiropractic. Pain may still be present but functionality may have been tremendously enhanced.
Your x-ray procedures must be examined. The "red flags" indicating a possible need to x-ray will embrace a great many patients, contrary to the conclusions of the report. Plain x-rays or the lumbar spine are recommended with acute low back problems and any of the following: "recent significant trauma (any age), recent mild trauma (patient over age 50), history of prolonged steroid use, osteoporosis, patient over 70" as well as "prior cancer or recent infection, fever over 100 degrees (F), IV drug abuse, low back pain worse on rest, unexplained weight loss."
ICA members around the country have related that between 60 and 95 percent of their low back patients would be persons who demonstrated a "red flag" indicative of the potential need to x-ray. Nonetheless it must me remembered that the guidelines do not support plain x-rays for the "routine evaluation of patients with low back problems."
Therapy use is a big question, not only from the historical debates within the profession but now from the cost-effectiveness perspective of AHCPR. There does not appear to be any recommendation against the use of such procedures, only that their clinical utility does not warrant the associated costs. If a practitioner genuinely felt these procedures were in the best interest of a patient, they could apply them, but to be in compliance with the guidelines they should do so at no cost.
In conclusion, it is apparent that this Clinical Guideline will provide great validation for the public's use of chiropractic care to manage acute low back problems. Further, it is quite conceivable that the greater effect of this report will be to remove the "cloud" that past disinformation campaigns have created for many within government, the insurance industry or other policy making positions. We may now have the opportunity to compete on a level playing field and the public may now have the opportunity to access valid and reliable information based on the facts. Further, we have been provided with a research agenda for the profession relative to areas in which documentation was found insufficient.
The challenge for the individual practitioner and for the profession at large will be to assure that this recognition of the value of chiropractic care is viewed as a significant beginning. We must make every attempt to position chiropractic care and chiropractic practice as providing the public with the full benefit of the spinal adjustment not only for musculoskeletal problems but for all other conditions that result from vertebral subluxation.
Gerard Clum, DC
San Lorenzo, California
