MEDICAL STUDIES
Baylor University Medical Study
Response of Pain to Static Magnetic Fields in Postpolio Patients: A Double-Blind
Pilot Study
Carlos Vallbona, MD, Carlton F. Hazlewood, PhD, Gabor Jurida,
MD Archives of Physical Medicine and Rehabilitation Baylor University, College
of Medicine Houston, Texas ------------------------------------------------------------------------
POSTPOLIO SYNDROME is a well recognized clinical entity which, since
the early 1980s, has generated an abundant scientific literature (a Medline
search found 88 references from 1981 to 1996; 24 of the publications included
pain as a key word). The clinical manifestations are either very specific (eg.
increasing muscle weakness on previously affected or unaffected muscles, muscle
fasciculation's) or somewhat unspecific (eg, fatigue, pain).
The pain reported by postpolio patients can generally be categorized as either (1) myofascial, which can be elicited in various muscle groups, or (2) arthritic, which is evident on active or passive mobilization of several joints.1 In the initial report about the postpolio syndrome by Halstead and coworkers,2 the prevalence of pain among polio survivors who responded to a questionnaire was 75.5%. Subsequent reports confirm that many types of pain are experienced by postpolio patients, but most include diffuse muscle and joint pain.1,3-5 In our experience with more than 1,000 patients diagnosed with postpolio syndrome at a postpolio clinic, pain is reported by almost all patients.
Pain in the joint is thought to result from degenerative arthritis caused by age and by longstanding asymmetrical load on the joints as a result of the asymmetrical skeletal muscle paresis or paralysis produced by poliomyelitis. The most common type of joint pain is referred to the low back, the cervical column, and the sacroiliac joint. The last-named may be reported as diffuse low back pain but can be readily localized through palpation of a specific trigger point located above the sacroiliac joint. Hip and shoulder pain are also prevalent.
The muscular type of pain can be objectively elicited by palpation of the reported sore muscles and by identifying specific trigger points associated with tlie referred pain. The atlas of trigger points provided by Travell and Simons6,7 is of great aid in the search for such trigger points. Symptomatic cervical arthritis may be accompanied by a considerable degree of tight ness of the neck muscles with trigger points in the sternocleidomastoid, scalenus, and trapezius areas.
Regardless of the type of pain, postpolio patients have increased
sensitivity to receptive stimuli,8 and this may explain why they report pain
so often. In spite of its prevalence the available treatment for it is limited.
Currently, recommended modes of treatment are rest; traditional modalities of
physical therapy (heat, cold, ultrasound, transcutaneous electrical neural stimulation
[TENS] ); use of a support brace; or administration of muscle relaxants, analgesics,
or anti-inflammatory agents. The effectiveness of pharmacological agents is
generally poor, and in some instances (eg. use of aspirin or nonsteroidal anti-
inflammatory drugs) there arc undesirable side effects. Other modalities of
pain management such as meditation, yoga, or hypnosis have not given our patients
consistent relief.
The limited success in pain management prompted us to explore
alternative methods of pain management. Static and fluctuating electromagnetic
fields have been applied with apparent success for the management of pain in
a variety of orthopedic conditions, most commonly traumatic bone fractures or
surgical osteotomies.9-11 As early as 1938, Hansen12 reported the effectiveness
of electromagnetic fields (which had "a carrying power of from 8.5 to 14
kg") applied for 1 to 15 minutes. Twenty- three of 26 patients with complaints
of "sciatica," "lumbago," and "arthralgia" reported
rapid and significant relief of their pain. The study was not double-blinded,
but the author reported no pain reduction in two patients to whom the electromagnetic
device was applied without the electricity being turned on. In osteoarthritis,
double-blind, placebo-control studies have shown the efficacy of a pulsed electromagnetic
field.13,14 Carpenter and Ayrapetyan15 provide an excellent overview of the
biological effects of electromagnetic fields. The literature continues to grow
from earlier reports,16-18 building on futtlier efforts to Scientifically document
the impact of magnetic fields on biological systems.19-22 The safety of application
of these electromagnetic fields is attested by the World Health Organization,23
which reported: "The available evidence indicates the absence of any adverse
effects on human health due to exposure to static magnetic fields up to two
Tesla" (2T = 20,000 Gauss).
Static magnetic fields can be delivered by placing magnets
of different field strengths on the skin over the affected areas. These magnets
usually vary in strength from 300 to 5,000 Gauss. The magnets can be kept in
place with adhesive tape. A variety of magnets are commercially available. Frequently,
significant pain relief has been observed less than 30 minutes after placement
of the magnets.24 Anecdotal reports of the benefits of permanently magnetized
devices abound (even in postpolio patients who had reported pain relief to us
before our study). Nakagawa, 25 in a technical bulletin, reported a decrease
of neck and shoulder pain after use of a loosely fitted magnetically active
necklace. However, Hong and associates19 did a double- blind study of the long-term
effect of a similar device on some physiologic parameters (nerve conduction
velocity and excitation threshold) in a group of 101 volunteers, but did not
find any significant pain relief in the 52 who had reported chronic neck or
shoulder pain before the study when compared with the 48 who had not reported
pain.
To our knowledge, static magnetic fields (electromagnetic
or permanently magnetized devices) have not been scientifically tested on postpolio
survivors. Consequently, we completed a double-blind pilot study on patients
at our clinic who reported significant muscular or arthritic-type pain.
METHOD Subjects
We recruited 50 patients with postpolio syndrome who reported muscular or arthritic pain and who consented to participate in the study. The diagnosis of the postpolio syndrome was made according to well-established criteria.5, 26
The patients selected for the study had significant pain for at least 4 weeks,
had not taken an analgesic or similar drug for at least 3 hours before the study,
had a trigger point or a circumscribed painful region by palpation, and had
body weight less than 140% of predicted for age and height. Patients were required
to remain in the clinic for 1 hour after the scheduled visit with the postpolio
team. Only five of the patients invited to participate refused; four could not
stay at the clinic for the additional required time and one refused because
of concern about side effects.
The consent form given to the patients stated the purpose of the research. No explanations were given as to expected responses but patients were told that the level of pain would be assessed by palpation of a trigger point before and after application of the device.
Table 1 summarizes the characteristics of these patients recording to the group to which they were randomized (magnetic treatment or placebo).
Table 1: Characteristics of Study Patients
Active Magnetized Device
Inactive Device
No. of subjects
29
21
Age (mean+-SD)
51.5 +- 9.6
55.9 +- 9.7
Sex (F:M)
24:5
15:6
Race ethnicity (W, B, H, A)*
22, 1, 6, 0
18, 2, 0, 1
Weight (mean +- SD)
151.59 +- 31.05
151.79 +- 34.76
Age at onset of poliomyelitis (mean yrs +- SD)
6.34 +- 5.72
7.17 +- 6.79
Age at onset of postpolio syndrome (mean yrs +- SD)
42.84 +- 7.44
44.41 +- 7.10
Type of treated pain (M/A)
52%/48%
43%/57%
*W, White; B, African-American; H, Hispanic; A, Asian,
Muscular; A, Arthritic.
Treatment Intervention The specific devices used were the Bioflex magnets with
a pattern of concentrically arranged circles of alternating polarity. The company
made available to us 8 discs 40mm in diameter, l.5mm thick; 18 discs 9Omm in diameter,
1.5mm thick; 20 credit-card-sized pads, 83 X 53mm, 1.5mm thick; and 24 strips,
175 x 50mm, thick. The magnetic fie Id intensity of the active devices was rated
at 500 Gauss at the surface for the 40-mm disc and the strips. The 90mm discs
and the credit-card pads were rated as 300 Gauss at the surface of the device.
The manufacturer supplied us with an equal number of the active and placebo devices
of identical size and shape. Each device was placed in a number-coded envelope,
and all devices were delivered to us in four separate boxes according to device
shape. The code numbers identifying active and placebo devices were not broken
until all patients completed the study.
After the patients gave their written consent, they were asked
to complete a McGill Pain Questionnaire to provide a subjective evaluation of
their general pain experience. In this study, only one area of reported pain was
evaluated, even though multiple sites may have been present. An active trigger
point associated with thc site of referred pain was grossly elicited first by
finger palpation and then identified by firm application of an object approximately
1cm in diameter, which in non painful areas produced a sensation of pressure but
no pain. The subject was asked to subjectively grade the pain at the trigger point
on a scale from 1 to 10 (with 1 being the least and 10 being the maximum). When
patients reported pain in more than one area, the area most sensitive to palpation
was selected.
The pain scale used in this study had been previously validated27 and is particularly applicable to patients with disabilities. Depending on the area involved, we used either a disc, a credit-card-sized pad, or a strip-shaped device. An envelope containing a device of the appropriate shape was randomly selected from a box and applied to the skin with adhesive tape. Each patient was then asked to remain in the clinic or immediate clinic area, to keep thc device in place for thc next 45 minutes, and assume whatever position was most comfortable, including walking. After 45 minutes, the device was removed, and the patient was asked to report whatever sensations were felt after the application of the device. Again, the patient was asked to assess the intensity of the pain felt on palpation of the active trigger point associated with the referred pain site. The same scale of 1 to 10 was used. Although we did not measure the exact pressure exerted by the blunt object at the trigger point before and after the study, the investigators tried to be as consistent as possible on the amount of applied pressure. There was no systematic follow-up of patients after the application of the device, but in many cases we obtained information at the time of the patient's next visit to our clinic. Back to top
RESULTS
Table 1 shows the characteristics of the study participants. There was no significant difference in any of the variables that described the two groups. There was a much greater proportion of women than men in both groups (the women-to-men ratio of the participants in the study is 'slightly higher than the rat for our clinic's population).
The race-ethnicity distribution of the participants parallels that of the postpolio
clinic patients. The age of onset of poliomyelitis and the age of onset of the
postpolio syndrome were almost identical in both groups. Since the time of onset
of thc postpolio syndrome cannot always be clearly established, the data in the
table should be considered estimates only. The classification of the type of pain
as predominantly muscular or predominantly arthritic is somewhat arbitrary because
arthritic changes are often accompanied by muscular spasm with clearly distinguishable
trigger points. An distribution of the location of pain where the active or inactive
magnetic devices were applied did not show any significant difference between
the two groups. The sacroiliac joint was the most common location for both group
(41% of those who received the magnetized device and 33% of those who received
the inactive device).
Table 2 shows the mean and standard deviation of the pain scores before and after application of the device in the two groups of subjects.
Table 2: Pretreatment and Post treatment Pain Scores
Active Magnetized Device
Inactive Device
Significance
No. of Subjects
29
21
Pretreatment Pain Score (mean +- SD)
9.6 +- 0.7
9.5 +- 0.8
NS
Post treatment Pain Score (mean +- SD)
4.4 +- 3.1
8.4 +- 1.8
p < .0001
Change in Pain score (mean +- SD)
5.2 +- 3.2
1.1 +- 1.6
p < .0001
The pretreatment score was almost identical in both groups of subjects, but there
was a highly significant difference between pre-treatment and post treatment scores
in the two groups. Those who received the active device reported much less pain
than those who had the inactive device.
It is of interest to examine the proportion of patients in each group who reported improvement in pain intensity. Since the average decrease of pain score was 1.1 (+/- 1.6) in the subjects who received the inactive device, we decided to dichotomize changes in pain scores as "improved" if the score decreased by 3 points or more and "not improved" if the decrease was less than 3 points. As shown in table 3, 22 patients (76%) in the active-device group showed improvement, compared with only 4 (19%) in the inactive-device group.
Table 3: Proportion of Subjects Reporting Pain Improvement by
Magnetic Activity of the Treatment Device
Active Magnetized Device
Inactive Device
(n=29)
(n=21)
Pain Improved
n=22 (76%)
n=04 (19%)
Pain not Improved
n=07 (24%)
n=17 (81%)
X2 (1 df ) = 20.6 (p <.0001)
This difference is highly significant (p < .0001). Also, the average score decrease in the four patients who had a placebo effect was 4 points versus 7 for those who had a treatment effect. DISCUSSION
The results of this randomized pilot clinical trial show that
static magnetic fields of an intensity of 300 to 500 Gauss are effective in the
control of pain in patients with the postpolio syndrome. Whether the pain was
of a myofascial or arthritic nature, it seemed to respond equally well to the
static magnetic field and the effect was noticed within 45 minutes from the onset
of the application. Back to top
We must point out that we studied the effect of the static magnetic fields in one painful area only on each subject and did not attempt to quantify the potential impact of such field on other painful areas that may have been present on the same patient. Interestingly, some patients recorded benefit derived from the magnetic field in other areas. This effect was reported mostly in the patients who had pain in both sacroiliac joints, in which case we always applied the device on the one that was most sensitive to palpation.
The intensity of the applied magnetic fields was rather low
in relation to that applied in other studies, and we did not attempt to assess
a dose-response effect. It is likely that the level of penetration of the magnetic
field is related not only to the magnet's intensity, but also to the distance
between the superficial area to which the device is applied and the site of the
trigger point that lies on the fascial plane of a muscle, tendon, or joint. Because
of this, we excluded from the study very obese patients or those who had a significant
amount of subcutaneous fat overlying the trigger point associated with the painful
area. The fact that Hong22 did not find evidence of effect in his double-blind
study of a loose magnet necklace may be due to the small delivered magnetic intensity
of the device, which was not directly applied over specific pain trigger points.
We cannot explain the significant and quick pain relief reported
by our study patients. The effect could result from a local or direct change in
pain receptors, but it is also possible that there was an indirect central response
in pain perception at the cerebral cortical or sub cortical areas, or a change
in the release of enkephalins at the reticular system. If the magnetic fields
have an impact on the sub cortical level of the brain, it is possible that the
application of one magnetic device in one painful area may benefit to a greater
or lesser extent the pain elicited in other trigger points This is an issue that
requires further study. Bruno and colleagues8 have pointed out the existence of
lesions in various areas of the brain of poliomyelitis survivors, and they believe
that these lesions may explain the hypersensitive response to painful stimuli
that they have observed in postpolio patients. This should not be interpreted
to mean that the relief of pain produced by magnetic fields that we observed was
specific for postpolio patients because similar responses to magnetic fields have
been reported in patients without known lesions of the central nervous system.12
Even so, our understanding of pain and pain relief is far from complete.
Insofar as we can determine from the literature, this double-blind
placebo-controlled study using permanent magnets in a bipolar configuration directly
applied to trigger points may be the first reported. This study coincides with
mounting evidence that magnetic fields interact in significant ways with biological
tissues. The exact mechanisms of the interaction of magnetic fields with biological
tissues resulting in functional changes are unknown.28, 29 This is particularly
true for our understanding of the pain relief associated with the application
of a magnetic field to trigger points as demonstrated in this study. Much progress,
however, is being made in the field of Bio-Electro-Magnetics, in both the experimental
studies and theoretical concepts. Several of these concepts (some old and some
new) appear to30-35 be promising; certainly. they are ultimately testable.
We are interested in the possible role of water in the pain mechanism, and attempts
will be made to evaluate the physical basis of this idea using magnetic resonance
technology. It is now clear that water is organized in space and time,36 and in
a human study conducted by onc of us (C.H.),37 subjective pain relief was associated
with a shift of T-cells into the S-phase. Beall and colleagues38 demonstrated
cyclical changes in the physical state(s) of water with the water being most organized
in the S-phase. That water plays a major role in explaining the therapeutic effects
of magnetic fields has also been proposed by others.15
The fact that none of our patients reported any discomfort
resulting from the use of magnetic devices and that no complications have been
reported in the literature supports the notion that low-intensity magnetic fields
produced by permanent magnets or electromagnetic devices are biologically safe.
CONCLUSIONS
The delivery of static magnetic fields through a magnetized
device directly applied to a pain trigger point or to a localized painful area
results in significant relief of pain within a short period of time (less than
45 minutes in our study) and with no apparent side effects. Based on the results
of this study and reports in the literature of the effect on people with arthritis,
it appears that magnetic field energy may he useful in the management of pain
in individuals with other types of impairments that are commonly treated in primary
care settings.
Specific issues that need to be explored through new studies
are: (1) dose-response to pain relief; (2) duration of the effect after applying
a static permanent magnetic field; (3) identification- don of the local and central
effects of magnetic fields on the same pain area; (4) effect of the simultaneous
application of magnets on several pain trigger areas; (5) possible difference
of effect of various sizes and shapes of a magnetized device; and (6) cost effectiveness
of pain management with magnetic fields versus traditional pharmacological or
physical therapy modalities. Back to top
Acknowledgments: The authors are indebted to Valory Pavlik,
PhD, for her assistance in the study design, the statistical analysis of the results,
and the review of the manuscript. Mandy Smith, PT, contributed to the selection
of patients. Mrs Christine Toronjo was responsible for the processing of data.
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