MANUAL MEDICINE DIVERSITY:
RESEARCH PITFALLS AND THE EMERGING MEDICAL PARADIGM
Eric A. Mein, MD
Philip E. Greenman, DO
David L. McMillin, MA
Douglas G. Richards, PhD
Carl D. Nelson, DC
[NOTE: This paper was published in The Journal of the American Osteopathic
Association, August 2001, Volume 101, Number 8, pages 441-444.]
Abstract
Recent studies published in leading medical journals have concluded
that chiropractic treatment is not particularly helpful for relieving asthma
and migraine symptoms because even though study participants showed notable
improvement in symptoms, those subjects who received sham manual medicine
treatments also showed improvement. Yet the sham treatment received by
control groups in these studies is reminiscent in many ways of traditional
osteopathic manipulation. This seems to represent not only a failure to
recognize the value of many manual medicine techniques but also an ignorance
of the broad spectrum of manual medicine techniques used by various practitioners,
from osteopathic physicians to chiropractors to physical therapists. Such
blind spots compromise research methodology with regard to manual medicine
studies, which could, in turn, diminish the role of manual medicine in
clinical practice. Osteopathic manipulative treatment provides an excellent
model for recognizing and integrating the full range of manual medicine
techniques into research and clinical applications because of the wide
range of techniques employed. The potential exists for these techniques
to contribute much to medical research and clinical practice - provided
that osteopathic physicians and other manual medicine practitioners work
to alleviate ignorance about the efficacy of various forms of manipulation.
Manual medicine covers a broad spectrum of techniques, including soft
tissue treatment and high-velocity low-amplitude (HVLA) thrusting. In osteopathic
terminology, these and many other manual medicine techniques as a whole
are commonly referred to as osteopathic manipulative treatment (OMT). [1]
Although many osteopathic physicians take the variety of techniques for
granted because of the rich heritage of their profession, there remains
ignorance of manual medicine diversity in the healthcare community at large,
and this has led to serious shortcomings in current research methodology
with regard to manipulation. Consequently, the role of manual medicine
in the emerging medical paradigm is uncertain.
Healthcare services that use manual medicine include osteopathic medicine,
chiropractic, physical therapy, and massage therapy. Specific types of
practitioners often rely more often on certain techniques or sets of techniques
than do other practitioners (for example, long-lever techniques with osteopathic
physicians, HVLA adjustments with chiropractors), but there remains considerable
diversity within manual medicine-oriented professions and significant overlap
between them. However, the research literature often fails to reflect this
diversity. For example, one recent study of treatments for low back pain
refers simply to "chiropractic" in the abstract and throughout most of
the article, as if a general set of modalities were being applied (the
article only noted briefly that adjustments were side-posture, HVLA adjustments
were the only chiropractic modality used). [2]
Early osteopathic physicians used a variety of articular and nonarticular
approaches to achieve their goal of normalizing blood flow. They used general
mobilizations (the osteopathic "general treatment"), long- and short-lever
manipulations of the entire musculoskeletal system, strain-counterstrain,
and specific pressures ("stimulation" and "inhibition") to influence and
regulate sympathetic nervous system functions. Also, drainage techniques
were part of commonly accepted practice. [3]
Early chiropractors, with the goal of normalizing nerve function by
reducing the vertebral subluxation, were somewhat more limited in their
approach, relying primarily on HVLA thrusts. As time has passed, chiropractors
have added considerably to their body of therapeutic applications, broadening
their range of manual articular techniques; adding manual reflex and muscle
relaxation techniques; and incorporating nonmanual therapeutic modalities,
such as electrical and thermal modes of therapy, bracing, casts, support,
traction, and nutritional counseling - all of which have been beneficial.
However, in their research approach to demonstrate the validity of manual
medicine, chiropractors have focused almost entirely on the HVLA spinal
adjustment, ignoring the diversity of other manual techniques with claims
of effectiveness. [4]
Problematic Research Methodology
Two well-publicized studies reported in leading medical journals illustrate
the potential methodologic problems associated with manual medicine diversity.
One such example is a study that compared "active" and "simulated" chiropractic
manipulation as adjunctive treatment for childhood asthma, conducted by
Balon and others. [5]
The active treatment consisted of "manual contact with spinal or pelvic
joints followed by high-velocity low-amplitude directional push often associated
with joint opening, creating a cavitation, or 'pop."' This treatment is
a standard HVLA technique used by a wide variety of practitioners, such
as osteopathic physicians, chiropractors, and physical therapists.
The simulated treatment involved the following parameters: (1) providing
"soft-tissue massage and gentle palpation" to the spine, paraspinal muscles,
and shoulders; (2) "turning the subject's head from one side to the other";
(3) providing "a nondirectional push, or impulse" to the gluteal area with
the subject lying on one side and then the other; (4) placing the subject
in a prone position so that "a similar impulse was applied bilaterally
to the scapulae"; (5) putting the subject in a supine position "with the
head rotated slightly to each side, and an impulse applied to the external
occipital protuberance"; and (6) applying low-amplitude, low-velocity impulses
"in all these nontherapeutic contacts, with adequate joint slack so that
no joint opening or cavitation occurred."
Jongeward [6] and Rossner [7] have questioned the appropriateness of
such simulated treatment, noting that standard chiropractic practice can
include soft tissue work. Another problem is that the simulated treatment
bears a marked similarity to a traditional general osteopathic treatment.
[8,9,10 (pp85-86)]
Balon and colleagues [5] summarized the simulated treatment by stating,
"Hence, the comparison of treatments was between active spinal manipulation
as routinely performed by chiropractors and hands-on procedures without
adjustments or manipulation." Based on the conclusions of the researchers,
it would seem they were unaware of the early osteopathic works addressing
asthma [8-10] and the more recent literature on OMT for respiratory conditions,
particularly by Kuchera and Kuchera. [11] The methodologic limitations
of the study by Balon and others with regard to manual medicine diversity
have been noted. [12] Balon and coworkers responded that they were unconvinced
by the evidence supporting the efficacy of their "simulated treatment.
" [13]
The results as reported by the researchers were "Symptoms of asthma
and use of B-agonists decreased and the quality of life increased in both
groups, with no significant differences between the groups." The conclusion
was that "the addition of chiropractic spinal manipulation to usual medical
care provided no benefit." [5]
Thus, the conclusion suggests an apparent failure of chiropractic to
address systemic dysfunction, such as asthma. Although technically this
conclusion is limited to HVLA spinal adjustments, the fallout will, for
all practical purpose, probably affect attitudes toward all types of manual
medicine and manual medicine practitioners. The problem is that while the
study is widely perceived as indicating a failure of manual medicine for
the treatment of systemic dysfunction, it may instead be indicative that
the subjects in both groups benefited - but from two distinct forms of
manual medicine. Ignorance (whether by lack of knowledge or by the choice
to ignore the available information) has severely distorted the findings
of this widely publicized study.
This study is not the only example of such confusion. A similar study
[14] demonstrates a comparable ignorance of manual medicine diversity,
duplicating the methodologic flaws, favorable outcomes, and unfounded conclusions
of the study by Balon and others. The researchers in this study compared
two forms of manual therapy for the treatment of tension headache. The
experimental treatment consisted of standard HVLA chiropractic treatment
and deep friction massage, plus trigger point therapy if indicated. The
subjects receiving this intervention were designated as the "manipulation"
group. The control group received deep friction massage plus low-power
laser light (considered not to be efficacious for tension headache). Thus,
essentially, one form of manual medicine is again compared to another.
The researchers observed that "by week 7, each group experienced significant
reductions in mean daily headache hours ... and mean number of analgesics
per day." [14] Because both groups benefited equally, the authors concluded
that "As an isolated intervention, spinal manipulation does not seem to
have a positive effect on episodic tension-type headaches." [14]
Both studies were reported in the mass media with the simplistic conclusion
that chiropractic does not work for such conditions as childhood asthma
and tension headache. The design and outcome of the studies do not allow
us to draw such conclusions, however. Perhaps a more accurate conclusion
should have been that we do not know if HVLA adjustments are specifically
helpful or not. Although the favorable outcomes could have resulted from
chance or placebo effects, a reasonable person might also justifiably conclude
that various forms of manual medicine can be helpful for these conditions.
Kuchera [15] recently discussed in detail the mechanisms by which OMT could
be used in treatment of headaches of various types. Ignorance of the diversity
and validity of the full spectrum of manual therapy applications confounds
the issue. More research is desperately needed - research which seriously
considers the full spectrum of manual medicine options from a variety of
healthcare professions.
Developing an appropriate research methodology is a challenge. Consideration
must be given not only to the diversity of potentially effective manual
techniques, but to the difficulty of identifying a simulated treatment
with no physical effects. Even light stroking of the skin may have significant
effects on physiology. [16] In contrast to randomized clinical trials of
drugs, double-blind methodology is not possible with manual medicine research;
the therapist is always aware of the technique being applied. Even blinding
patients is problematic, particularly if they have previous exposure to
manual techniques. Rather than a treatment/placebo comparison, perhaps
the only possible comparison will be between active treatment methods.
This then raises the problem of individualization of treatment; even the
study by Balon and others [5] acknowledges that the therapists tailored
their treatments to the needs of the individual patients. A wider discussion
of the methodologic issues inherent in the study of manual therapy is necessary
to counter the application of overly simplistic and inappropriate methodologies
in studies of manual medicine and in the media coverage of such studies.
Manual Medicine and the Emerging Medical Paradigm
So what does this have to do with osteopathic medicine? It would
seem that chiropractors and many members of the medical establishment involved
in reporting these studies are simply ignorant of the osteopathic medical
perspective. While this type of misunderstanding is neither new nor surprising,
it has tremendous implications for the future.
We are in the midst of a medical revolution, and in this revolution,
many questions are being asked about manual medicine and other techniques
that are sometimes referred to as "alternative" medicine. What is the role
of manual medicine in the emerging medical paradigm? Will manual medicine
be limited to relieving musculoskeletal pain? Will osteopathic manipulative
treatment remain a self-contained system of healing? Is there a legitimate
role for the full spectrum of manipulative techniques in the treatment
of systemic dysfunction?
Osteopathic medicine has a great deal to offer. Because of its rich
heritage of philosophy, research, and clinical techniques, the profession
can influence the direction of healthcare in a positive manner. Osteopathic
medicine has integrated the diversity of manual medicine techniques into
its own system in the form of OMT. Thus, osteopathic medicine is the single
best representative of manual medicine diversity currently available to
researchers and clinicians.
Another primary factor driving the current changes in healthcare is
economics. Not only must treatment options be safe and efficacious, they
must be cost-effective. The diversity of manual medicine techniques provides
a variety of approaches that could have significant cost-saving potential.
This is particularly true for simple regulatory techniques, as contrasted
with corrective techniques. For example, inhibitive pressure and thoracic
lymphatic pump applications can be easily adapted for application by lay
persons and therapists.
In a study on labor pain during contractions of gravid uterus at term,
lumbar inhibitory pressure was shown to be effective in reducing pain in
a group of 175 women. This simple technique was applied by husbands and
other family members, as well as by nurses and physicians. "Since back
pressure in a high percentage of cases was administered by the husband,
this suggests that training of husbands in the proper technique would minimize
staff time required in labor and delivery, as well as the need for medication."
[17]
Also, thoracic lymphatic pumping (TLP) has been shown to be at least
as effective as incentive spirometry in preventing atelectasis in patients
who have undergone cholecystectomy. In addition to its treatment efficacy,
the authors noted that TLP costs were lower than those for incentive spirometry
and that "the TLP treatment costs could be further reduced by training
a respiratory therapist to administer the treatment." [18]
There is historical precedent for involving lay persons and therapists
in the less technical manual therapy applications. The early osteopathic
physicians recognized a hierarchy of expertise with regard to technique.
One early osteopathic text-book was specifically written with the lower
end of this hierarchy in mind. In the preface to the second edition of
his book, Eduard Goetz acknowledged the accessibility of simple manual
medicine applications when he wrote, "The mere reading of the book cannot
possibly result in one's becoming a full fledged osteopath. The intention
is simply to impart sufficient knowledge of the mode of procedure to enable
the careful reader to apply the treatment in his home in case of emergency
and until such a time as a regular practicing osteopath can be called in
should that be found necessary." [10] (For those interested in the
work of Goetz and other early osteopathic physicians, some of their texts
are now available on the Early American Manual Therapy Web site at www.meridianinstitute.com.)
When considering the relatively low level of expertise required to perform
deep friction massage and soft-tissue techniques, such as those used as
control treatments in the previously discussed asthma and tension headache
studies, one wonders if there might be a role for family members or massage
therapists in treating conditions like asthma and headache. Theoretically,
the physician could become an educator, trainer, and supervisor of the
treatment regimen for certain conditions. With the increased emphasis on
home health and cost-effectiveness, this could be a workable model in the
new medical paradigm - so long as issues of training and safety are addressed.
Osteopathic medicine is now presented with the opportunity to contribute
to the broader emerging medical paradigm with regard to research into manual
medicine and clinical applications of manual techniques. Osteopathic physicians
are in an excellent position to shape the new paradigm, but they also face
the danger of sitting quietly on the sidelines while others determine the
role of manual medicine in the evolving health-care system.
References
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