|
Articles
on Chiropractic Research
Research
Grants and Grant Information
|
|
|
Chiropractic
Research Retrospective
By
George McClelland, DC
Reprinted with permission from the Journal of the
American Chiropractic Association, March 2000.
THIRTY YEARS AGO, when I finished
chiropractic college, chiropractic research was an oxymoron. In fact,
research specific to spinal manipulative therapy, or more specifically
chiropractic manipulative therapy/adjustment as performed by doctors of
chiropractic, just didn’t exist. Since that time, this has changed
dramatically—especially over the last 20 years. In fact, it was only 20
years ago this year that the first peer-reviewed, and subsequently
indexed, scientific journal was developed in the chiropractic profession,
now known as the Journal of Manipulative and Physiological Therapeutics (JMPT).
Even 13 years ago, there was only this one scientific journal in the
chiropractic profession. Today, there are more than 10 peer-reviewed
scientific chiropractic journals in North America alone.
One of the primary reasons for this burst
of chiropractic-related research in the last 20 years is an organization
called the Foundation for Chiropractic Education and Research (FCER). This
organization was founded in 1944 as a subsidiary organization of the
American Chiropractic Association’s predecessor, the National
Chiropractic Association. It was not, however, until 1981 that FCER began
making major strides toward developing, funding, and administering
chiropractic research with a strong focus on clinical studies. In fact, an
October 1998 article written by Keating, et al., in JMPT noted that FCER
had funded the largest number of papers (24%) published in JMPT between
1989 and 1996. The paper also noted that this was a seven-fold increase in
the number of controlled clinical trials performed in the previous 10
years. Through the primary support of the American Chiropractic
Association, the National Chiropractic Mutual Insurance Company, and the
chiropractic profession at large, FCER (since 1980) has awarded 160
grants, which have resulted in 233 publications and 251 presentations.
Additionally, it has funded 90 post-doctoral fellowships, as well as 17
research residencies in chiropractic colleges. This has resulted in just
under $10 million awarded within the chiropractic profession. The FCER has
been, and continues to be, the largest, most active, and well-known
research development and funding agency in the chiropractic profession.
So, what is the quality of the research
being turned out in chiropractic today? A recent critical literature
review of 27 randomized clinical trials published between 1966 and 1995
addressing neck pain was published in the Scandinavian Journal of
Rehabilitative Medicine (Kjellman et al, 1999; Vol. 31, pp. 139-152). This
meta-analysis by Kjellman ranked an FCER-funded study by Patrick Boline,
et al., at Northwestern Chiropractic College the highest for
methodological quality of all the studies reviewed. The Boline study,
entitled, "Spinal Manipulation versus Amitriptyline for the Treatment
of Chronic Tension-Type Headaches: A Randomized Clinical Trial," was
published in JMPT in March/April 1995. That particular study shows very
favorable longer-lasting results for tension headache sufferers that
utilize manipulation versus amitriptyline. This is the second time the
Boline study was ranked highest in a meta-analysis for methodological
quality. The previous meta-analysis done by Hurwitz, et al., was published
in Spine in 1996.
Probably the biggest splash that
chiropractic or spinal manipulative therapy has made on the media front
came in December 1994 with the federal government’s release of the
Agency on Health Care Policy and Research’s (AHCPR) Clinical Practice
Guideline #14, entitled, "
Acute Lower Back Problems in Adults"
Regarding spinal manipulation, the literature reviewed in that particular
study included at least 29 controlled trials, nine of which focused on
acute low-back problems. From that study, it was determined that spinal
manipulation had the same level of efficacy as did non-steroidal
anti-inflammatory drugs (NSAIDs). They also threw in certain
over-the-counter analgesics, like Tylenol. Interestingly, there were only
four randomized controlled trials (RCTs) for the NSAIDs. There were no
other health care interventions (e.g., medications, physical therapy,
surgery, or acupuncture) that came close to these in their established
scientific evidence or acceptance by the panel of experts that reviewed
them. Ever since the release of Guideline #14, chiropractic has been more
accepted in the medical realm as being an effective treatment for acute
low-back pain.
One other issue that came out of Guideline
#14, as well as the British Guidelines for Low-Back Pain, which came out
at about the same time, was the statement that most back problems clear up
within 30 days. In fact, this point has been utilized by many third-party
payers to limit intervention (especially chiropractic) in the treatment of
low-back pain. A number of articles, however, have been published recently
that take exception to this issue. Actually, these were highlighted best
in an article in the Back Letter (1999, Vol. 14, No. 6, Lippincott,
Williams & Wilkins), which made some strong points to the contrary.
This article, entitled, "Acute Back Pain, Benign but Frequently
Persistent," evaluated six different articles published in the
scientific literature since 1986.
The key points of this article were:
Pain symptoms are likely to improve, but
not disappear
Functional limitations are likely to
lessen over time
Functional limitations may persist in a
minority of patients
Predictors of chronicity are largely
psychosocial
Viewing the course of back pain as acute
or chronic may be an oversimplification
Probably the most noteworthy article in
this group of six published studies was one entitled, "Outcome of
Low-Back Pain in General Practice: A Perspective Study" (British
Medical Journal, 1998; Vol. 316; pp. 1356-1359). This article by Peter
Croft, et al., took to task the claim that 90 percent of episodes of
low-back pain resolved within one month. In fact, in follow-up interviews
with the patients in a family practice setting, they found that of 490
adults who presented with acute low-back pain, only 21 percent had
completely recovered in a three-month period of time and, by the end of
one year, only 25 percent had complete recovery. I especially like Croft’s
characterization of low-back pain in which he stated, ‘It should be
viewed as a chronic problem with an untidy pattern of grumbling symptoms
and periods of relative freedom from pain and disability . . ."
A more recent study, entitled,
"Chronic Spinal Pain Syndromes: A Clinical Pilot Trial Comparing
Acupuncture, a Non-Steroidal Anti-Inflammatory Drug, and Spinal
Manipulation" (JMPT, July/August 1999, Vol. 22, No. 6), evaluated 77
patients that were randomized into the three groups and found spinal
manipulation superior to the other interventions. Dr. Lynton Giles and the
other authors from the Townsville Spinal Pain Unit in Townsville,
Australia, were pleased to find that one of their interventions provided
significant positive outcomes: 30 percent for low-back pain on the
Oswestry scale, 25 percent on the Neck Disability Index, and 50 percent on
the Visual Analog Scale for low back—with 46 percent for upper back pain
and 33 percent for neck pain. They were also quick to point out that
guidelines need to be established for chronic spinal pain syndromes.
Currently, similar studies are being pursued in the chiropractic
profession.
One of the difficult aspects of developing
appropriate clinical trials in the chiropractic profession is the
determination of an appropriate placebo or sham to be utilized in a RCT.
In fact, two recent studies funded and administered by FCER received
considerable criticism regarding how benign the sham procedures
(soft-tissue manipulation/massage) really may have been and what
consequence the use of these shams may have afforded the study. The first
of these studies, "A Comparison of Active and Simulated Chiropractic
Manipulation as Adjunctive Treatment for Childhood Asthma" (New
England Journal of Medicine, 1998, Vol. 339, No. 15, pp. 1013-1020), was
written by Jeff Balon, et al., and found that chiropractic manipulative
therapy gave no significant benefit over the other medical interventions
in the treatment of childhood asthma. A second article, entitled,
"Spinal Manipulative Therapy vs. a Low-Force Mimic Maneuver for Women
with Primary Dysmenorrhea: A Randomized, Observer-Blinded, Clinical
Trial" (Pain 1999), was performed by Maria Hondras, et al., and also
did not support the greater effectiveness of spinal manipulation in the
treatment of primary dysmenorrhea.
Because spinal manipulation requires
physical contact with a patient, it has become very difficult to determine
sham procedures that could be utilized in place of spinal manipulation to
perform appropriate RCTs. In fact, a recent study by Donald Dishman, a
researcher at New York Chiropractic College, demonstrated that the
cutaneous nerve receptors could not determine between a soft-tissue sham
procedure and a side-posture manipulation. This would seem to support that
sham manipulative procedures, which include soft-tissue manipulation,
would not be an appropriate contrast for spinal manipulative procedures.
It is anticipated that Dr. Dishman’s article will be published in a
scientific journal in the near future.
Another issue of great concern in the
chiropractic profession is that of cervicogenic headaches. This refers to
headaches that primarily have their origin in the neck. Although
chiropractic has been managing this type of headache for the greater part
of this century, it has only been in the last five years that there has
been more research acknowledging the presence of cervicogenic headache and
its management. Probably the most outspoken authority on this is a Dr.
Peter Rothbart, a neurologist in Toronto, Canada, who was the subject of
an article in the December 1995 Toronto Star. Dr. Rothbart noted that more
than 80 percent of the headaches seen in his neurological clinic have
their origins in the cervical spine.
A subsequent article in The Chiropractic
Report, edited by David Chapman-Smith, also of Toronto, cited five
different studies performed in the United States, Italy, Canada, and
England in 1994 and 1995 that addressed this same type of headache. Three
of these studies even addressed the effectiveness of spinal manipulation
and the treatment of this headache form.
I had the opportunity in 1995, on behalf of
ACA and FCER, to testify before the AHCPR’s panel on Chronic Pain
Headache. Unfortunately, due to apparent funding changes for the AHCPR,
that study and the consensus panel, which was being managed by Duke
University, was dismantled. There was a resultant paper published last
year that addressed migraine headache from the information gathered. The
rest of the information that pertained to the more prevalent tension
headache, as well as cervicogenic headache, was not published.
Fortunately, through continued pressure by FCER, we have now worked out an
arrangement with Duke University to develop a new study that would first
of all look at the previously existing information on all forms of
headache, including migraine, and add the current research since 1995. It
is known that there is a much greater volume of information that pertains
to favorable chiropractic management of multiple forms of headache. It is
anticipated this new study could be submitted for publication within the
next year.
Currently, there are at least two other
asthma studies going on that look at the efficacy of chiropractic
management and the use of spinal manipulation in the treatment and
management of this chronic debilitating condition. One study is being done
by Ray Hayek at Macquarie University in Australia. The preliminary results
of this study were reported last year in Vancouver at the International
Conference on Spinal Manipulation (ICSM) and appear to be more in line
with the more positive case studies that have been experienced in
chiropractic over the decades. Another asthma study is a pilot being done
by Gert Bronfort at Palmer University in Davenport, Iowa. The paper from
this study has already been submitted for publication.
Another study that was funded over five
years ago by monies provided by NCMIC through FCER administration is the
ABT Primary Care Study. The ABT Study has produced a number of papers for
publication already. Two of these address wellness or maintenance care, as
provided by chiropractors. These papers have been accepted for publication
and are currently going through review. One outcome described in these
papers was that elderly chiropractic patients under maintenance care had
over a 70 percent reduction of average per capita expenditure for health
care services, as compared to the national average.
Currently, there is a study going on at
Harvard entitled, "Managed Care Alternative Medicine Pilot."
This pilot study was assisted by funding from the chiropractic profession
(FCER and NCMIC). As a result of the pilot’s success, a full-scale study
has currently been funded by the National Center for Complementary and
Alternative Medicine. This study will evaluate patients with back pain
that will be randomized under managed care control to medical
interventions or their choice of several complementary and alternative
medicine procedures including chiropractic, acupuncture, and massage.
Certainly the Department of Defense’s
(DOD) Chiropractic Demonstration Project, which has been in existence
since 1995 and is currently being tested at 13 separate military sites,
has great importance to ACA and the patients we serve. Although the DOD
was authorized in 1993 (1993 Defense Authorization Bill) to commission
doctors of chiropractic (DCs) in the military, it was not until the
passage of the 1995 Defense Authorization Bill that funding was provided
for this pilot program. It is our understanding that utilization, positive
outcomes, and patient satisfaction have had high marks on this pilot study
to date.
In addition to the above studies, there are
several studies that are currently in publication or are at some level of
completion. These include:
An evaluation of which forms of
chiropractic manipulative therapy are better supported by the
literature in the treatment of specific low-back pain complaints.
A comparative study of the treatment of
sciatica utilizing chiropractic manipulative therapy, medication, and
epidural steroids.
Dr. Gary Hack and his group of
researchers are currently looking at the effectiveness of conservative
management of the anatomical myodural connections that he discovered
several years ago between the rectus capitus posterior minor and the
dura mater, and its relationship to tension headaches.
There are a number of basic science
studies that are going on using both the cat and rat models to
determine what effects spinal mechanical misalignments, or subluxation
if you will, have upon these animals.
I
think we can at least say that chiropractic research is certainly no
longer an oxymoron. It is apparent through the increase in collaborative
research that has gone on in the scientific community, as well as the new
federal funding sources that have opened up for chiropractic in the last
five years, that although chiropractic research may be the "new kid
on the block," it is definitely making itself known.
Return to the RESEARCH ARTICLES Section
|
MemberWeb