Funded by a CURA Communiversity Personnel Grant

Deinard, Amos

Salo, Kelley

University of Minnesota Digital Conservancy

M9208
PRELIMINARY DEVELOPMENT OF A STUDY PROTOCOL TO EVALUATE
THE EFFICACY OF ACUPUNCTURE THERAPY FOR TREATMENT
OF CHRONIC PAIN AND DEPRESSION
Kelley Sale, B.S
Amos Deinard, M.D., M.P.H,
CURA RESOURCE COLLECTION
Center for Urban and Regional Affairs
University of Minnesota
330 Humphrey Center
7/27/92
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IL'nvorsity of Minnesota
330 Humphrey Center
The Community-University Health Care Center/Variety Club Children's
Clinic (Clinic), a neighborhood-based, outreach clinic of The
University of Minnesota Hospital and Clinic (UMHC) has, for the
last seven years, run an acupuncture clinic in association with its
Mental Health unit. Acupuncture is used to treat Southeast Asian
(SEA) refugees, primarily the Hmong, Lao, Vietnamese, and
Cambodian, for the chronic pain that is associated with depression
from which so many of the adults suffer. Though medication may
alleviate the depression, the chronic pain still leaves the
patients dysfunctional (i.e., unable to go to work or school or to
socialize). Acupuncture is a culturally acceptable method of
treatment in the Asian culture; its availability draws patients
into the Mental Health clinic, which, in turn, makes it possible
to provide other services offered by the Mental Health unit as well
as medical or dental services if the patient is found to be in need
of more comprehensive treatment. For many patients, the Clinic may
be their first contact with Western medicine, and acupuncture,
along with a culturally sensitive mental health staff, seems to
make the transition somewhat easier.
Southeast Asian mental health problems are difficult to treat for
many reasons. A principal reason is reluctance of the patients to
present themselves for treatment. As in most cultures, there is
a stigma attached to mental illness. When mental illness, as a
concept in the English language, is translated into most SEA
languages, the implication is that the patient is "crazy." Thus,
Southeast Asians are particularly reluctant to associate with a
clinic or treatment that may cause this characterization to be
attached to them or their family. Even if the patient or family
members realize that there may indeed be a problem that needs to
be dealt with, a professional mental health care system was non-
existent in their country of origin and probably of little
availability in the refugee camps. Over the centuries, the culture
has called for such problems to be left to the family and immediate
community to manage as best they could. This family support system
is still in place in this country and continues to be very valuable
to the SEA refugee population. However, it has had limited success
in returning patients to a functional state.
When SEA patients do come to the Clinic for care, they tend to
express their depression more in terms of somatic, unlocalized pain
than in terms of their emotional state at the time. In facty many
do not realize that there may be a connection between their general
state of ill health and the problems they may be having adjusting
to a new culture or dealing with past emotional trauma. The
Clinic's Mental Health staff has come to recognize this group's
rather unique presentation of depression, and treats the patients
accordingly. Acupuncture has helped to bridge some of the cultural
gap by allowing patients many times to save face within their
community, while enabling the Mental Health staff to help those who
may otherwise have been alienated from the Western health care
system. Not infrequently, patients request only acupuncture
treatment•
Creating a blinded study that could examine the efficacy of
acupuncture therapy in cases of chronic pain and depression is
particularly difficult. First, while it is possible for physicians
to be blinded to the treatment in a drug therapy study, it is
impossible for a qualified acupuncturist to be unaware of whether.
true or placebo acupuncture is being performed, as it is he/she who
places the needles. Hence, in any research project, it will be
necessary for the acupuncturist to be conscious of ways in which
he/she may influence a patient's perception of his/her therapy, and
take precautions not to inadvertently reveal to the patient into
which group he/she has been placed. It also complicates the study
if the patient has previously received acupuncture and thus is able
to distinguish between true and placebo points. For every
condition, there are specific treatment points. To place the
needles in other than those points would alert the patient to a
sham procedure. Hence, if a control point could be established so
close to the treatment point that the patient cannot distinguish
the difference, research will be easier to design.
At every visit, the acupuncturist will ascertain each patient's
progress by report of the patient and of the patient's spouse,
child, or friend. These evaluations will be as objective as
possible and will be based on measurement of muscle strength,
tenderness at certain points as measured by a muscle/pain algometer
(which measures the amount of pressure that can be applied before
pain is felt), and functional level based on an evaluation of the
patient's daily activities. It should be possible to quantitate
these variables and so not introduce bias into the study. Separate
evaluations by the psychiatrist and mental health counselors and
staff will also be incorporated into the study to provide the most
comprehensive data base. An independent evaluator, blinded to
whether treatment or control points were used, will analyze the
data to determine efficacy.
One method of differentiating true versus placebo acupuncture
points is to use a galvonometer. Bullock and Culliton at Hennepin
County Medical Center have published two studies on the use of
acupuncture to treat chronic alcoholics. In these studies, they
used the galvonometer to determine placebo ear acupuncture points.
Treatment points gave a reading ^50 uA, while nonspecific points
always registered zero. From discussions with them, however, we
decided that the use of a galvonometer may not be as accurate when
the needles are placed on non-ear points. Acupuncture points over
the rest of the body have a wider response range detectable by the
galvonometer, perhaps because of increased conductivity of the
skin. This might prevent the use of the galvonometer in
determining needle placement during acupuncture therapy if non-
ear points are used. It may not be possible, for example, to find
an area of skin where conductance would be small enough, and
consistent enough from patient to patient, that an adequate placebo
acupuncture point could be localized. It will be possible to
evaluate the effectiveness of the galvonometer for this study after
a group of patients has been identified and the patients '
responsiveness measured at both therapeutic and placebo acupuncture
points.
Hung Nguyen, the acupuncturist at the Clinic, feels that specific
points can be isolated to treat a specific constellation of
symptoms. For a given patient, Mr. Nguyen would choose, at his
discretion, from a set of eight to ten acupuncture points. These
points may be different from the points chosen at a previous
session for that patient, and different from the ones chosen for
another patient, but they will always be from the same set of eight
to ten points. For example, if the diagnosis is lower back pain,
Mr. Hung would choose from ten acupuncture points (SR3, UB62, UB40,
GB30, DU26, K2, UB60, UB57, TW4, and GB41).
It is important that the patients who agree to participate in this
study fully understand the purpose of this study and what their own
involvement entails. The SEA refugee population already has a deep
suspicion that the Western medical system wants only to experiment
on them, and that, as a consequence, they are not given the same
quality of care that other groups receive. The effect of living
in a communist state for decades cannot be underestimated, and
their reluctance to sign their name to any agreement, especially
to participate in a medical study, is very real. Therefore, the
consent form that is used must be constructed so that proper
translation into their primary language is possible. Perhaps
willingness to participate can be expressed with a handshake rather
than a signature. It must be stressed that their participation in
the study will not compromise their overall health care at the
Clinic in any way and that they can withdraw from the study at any
time without compromising their relationship with the Clinic or
UMHC. The SEA staff will be available to explain the study and
insure that patients fully understand what their participation will
entail.
To evaluate better the effect acupuncture may have on a patient's
overall use of health care resources, we examined the possibility
of working with the Department of Human Services (DHS), Medical
Assistance (MA) program, to examine how the SEA patients used the
health care system before and after acupuncture treatments. Usage
would be reflected in the charges paid by M. A. A partial list of
procedures and diagnosis that may appear in a patient's medical
record relating to the treatment of chronic pain and depression
was compiled, and a preliminary search of the MA records at DHS of
ten former acupuncture patients was attempted. Unfortunately, the
codes we used produced such an overwhelming amount of information
that an adequate analysis was impossible to do without narrowing
or further defining the parameters of the search. DHS staff seem
willing to work with us in the future in establishing a more
efficient way of identifying and evaluating reimbursement data on
patients for this study. Unfortunately, they are in the middle of
converting their computer data base to a different system, and thus
will be unable easily to access such records until late 1992 •


Preliminary Development of a Study Protocol to Evaluate the Efficacy of Acupuncture Therapy for Treatment of Chronic Pain and Depression.

http://conservancy.umn.edu/bitstream/11299/205581/1/M9208.pdf

Preliminary Development of a Study Protocol to Evaluate the Efficacy of Acupuncture Therapy for Treatment of Chronic Pain and Depression.

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