Massage
is among the fastest growing complementary used in the United
States. This article systematically reviews the available evidence
on potential benefits and adverse effects of massage for people
with diabetes. Massage at injection sites may increase insulin
absorption. In addition, uncontrolled studies suggest that massage
may have a positive effect on blood glucose levels and symptoms
of diabetic neuropathy. However, randomized, placebo-controlled
studies are needed to confirm any short- and long-term benefits
of massage as a complementary treatment for diabetes and to further
define an optimal massage treatment.
Massage
has been recommended for diabetes for nearly 100 years. (1) However,
the usefulness of massage for people with diabetes remains unclear
as evidenced by a recent exchange on an Internet diabetes message
board. One writer posts the message, "Does anyone know if massage
can help diabetes?" The only reply is another inquiry: "Hi! If
you find out any information on massage therapy, please let me
know. I just want to help my 16-year-old daughter, who has been
diagnosed with diabetes. How do you think massage can help? Even
type 2 diabetics, do you think?" (2)
If these
writers were to surf the World Wide Web in search of answers to
their questions, they would likely be left confused and frustrated.
Internet information on this topic is fraught with unsubstantiated
claims. One site actually suggests that diabetes can be prevented
through self-massage. (3) Another reports on an individual who
allegedly had the bottoms of his feet massaged, eliminated large
amounts of sugar in his urine during the second week of treatment,
and then recovered from his disease. (4) How, then, do consumers
decide, or clinicians advise, about the usefulness of massage
to people with diabetes?
This article
aims to clarify what is and is not known about the usefulness
of massage for people with diabetes by summarizing a systematic
review of the scientific literature using Cochrane review methodology,
(5) a method specifically designed to maximize comprehensiveness
and minimize bias. Through this method, all relevant studies that
meet prespecified inclusion criteria are included in the review
regardless of their results.
Using this method, we will
address four frequently asked questions:
1. Can massage improve
insulin absorption, for example, by increasing serum insulin in
type 1 diabetes or increasing tissue insulin sensitivity in type
2 diabetes?
2. Can massage help normalize
blood glucose levels?
3. Can massage provide
relief of symptoms associated with diabetic neuropathy?
4. What
are the known adverse effects, contraindications, or precautions
related to massage for people with diabetes?
MASSAGE
OVERVIEW
Trends in Use and Attitudes
Toward Massage in the United States
Utilization
of massage is rising, making the examination of this issue quite
timely. From 1990 to 1997, the proportion of U.S. consumers using
massage jumped from 7 to 11% of the population, the most statistically
significant increase of any complementary medicine (CM) modality.
(6)
Despite
stereotypical images of people receiving massage as a way of pampering
themselves, nearly three-fourths of those who seek massage do
so for a specific health complaint for which they have already
consulted a physician. (7) Among rehabilitation outpatients, massage
ranks as one of the most common CM therapies sought. (8) Among
general practice patients, 32% report using massage, and this
proportion exceeds that of individuals reporting the use of herbs,
megavitamins, or meditation. (9)
Not only
is massage use increasing, but survey evidence indicates that
utilization will continue to rise as health plans provide reimbursement.
A recent health insurance survey found that respondents were not
only willing to pay more for their insurance if CM therapies were
covered but also ranked massage as the number one CM therapy they
would be most likely to use if it were covered by their health
plan. (10) Third-party payers, however, cite lack of efficacy
data as the primary reason for their reluctance to reimburse CM.
(11)
Massage
is among the CM therapies with the highest physician referral
rate, (12) and family practice physicians rate bodywork as the
CM therapy most likely to be beneficial and least likely to be
harmful. (13) Given the growing popularity of massage, it is not
surprising that magazines for people with diabetes have begun
to offer information about the therapeutic effects of massage.
(14)
Types of
Massage/Bodywork
Swedish
massage is the most widely practiced type of massage in the United
States. Developed in 1914 by Per Henrik Ling, this method is considered
one of the first scientific approaches to massage, aiming specifically
to affect the circulatory, lymphatic, and nervous systems. Long,
gliding strokes (referred to as friction) are used to enhance
blood and lymph flow; kneading (called petrissage) is used to
relax muscle tension; and tapping, cupping, and hacking movements
(called tapotement) are used to stimulate nerves. (15)
There are
other popular forms of bodywork in the United Stares. Trager uses
a gentle, rhythmic, rocking motion to help the body relax. (16)
Rolfing uses intense deep-tissue manipulation to restructure fascia.
(17) Craniosacral therapy aims at gently influencing the rhythm
and flow of the cerebrospinal fluid. (18) Neuromuscular therapy
manipulates the deep soft tissues to improve circulation, release
nerve entrapment, and deactivate trigger points. (19) Manual lymphatic
drainage lightly redirects subcutaneous lymphatic stasis or blockages
into functional lymphatic channels. (20)
Swedish
Massage Procedure
Swedish
massage is the manipulation of the soft tissues of the whole body
to bring about generalized improvements in health. Generally,
sessions range from 30 to 90 min. The procedure usually begins
with a medical history. Then, the massage therapist leaves the
room while the person receiving the massage disrobes and lies
under a sheet or flannel blanket on a massage table.
The massage
usually begins with the patient lying supine. The therapist administers
massage first to the arms, neck, and head and then progresses
to the torso, feet, and legs. The patient then lies prone, and
the legs, hips, and back are massaged. Massage lotion or oil may
be applied to minimize friction on the skin.
Trained
massage therapists work in spas, health clubs, private practices,
chiropractic offices, physical therapy practices, and hospitals.
Physiological
Effects of Massage
Several
studies have documented the relaxing effects of massage. Massage
has been demonstrated to reduce muscle tension in both subjective
self-reports (21) and objective electromyo-graphic testing. (22)
Relaxation
from massage has been demonstrated to be greater than that brought
about from rest alone. (23) Massage can reduce heart rate and
blood pressure, two features of the relaxation response. (24)
Additionally,
massage has been shown to decrease anxiety in a variety of patient
populations, including people with diabetes. (25-27) These stress
reducing benefits of massage have raised the possibility that
massage may be of benefit to people with diabetes by inducing
the relaxation response, thereby controlling the counter-regulatory
stress hormones and permitting the body to use insulin more effectively.
LITERATURE
SEARCH
Methods
A Medline search was conducted
for the years 1966 to 2001. Search terms included "massage," "touch,"
"chiropractic," "Trager," "Rolfing," craniosacral therapy," "neuromuscular
therapy," "acupressure," "Shiatsu," and "manual lymphatic drainage."
These search results were combined with a search of the terms
"diabetes," "blood glucose," "diabetic neuropathy," "hyperglycemia,"
and "insulin."
Searches
were also made of EMBASE (Excerpta Medica Database), PsychInfo,
MANTIS (Manual Therapies Information Systems), CAMPAIN (Complementary
and Alternative Medicine and Pain), CCTR (Cochrane Controlled
Trials Registry), Cochrane Collaboration Complementary Medicine
Field Trials Registry, the Bodywork Knowledge Base, (28) and the
Touch Research Institute Database. (29)
Trials reported in any
language were included if the study:
1. involved the administration
of massage either manually or mechanically to patients with diabetes,
and
2. measured
at least one relevant primary diabetes outcome (i.e., insulin
absorption, blood glucose, [HbA.sub.1c], or symptoms related to
diabetic neuropathy) or a potentially relevant secondary diabetes
outcome (i.e., induction of relaxation response, anxiety level,
quality of life, sense of well-being, depression, cortisol level,
blood pressure, or heart rate).
Results
Results of the literature
search identified one study (30) pertaining to the first of our
four frequently asked questions, three publications of two studies
(25-27) and one unpublished study pertaining to our second question,
one study (31) pertaining to our third question, and one report
(32) pertaining to our fourth question.
Studies
were found pertaining to Swedish massage and acupressure. No studies
were identified pertaining to the other brand names of bodywork
or chiropractic therapy. Therefore, these were omitted from further
analysis.
Question #1: Can Massage
Improve Insulin Absorption?
Our searches identified
one study (30) on insulin absorption in type 1 diabetes. No studies
were found examining whether massage can increase insulin sensitivity
in the peripheral tissues resulting in increased glucose clearance
in type 2 diabetes.
Dillon (30)
observed that eight lean, well-controlled patients with type 1
diabetes, using their usual dosages of regular and intermediate-acting
insulins, who massaged their insulin injection sites with an electric
vibrator for 3 mm at 15 mm post-injection, experienced higher
insulin levels and lower serum glucose levels by 15 mm after the
start of massage and 29 mm post-injection. At this interval, changes
were not statistically significant. Serum glucose levels, however,
fell 8.3% lower (P < 0.05) 30 mm after massage and 44 mm post-injection
compared to the control day when participants did not massage
their injection sites, and this was significant. At 45 mm post-massage,
the difference in glucose levels was even more striking (76 mg/dl
[+ or -] 6%) when compared to the control day (89 mg/dl [+ or
-] 4%).
The same
report (30) revealed 2-year follow-up data on these eight patients,
as well as on 18 others who had been massaging their injection
sites for 3 mm at each meal in order to achieve a beneficial postprandial
rise in insulin levels. After 3-6 months of massage, the mean
[HbA.sub.1] for the 26 patients fell from 10.56 [+ or -]1.73 to
8.55[+ or -]1.69%. (Normal [HbA.sub.1] was <8.2% according
to the laboratory assay used.) After 12-18 months of injection-site
massage, 8 patients had normal [HbA.sub.1] levels, and the remaining
18 patients had mean [HbA.sub.1] levels of 8.41 [+ or -] 1.58%,
a significant improvement from baseline (P < 0.001). Dillon
proposed that injection-site massage can improve conventional
insulin therapy by increasing the bioavailability of insulin in
the postprandial state.
Question #2: Can Massage
Help Normalize Blood Glucose Levels?
Three published results
(25-27) of two trials and one unpublished preliminary study have
examined the effects of massage on normalizing blood glucose.
Fields and colleagues,
describing a single-group, pre/post-test design in two publications
of the same study population, (25,26) reported that after 1 month
of parents administering nightly full-body massage to their children
with diabetes (n = 14), the children's glucose levels decreased
from an average of 158 to 118 mg/dl. Exactly when and how often
blood glucose levels were measured was not stated.
The authors
also reported that both parents' and children's anxiety and depression
levels decreased immediately after massage. However, the methodology
for measuring these levels was not reported.
Vest (27)
trained clinical staff to administer 15-mm sessions of breathing
instruction, light touch, and acupressure to diabetic patients
for 6 consecutive weeks using a one-group, pre/post-test design
(n = 12). Outcomes were blood glucose, persistence of physical
symptoms, and perception of well-being. Patients experienced a
reduction in blood glucose, anxiety, headaches, depression, work
stress, and anger. Self-reports also indicated the patients were
sleeping better and had improved relations with their families.
No P values were cited. When and how often blood glucose was measured,
the length of follow-up time, definitions of clinically significant
blood glucose changes, and proportions achieving the various changes
were not reported.
Preliminary
data were available from one small randomized trial comparing
people with type 2 diabetes receiving 45-mm, full-body massage
three times a week for 12 weeks (n = 6) to similar patients on
a waiting list for massage (n = 2). (M.C., unpublished observations).
Researchers found that of the six patients receiving massage,
[HbA.sub.1c] decreased in three patients from a baseline of 7.9,
8.3, and 9.8% to 7.3, 8.1, and 8.6%, respectively. In the other
three patients receiving massage, [HbA.sub.1c] increased from
a baseline of 7.4, 8.2, and 8.0% to 7.9, 10.0, and 8.5%, respectively.
These patients, whose glycemic control deteriorated while receiving
massage, were obese, injecting insulin, or both. None of the group
whose glycemic control improved with massage had either of these
characteristics. In the waiting list control group, [HbA.sub.1c]
level also declined from 7.3 and 8.6% to 6.9 and 8.4%, respectively.
Question
#3: Can Massage Provide Relief for Symptoms Associated With Diabetic
Neuropathy?
Our searches
identified one trial (31) assessing the effects of massage on
the symptoms of dia betic neuropathy. This single-group, pre/post-test
design assessed 25 patients with symmetrical diabetic neuropathy
of the lower extremities and complaints of burning, tingling,
pain, itching, restless legs, paresthesias, and often loss of
reflexes. The duration of disease was 6-17 years, and the duration
of neuropathic symptoms averaged 14 months.
All patients were treated
with syncardial massage, a mechanical leg massage technique in
which a cuff inflates at the moment an electrocardiogram pulse
wave passes beneath it. The cuff releases when the R wave of the
electrocardiogram signals. It is believed that the pressure provided
by the cuff aids the arterial elasticity in providing a fuller
contraction so that the flow of blood through the limb is increased.
In this
study, the cuff was initially placed around patients' thigh and
then around their leg for the last half of the treatment. Syncardial
massage was administered every 2 days with the total number of
treatments ranging from 20 to 30 in those who appeared to benefit.
Therapy was discontinued after the tenth treatment for those who
experienced no benefit.
Subjective outcomes were
defined as no effect, improved (decrease of patients' symptoms
to the extent that they considered the treatment worthwhile and
wanted to continue it after the first 10 treatments), or good
(complete disappearance of symptoms or symptoms becoming so slight
that patients considered themselves to need no further treatment).
At the 1-month follow-up, results showed good response in 14 cases
(56%), improvement in 8 cases (32%), and no effect in 3 cases
(12%).
Question
#4: What Are the Known Adverse Effects, Contraindications, or
Precautions Related to Massage for People With Diabetes?
A potential adverse effect
of massage for diabetes appears to be the risk of inducing hypoglycemia
in insulin-using patients. This risk is extrapolated from massage
studies using healthy volunteers. (33,34) None of the studies
of massage and diabetes reports adverse effects. However, it is
not clear from the reports whether adverse effects did not occur
or whether they did occur but were just not measured or not reported.
In the study
of massage for diabetic neuropathy, (32) Kurashova specifically
cites contraindications and precautions for people with diabetes.
In the beginning, it is recommended only to use continuous effleurage
(a light long stroke around the contours of the body, during which
the massage therapist does not press down into the tissues but
rather glides always in the direction of the heart). Massage should
begin with 5-7 min on the back, then proceed to the thigh, and
then to the calf. Approximately 20-30 min can be spent effleuraging
the posterior side of the body and 10-15 mm effleuraging the front
of the legs and the arms.
For patients suffering
from peripheral nerve damage, gentle friction of the lower extremities
can be added only after a sufficient amount of effleurage has
been completed. This may require 7-10 treatments of effleurage
before introducing friction.
Because
vascular dysfunction may render the tissues of a person with diabetes
fragile, friction should be done lightly to avoid vascular damage
or bruising. In swollen areas, friction should be avoided because
the direct pressure into the tissues that is characteristic of
friction may further close the dysfunctioning vessels. Pressure
should be sufficiently light so that the massage creates no pain.
DISCUSSION
We have examined the literature
pertaining to massage as it relates to diabetes, particularly
to insulin absorption/sensitivity, blood glucose levels, diaberic
neuropathy, and contraindications. However, important questions
remain unanswered.
Although
studies indicate that massage may influence insulin uptake at
the injection site and decrease blood glucose levels, it should
not be assumed that this is always a desirable effect. Rather,
the circumstances in which this would be a desirable, even salubrious,
effect versus an undesirable effect need further elucidation.
For example, if massage induces a relaxation response, thereby
controlling counter-regulatory stress hormones and allowing the
body to use insulin more effectively, this would be a desirable
effect. However, if massage concomitantly induces a precipitous
drop in blood glucose into the hypoglycemic rather than the normoglycemic
range in patients using hypoglycemic medications, this would be
an undesirable effect. Likewise, if massage over time assists
in normalizing glycemic control, as suggested by Fields and colleagues,
(26) that is a desirable effect. However, if drops in blood glucose
from massage make it more difficult to normalize glycemic control
and titrate medications, that w ould be an undesirable effect.
Given the
possibility that injection-site massage can increase serum insulin
as well as decrease blood glucose, more understanding is needed
about the appropriate timing of premassage insulin injection as
well as about the differences in the potential risks and benefits
to people with type 1 versus type 2 diabetes. From this knowledge,
ways to maximize benefit and minimize risk can be ascertained.
Although the existing studies
suggest that massage can help normalize blood glucose, important
questions need to be addressed before this can be accepted as
true. For example, most trials do not report the proportion of
patients who actually responded in a clinically significant way.
Although a clinically meaningful drop in blood glucose was defined
as 15% in one study, (25'26) there is no mention of the proportion
of subjects who achieved this clinically meaningful change. Instead,
it is noted only that the post-treatment blood glucose group average
more than achieved a 15% reduction over the baseline average.
This is problematic because group averages are notoriously vulnerable
to large changes in just a few patients and can lead to falsely
optimistic conclusions about an intervention based on one or two
very good responders.
Reporting
standard errors with group means makes means more interpretable.
However, these statistics were not provided. Medians and quartiles,
on the other hand, are largely invulnerable to skewed data, and,
similar to reporting proportions improved/not improved, can provide
a more complete profile of how the study populations responded
overall.
A further
limitation exists in the selection of study designs. Most of the
identified studies used single-group, pre/post-test designs, which
do not control sufficiently for confounders. For example, in one
study, (26) dietary and insulin compliance increased during the
same 1-month experimental massage treatment period, but this was
not offered as a possible explanation for decreases in blood glucose.
Remissions related to the natural history of a disease or symptom
as well as placebo effects can also be major confounders. For
example, in one drug intervention study of diabetic neuropathy,
(35) 15% of the placebo group reported having no pain by the end
of the study, and 33% in the placebo group had at least a moderate
improvement on the Patient Global Impression of Change scale.
Clearly, for a symptom such as pain from diabetic neuropathy,
which can have both placebo effects and natural fluctuations in
severity, a control group is necessary before any inference of
treatment effectiveness can be made.
How Can
the Existing Studies Guide Clinical Practice?
Based on
the available literature, there is little to suggest that massage
may be harmful or contraindicated for people with diabetes. However,
common sense can prevent potential problems. Clinicians wanting
to refer people with diabetes for massage should keep three things
in mind.
First, clinicians
should provide guidance to insulin- or sulfonyureatreated patients.
Specifically, these patients should monitor their blood glucose
levels carefully before and after massage to watch for decreases.
If pre-massage blood glucose levels are low or normal (<120
mg/dl), patients may wish to eat something before their massage.
A blood glucose taken immediately after massage can guide patients
about whether the amount they ate was appropriate. If pre-massage
blood glucose levels are high enough to use supplemental insulin,
patients may wish to use a less-than-usual amount of insulin before
massage.
For these insulin- or sulfonylureatreated
patients, monitoring blood glucose three to four times a day (fasting,
before lunch, before dinner, and before bedtime) can provide insight
into how massage may affect blood glucose and aid in determining
whether medication changes are needed. As with exercise guidelines,
patients should be instructed not to schedule massage during the
peak of insulin activity. For intermediate-acting insulins (lente
or NPH) injected at breakfast, this would be approximately 8 h
later, in mid-afternoon. For rapid-acting insulins (lispro or
aspart) or short-acting insulin (regular), this would be anywhere
from 1 to 3 h after injection.
Second,
clinicians may wish to suggest a practitioner who is trained in
Swedish massage, given that most of the identified massage research
has utilized this massage technique.
Third, because
some states require no credentialing of massage therapists, a
massage therapist holding a national certification from the National
Certification Board of Therapeutic Massage and Bodywork or the
American Massage Therapy Association would be preferred.
Massage
therapists can exercise caution by ascertaining during the initial
phone conversation whether a person has diabetes and, if insulin
is used, when and where it is generally injected. Massage therapists
should book treatments when insulin is not at its peak activity.
How Can
the Existing Studies Guide Future Research?
Insulin
injection-site massage compared to no massage in people with type
1 diabetes appears to increase blood levels of insulin and decrease
blood glucose. (30) A next step would be to examine whether massage
can be used in type 1 diabetes to reduce and stabilize blood glucose.
Another research issue would be to examine whether massage can
augment tissue insulin sensitivity similar to exercise (36) in
people with type 2 diabetes so that endogenous insulin can be
used more efficiently.
Before a
large randomized trial is conducted, potential mechanisms of action
should be explored, and an optimal massage protocol should be
established. This can be accomplished through a series of small
pilot studies. Efficacy, by definition, is the assessment of an
optimal treatment under ideal conditions, and an optimal massage
treatment protocol for diabetes needs to be systematically and
scientifically developed.
Specific characteristics
of the massage protocol that would need to be examined in pilot
studies would include the relative contribution of 1) body surface
area, 2) depth of massage, 3) rate of massage, 4) duration of
treatment, and 5) frequency of massage administration on outcomes
of insulin sensitivity (measured by insulin clamp analysis), blood
glucose levels (measured three to four times per day and also
measured by fructosamine for a 2-week average glucose measure),
and the relaxation response (measured by heart rate, blood pressure,
self-report, and salivary cortisol).
Depression
and sense of well-being should also be measured. People with diabetes
experience a fourfold elevation in the risk of depression over
the general population, although the reasons are not well understood.
(37) The massage studies measuring depression (25-27) noted that
depression improved. The unpublished study (M.C., unpublished
observations) showed improvements in sense of wellbeing. If these
findings are replicable in controlled trials, this would be an
important contribution of massage to diabetic patients independent
of blood glucose effects.
Pilot studies
may also allow observation of potential drug-massage interactions.
For example, massage may have a harmful interaction with insulin
and sulfonylureas, which can cause hypoglycemia, whereas massage
may interact in a therapeutically positive way with insulin-sensitizing
drugs.
In pilot
studies, one could also look at duration of response and whether
there are any preliminary trends suggesting that massage can assist
in normalizing glucose levels. One could also investigate whether
there is a glucose level above which massage would be detrimental.
For example, patients with diabetes are typically encouraged not
to exercise when blood glucose levels are >250 mg/dl for fear
of causing these levels to rise even higher. This is because the
gluconeogenic effect of catecholamines appears to predominate
when patients are hyperglycemic--a time when ambient insulin levels
are low. This would not be anticipated to occur in patients receiving
massage therapy because counterregulatory hormones would not be
expected to increase; however, this remains an unexamined possibility.
Following
are potential research questions related to specific characteristics
of massage. These would need to be studied while holding all of
the other characteristics constant.
Surface
area. A major question exists about whether a full-body massage
that covers a maximal surface area should be the optimal treatment
or whether massage of the large muscle groups would be sufficient
or even preferred. (38) This could be tested by comparing two
randomly assigned groups: one that receives a full-body massage
and the other that receives massage of just the large muscle groups
for the same time period.
Depth of
massage. If massage pressure is partly responsible for increased
absorption at injection sites, then it may also be true that pressure
plays some role in increasing insulin sensitivity of the tissues.
If that is so, then deeper treatments, such as those provided
in neuromuscular therapy, (19) might be more effective than the
milder pressure of a Swedish massage for those without progressive
disease. This could be tested by sing the same massage techniques
(i.e., friction, effleurage, and petrissage) and altering only
the pressure.
Rate of
massage. It has been suggested that decreases in blood glucose
may, in part, be modulated by interstitial exchange. (34) If that
is so, then a quick hand motion might maximize interstitial exchange.
On the other hand, if decreases in blood glucose occur primarily
through the relaxation response, one would opt for slow stroke
techniques s that induce that response. (24)
Duration
of treatment. Given the same type of massage, is 60 min of massage
superior to 30 min? If it is found that there is no additional
benefit to be gained in the 60-min group, then this has implications
for devising an optimal, yet cost-effective dose. If there is
an additional benefit, then a 30-min treatment in efficacy trials
might be considered a suboptimal dose.
Frequency of treatment.
Massage can be administered on a weekly or even daily basis. What
is an optimal therapeutic frequency? Kurashova (32) suggests that
twice-weekly massage can be beneficial for people with diabetes.
This remains to be examined.
Duration of benefit, possible
cumulative effects, and therapeutic versus maintenance dosing.
There is little in the literature to suggest how long a treatment
effect may last. Although it may not be practical to keep patients
hooked up to an insulin clamp to determine duration of benefit,
monitoring blood glucose several times a day would provide some
insight. Additionally measuring fructosamine would provide a 2-week
average of potential benefits on blood glucose. If benefit is
noted, then one could examine whether treatment effects last longer
with more treatments (cumulative effects), a trend one would wish
to see if massage truly assists with normalizing blood glucose.
If there is some evidence of a cumulative effect, then one could
explore whether a less-frequent maintenance dose can sustain benefits
in responders.
Selection of population.
The justification for the selection of a study population should
be well considered. Because the potential risks and benefits may
vary according to whether a patient has type 1 or type 2 diabetes
and whether a patient uses hypoglycemic medications, a homogeneous
study population is suggested. For example, a study sample of
people with relatively well-controlled type 2 diabetes could help
determine whether increased insulin sensitivity results from massage
and whether this can translate into changes in insulin or hypoglycemic
medication doses.
Regardless
of the population sample, the selection of a homogeneous population
is preferred because investigators should not assume that the
same type of massage may be equally efficacious for all groups.
Different exercise regimens are needed for different groups of
people with diabetes, (36) and this point should be well taken
in massage research. A pilot population that is too heterogeneous
may fail to identify benefit in a specific subgroup.
Once an
optimal treatment protocol has been established, that protocol
can be used in a larger, randomized controlled trial. In the selection
of an optimal treatment, one should also have determined a least-
or less-optimal treatment protocol as a control group.
A randomized,
controlled trial could involve three arms: the optimal treatment,
the least-optimal treatment, and a delayed treatment or waiting-list
control. The waiting-list control would provide insight on natural
fluctuations in the outcome measures in this population but would
not measure placebo effects. The least-optimal massage group could
control for placebo effects.
Because
even a least-optimal massage treatment may elicit some nonspecific
physiological effects that are beyond the placebo effect, it is
imperative to be sure in advance that the least-optimal massage
treatment protocol will not physiologically approximate the optimal
massage treatment. Administering two physiologically similar massage
treatments would greatly narrow between-group differences causing
huge increases in sample size requirements or, if ample sample
size is not anticipated in advance, leading to a type II (false-negative)
error.
Any randomized trial should
provide treatment for at least 3 months. This would permit changes
to become evident in the [HbA.sub.1c]. Trials measuring [HbA.sub.1c]
should also have a 2-month lead-in period during which values
are measured but no intervention is given in order to obtain valid
baseline measures.
Changes in [HbA.sub.1c]
may demonstrate whether massage may, in fact, be able to alter
disease outcome. The sample size for a large, randomized controlled
trial, therefore, should be calculated based on a clinically important
change in [HbA.sub.1c]. A 1% decrease in [HbA.sub.1c] reflects
a 30 mg/dl decrease in blood glucose.
Further
research is also needed regarding the uses of massage for diabetic
neuropathy. To date, no trials assessing manually applied massage
have been reported. The positive results of the mechanical syncardial
massage trial offer a proof of principle that massage may be beneficial
in diabetic neuropathy, but clearly more needs to be done to understand
the potential benefit, possible mechanisms of action, and contraindications
of manually applied massage. By assessing outcomes used in other
diabetic neuropathy trials, (35) one can explore whether massage
can be beneficial in neuropathy as well as explore which massage
techniques (effleurage versus petrissage versus friction) are
of optimal benefit.
SUMMARY
Massage
at an insulin injection site can significantly
increase serum insulin action, thereby decreasing blood glucose
levels in people with type 1 diabetes. We do not know whether
massage can improve insulin sensitivity and therefore be a useful
adjunct to the management of diabetes for those with type 2 diabetes.
Uncontrolled studies suggest
that massage may help normalize blood glucose and symptoms of
diabetic neuropathy. Randomized, placebo-controlled studies are
needed to further clarify what an optimal massage treatment might
be and to elucidate any short- and long-term benefits of massage
as a complementary treatment for diabetes.
'Acknowledgment
We would like to thank
Richard Va Why for his assistance in identify in relevant studies
an or making the Bodywork Knowledge Base available for this project.
Jeanette Ezzo, MsT, MPH
PhD, an epidemiologist, is research director of JPS Enterprises
in Tokoma Park, Md., and a practicing massage therapist in Baltimore,
Md. Thomas Donner, MD is an assistant professor of medicine in
the Division of Endocrinology, Diabetes, and Nutrition at the
University of Maryland School of Medicine in Baltimore. Diane
Nickols, BS, PA-C, is the regional manager of training and development
at MedQuist Mid-Atlantic in Columbia, Md. Mary Cox, Ms T, BS,
is the research director of the Baltimore School of Massage in
Baltimore, Md.
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Diabetes Association
