The Efficacy of
Farabloc™ in the Treatment of Phantom Limb Pain
Canadian Journal
of Rehabilitation Volume 6, Number 3, 993 pp. 155-161 ISSN 0828-0827
Printed in Canada. All Rights Reserved.
© Copyright held by Canadian Association for Research in Rehabilitation 1993
Tali A. Conine,
DHSc, PT; Cecil Hershler, MD, PhD, FRCP(C);
Steacy A. Alexander, BSc, PT; and Robert Crisp, BSc, PT
The assistance of Mr. Wayne
Jones, statistical analyst, and Ms. Salima Jeraj, research assistant, is
gratefully acknowledged. This study was carried out by the University of British
Columbia under a contract ordered the British Columbia Ministry of Health,
1990-1992.
Farabloc is a product promoted
for the relief (not cure) of intermittent phantom limb pain. It is a linen
fabric with ultrathin steel threads to be worn over the stump and claimed to
shield nerve endings from external electrical and magnetic fields. In a double
blind, cross-over design, 34 subjects reported their pain relief level on a
Visual Analogue Scale during a pretreatment period, Farabloc or placebo
treatment period, a no-treatment or "washout" period for the control of any
carry-over effect, and an alteration of treatment period. The results were
statistically significant (p < .001) in favour of the Farabloc period. Of the 34
subjects, 21 reported their greatest pain relief during Farabloc intervention.
However, the clinical significance of the findings may be questioned since only
two subjects reported complete or near complete pain relief with Farabloc, and
the number of potential users is limited. Nevertheless, Farabloc is a relatively
inexpensive alternative compared to other therapeutic measures currently
available.
Phantom limb pain is one of the
most distressful sequela of amputation, affecting a majority of persons with
healed stumps, often persisting for years or decades (Jensen, Krebs, Neilson, &
Rasmussen, 1985; Sherman, Sherman & Parker, 1984). It is commonly described as a
sensation of a twisted absent limb, hyperflexed absent fingers or toes digging
into the palm or plantar surface, or as burning, cramping, crushing, shooting,
or stabbing sensation in a missing body part. The pain may last for a few
minutes, hours or days, occasionally or continuously over a long period. The
episode in some persons may be triggered or intensified by unrelated pain (e.g.,
back pain) or by gentle pressure of the stump, other limb, or head. Urination,
defecation, sexual intercourse, or approaching low pressure weather systems
could also act as triggers. Although research suggests a physiological basis for
the pain, the etiology of phantom limb pain is unknown. Its incidence has not
been associated with the reason for the amputation, location of amputation, age,
gender, socioeconomic status, or a psychological disorder.
In a 1980 report more than 50
unrelated treatments for phantom limb pain were identified by Sherman, Sherman,
and Gall. These include surgical interventions (e.g., sympathectomy, rhizotomy),
pharmacological approaches (e.g., nerve blocks, local anaesthetics), physical
therapy (e.g., ultrasound, TENS), and psychological treatments (e.g.,
psychotherapy, biofeedback, hypnosis). Unfortunately, none of the described
methods has been successful for more than a year's treatment duration with more
than one third of patients, the same as placebo use in pain management (Evans,
1974).
In recent years, FarablocTM, a
proprietary product (Farabloc Development Corporation, Port Coquitlam, B.C.),
has been widely promoted in Europe and North America for the relief of
intermittent (not constant) phantom limb pain. Farabloc is made of a series of
ultrathin steel threads woven, in a specific pattern, into a linen fabric which
can be sewn into a garment (e.g., a sleeve/glove, sock, vest) to be worn over
the amputation site as soon as the pain is felt. It is based on the same
principle as the "Farady Cage" to block external magnetic influences.
No control trials have been
reported in the literature of its efficacy. In late 1990, the British Columbia
Ministry of Health requested that we evaluate Farabloc. It was hypothesized that
the use of Farabloc would have no statistically significant effect on the
intensity of the phantom limb pain experienced by persons with limb amputations
(p < .05).
METHOD
Materials
For the purpose of this study,
the manufacturer produced a placebo fabric, identical to Farabloc in colour,
thickness, and texture but without the wire mesh which is not visible. Garments
were fashioned from each fabric as appropriate for the individual subject.
The manufacturer recommends
that Farabloc be used for episodic (not constant) pain. The garment is worn for
four or more hours, as soon as the pain begins, in two or three layers over the
stump and extending 10 to 15 cm beyond the amputation scar. If other scar tissue
or unrelated painful parts exist (e.g., burn scars, arthritic joints) these
areas, too, should be covered by the material. For this study, additional
garments were made for the subjects as needed to cover other scars or painful
body parts. The garments made from Farabloc or placebo fabrics were coded.
Farabloc is non-irritant to the
skin. Normal machine washing and drying may be safely used.
Subjects
The subjects were consenting
adults with upper or lower extremity amputations and healed stumps, experiencing
episodes of phantom limb pain (not constant pain) who were referred to the study
by their physicians, prosthetists, or rehabilitation therapists. None of the
subjects were associated with the authors as their patients.
To qualify for the study,
subjects had to be (a) 19 years of age or older; and (b) able to comprehend
English, grant informed consent, and understand the use of a Visual Analogue
Scale (VAS) to report pain relief (Huskisson, 1983); and (c) able to keep a log
for recording each pain episode (i.e., date, time, and duration of pain, and
time when garment applied, duration of wear). Subjects were excluded if they:
(a) had stump complications (e.g., skin irritation); (b) were undergoing new
treatments; (c) were involved in a compensation claim; (d) had problems with
their prosthesis; (e) had changed their normal use of the prosthesis or obtained
a new prosthesis; or (f) had a diagnosis of neurological or psychological
disorder.
Instruments
The subject was asked to
describe the degree of pain relief that was experienced after each episode of
phantom limb pain by marking the VAS. This instrument uses a 10 cm line with
"stops" at each end and a description written "no pain relief" on one extreme
and "complete pain relief" on the other (Huskisson, 1983). The subject marks a
point on the line to correspond with the magnitude of his pain relief. The
distance of the mark from the endpoint is measured for a quantitative
measurement of pain. The VAS was chosen because it is simple to use, its
validity has been established based on high correlations with other standard
measures of pain and medication usage, and its reproducibility is as high as
0.99 (Scott & Huskisson, 1979; Jensen, Karoly, & Bravor, 1986; Wall,
Novotny-Joseph, & MacNamara, 1985).
To estimate pain relief, the
subjects were also asked to record the time, date and duration of each pain
episode, and the time and duration of the use of the garment provided to them.
Procedures
This study was a sequential,
double blind, crossover design composed of a pretreatment period, random
assignment to the use of Farabloc or placebo treatment period, a "wash-out" or
no treatment period for the control of any possible carry-over effect of
treatment, and a crossover period involving the alteration of treatment. Each of
these segments covered a duration of three to five consecutive episodes of pain.
One of the authors (CH)
screened the referred candidates for the inclusion/exclusion criteria. Another
author (TAC) obtained the informed consent, explained the procedures, and
assessed the ability of the subjects to use the VAS and the log. Following the
pre-treatment period and based on a predetermined randomized schedule, a
departmental secretary provided the subject with a Farabloc garment, or a
placebo garment with verbal and written instructions for use. Additional
garments were provided, as needed, for other pain or scar sites.
The subject was unaware of the
sequence of the presentation of the materials. A research assistant, also blind
to the material in use, periodically followed up each subject to ensure
compliance with the protocol, to monitor the rotation patterns for each period,
and to collect the data which were then forwarded to an independent statistician
for analysis. The subjects were instructed to feel free to use their usual
medications or analgesics at any time during the trial as prescribed by their
physicians, and to continue any other method of pain control to which they were
accustomed (e.g., relaxation, removal of the prosthesis, use of a heating pad,
or tapping the stump).
RESULTS
Fifty-two persons with
amputations who met the criteria were referred to the study. Of these, 34
completed the trial. The others (18) were not included, or were removed from the
study, because they: experienced pain too infrequently (less than 15 episodes
per year) to participate within the study's time frame (6), found the garment
uncomfortable (6), were unable to maintain the log or wear the garment as soon
as pain was experienced (4), had a new prosthesis (1), or had an unrelated
surgery (1).
Of the 34 sequentially
randomized participants, 18 began the treatment with Farabloc (Group 1) and 16
with the placebo (Group 2). The characteristics of the two groups were quite
similar (see Table 1). None of the subjects was addicted or used narcotics,
antidepressants, anticonvulsants, neuroleptics, or other prescription agents for
pain relief. During the trial, none reported any allergic or other problems
associated with the use of Farabloc.
Table 1.
Characteristics of the 34
subjects who completed the trial.
|
Characteristics
|
Group 1 Farabloc -Placebo
(N=18)
|
Group 2 Placebo - Farabloc
(N=16)
|
Sex: male / female |
15
/ 3 |
13
/ 3 |
Age |
46
years (sd =8.2) |
43
years (sd=8.9) |
Education |
8
years (sd=4.0) |
8
years (sd=3.5) |
Time since amputation |
1
to 40 years |
2
to 31 years |
Location of amputation: |
Above knee |
4 |
6 |
Below knee |
8 |
6 |
Above elbow |
2 |
3 |
Below elbow |
2 |
1 |
Index and thumb |
0 |
0 |
Shoulder disarticulation |
1 |
1 |
Reason for amputation |
Trauma |
12 |
10 |
Vascular |
5 |
4 |
Cancer |
1 |
2 |
Description of pre-dominant
pain: |
Burning |
5 |
4 |
Cramping |
4 |
4 |
Electric shock |
2 |
2 |
Stabbing |
3 |
2 |
Shooting |
1 |
1 |
Pins and needles |
1 |
2 |
Ants crawling |
1 |
0 |
Unnatural position |
1 |
1 |
Table 2 shows each subject's
averaged pain relief scores for three to five episodes of pain during each
period. In all, 21 subjects reported their greatest pain relief during Farabloc
intervention (11 or 61% in Group 1; 10 or 62% in Group 2). However only one of
these subjects in each group shows complete (VAS = 10) or near complete (VAS =
9.8) pain relief with Farabloc. One subject in Group 2, subject #5, appears to
have had greater pain with both placebo and Farabloc.
Table 2.
Pain relief
rating scores using the Visual Analogue Scale by 18 subjects in the Farabloc-Placebo
(Group 1)
alteration of treatment and by 16 subjects in the Placebo-Farabloc (Group 2)
alteration of treatments. |
Group 1
|
Pre-treatment
|
Farabloc
|
Washout
|
Placebo
|
1
|
0.0
|
0.8
|
2.0
|
1.0
|
2
|
0.0
|
4.8
|
0.0
|
2.8
|
3
|
1.1
|
0.4
|
0.5
|
1.5
|
4
|
2.0
|
2.0
|
2.1
|
3.1
|
5
|
1.0
|
3.6
|
2.0
|
2.2
|
6
|
2.3
|
7.0
|
2.0
|
3.1
|
7
|
0.2
|
8.1
|
0.5
|
3.1
|
8
|
2.0
|
4.7
|
1.9
|
4.0
|
9
|
0.3
|
5.8
|
0.0
|
2.4
|
10
|
3.2
|
9.8
|
2.9
|
4.8
|
11
|
1.2
|
0.3
|
0.5
|
0.4
|
12
|
1.1
|
3.5
|
2.0
|
0.0
|
13
|
2.8
|
1.8
|
3.0
|
2.1
|
14
|
0.3
|
3.2
|
3.0
|
3.2
|
15
|
2.5
|
6.0
|
1.2
|
2.5
|
16
|
0.0
|
3.8
|
0.0
|
1.5
|
17
|
2.0
|
5.2
|
2.2
|
3.8
|
18
|
0.0
|
0.5
|
2.0
|
1.0
|
Group 1
|
Pre-treatment
|
Placebo
|
Washout
|
Farabloc
|
1
|
1.1
|
0.8
|
2.0
|
1.0
|
2
|
0.8
|
1.0
|
1.0
|
3.0
|
3
|
1.8
|
2.0
|
2.0
|
0.6
|
4
|
0.9
|
3.8
|
4.9
|
6.0
|
5
|
1.2
|
0.0
|
2.0
|
0.0
|
6
|
2.1
|
7.0
|
3.0
|
6.7
|
7
|
3.2
|
3.0
|
2.9
|
4.7
|
8
|
1.0
|
0.0
|
0.0
|
1.5
|
9
|
0.0
|
5.2
|
2.9
|
7.3
|
10
|
0.0
|
3.5
|
0.6
|
8.1
|
11
|
2.2
|
2.2
|
3.2
|
6.2
|
12
|
1.7
|
1.0
|
0.9
|
2.6
|
13
|
0.0
|
1.0
|
0.2
|
0.5
|
14
|
1.0
|
1.3
|
1.2
|
1.9
|
15
|
2.2
|
3.8
|
2.9
|
10.0
|
16
|
1.8
|
3.0
|
2.2
|
7.1
|
Table 3 presents the mean and
standard deviation values for each group per period. The mean pain relief scores
are the greatest during the second period (P2) for Group 1 and P4 for Group 2
(i.e., when using Farabloc). These period means differ by only 2 or 3 points on
the VAS (scale of 10) as compared to other period means.
The standard deviation values
(Table 3) are slightly higher in the placebo periods than in the pretreatment or
washout periods, indicating the placebo effect was operating on some subjects.
The intervention (Farabloc) standard deviation values are the largest, as
Farabloc apparently worked on some but not on others.
Pain relief rating scores using
the Visual Analogue Scale by 18 subjects in the Farabloc-Placebo (Group 1)
alteration of treatments and by 16 subjects in the Placebo-Farabloc (Group 2)
alteration of treatments.
Table 3.
The mean and standard
deviation values for the VAS scores for the four periods:
(1) pretreatment, (2) Farabloc-Placebo Group 1, Placebo-Farabloc Group 2,
(3) washout, and (4) alteration of treatment.
|
Group |
Period
|
|
1 Mean (sd)
|
2 Mean (sd)
|
3 Mean (sd)
|
4 Mean (sd)
|
Group 1
|
1.22 (1.08)
|
3.96 (2.75)
|
1.54 (1.04)
|
2.36 (1.28)
|
Group 2
|
1.31 (0.90)
|
2.43 (1.93)
|
1.99 ( 1.30)
|
4.27 (3.12)
|
The results of the repeated
measures analysis of variance in Table 4 indicate the statistical significance
of the group-by-period interactions (p < .001). There is a main effect for
periods, and no main effect for groups; both of which are in keeping with the
pattern of the Farabloc effect.
Table 4.
The result
of the repeated measures analysis of variance comparing
the difference in the VAS mean scores for each period by the two groups. |
Source
|
D.F
|
Sum of Squares
|
F-Value
|
p
|
Group
|
1
|
1.76
|
0.25
|
0.6237
|
Period
|
3
|
106.54
|
16.17
|
0.0000
|
Group x period
|
3
|
50.83
|
7.69
|
0.0001
|
Subjects
|
32
|
222.17
|
¡@
|
¡@
|
Error
|
96
|
211.46
|
¡@
|
¡@
|
TOTAL
|
135
|
593.06
|
Tukey's multiple pairwise
comparison range test (p < .05) showed no difference between groups in the
pretreatment/washout periods (i.e., the means 1.2,1.5,1.3,1.9 in Table 3). The
two placebo means (2.4 and 2.4) are the same and not significantly different
from pretreatment/washout means. The two intervention means (4.0 and 4.3) are
quite similar but significantly greater than the pretreatment/washout means.
Ideally in such a cross-over
design, comparing the intervention with placebo means, the two intervention
means would be significantly different than the placebo means (at least within
the group). In this study, the intervention mean in Group 1 is significantly
greater than Group 1 placebo mean, but is not greater than Group 2 placebo mean.
However, Group 2 intervention mean is significantly greater than the Group 2 and
Group 1 placebo means. It is likely that with a few more subjects in each group,
the results would have come out consistent with the ideal pattern.
In summary, the results
indicate that the subjects reported significantly greater pain relief on the VAS
scale when they were using the Farabloc garment as compared to their
pretreatment, washout or placebo pain relief ratings.
DISCUSSION
The results of this study do
not support the hypothesis that the use of Farabloc would have no statistically
significant effect on the intensity of the phantom limb pain. While only few
subjects in this study obtained complete, or near complete pain relief with
Farabloc, most of them reported their greatest pain relief when using the
garment, as compared to other periods. The differences in pain relief scores
between periods were, on the average, about three points on the Visual Analogue
Scale in favour of Farabloc intervention and statistically significant (p
<.001).
Central to the analysis of the
results is the consideration of the clinical (not statistical) significance of
the findings. It may be argued that even if Farabloc works, a difference of
three VAS points (Table 3), on the average, is not a significant pain relief. Of
our 34 subjects, only nine (26%) reported, five or greater, VAS points on pain
relief with Farabloc as compared to their individual pretreatment or washout
periods.
On the question of clinical
significance, we can only offer the study's findings and the observation that
the material was found to be harmless. It is reusable, obtainable without a
prescription, and inexpensive (about $400.00) as compared to other dubious
therapeutic measures in use. Many individuals will find the garment
uncomfortable to wear in bed, or impractical when at work or in public.
Discomfort with the garment may explain the response of Subject 5 in Group 2 who
reported to be in greater pain with the garments (placebo and Farabloc) than
during the periods without them. In this study, only people with episodic pain
were involved. The manufacturer does not recommend Farabloc if the pain is
constant. Thus, these limitations further restrict the number of potential
users.
At present there is no widely
successful method for treating phantom limb pain. Based on exhaustive literature
reviews, authors (Sherman, Sherman & Gall, 1980; Sherman, Ernst, Barja, & Bruno,
1988) have concluded that the reports of beneficial interventions have been
generally supported by small research samples, flawed research designs,
transient effects, or with below the expected rate of placebo response. Yet,
many treatment methods continue to be used. Some work for some individuals.
Plausible scientific explanations have been offered for a few interventions
based on a variety of theoretical concepts of cause and pathophysiology.
Unfortunately, phantom limb pain remains elusive even with the most diligent
medical management. Experts have recommended that the elements of patient's
complaints (e.g., burning or cramping; pain at night or pain with decreased
atmospheric pressure; or a combination of these) be delineated to help in the
selection of a specific therapy (Iacono, Linford, Sandyk, 1987; Sherman, 1989).
We are unable to explain our results based on any of the current etiologic
theories. We attempted to distinguish the characteristics of those who benefited
from Farabloc from those who did not. They were similar in history, symptoms
experienced, and personal variables.
According to the manufacturer,
phantom limb pain is caused by external electrical and magnetic fields
irritating the severed nerve endings of the stump. The assumption is made that
the human nervous system is analogous to a complex set of electrical receptors
and conductors, with the brain acting as a central receiving station. In this
system, protection from external electrical and magnetic fields is thought to be
normally provided by the surface layers of body tissue, which is lacking over
the scar of an amputation site. Therefore, when the severed nerve endings are
exposed to external electric and magnetic fields, the brain perceives the
irritation as pain. It is reasoned that the Farabloc garment would repel the
external forces and protect the nerve endings through the shielding effect of
its wire mesh.
This study was concluded in
late 1991. Ideally at the end of a subject's participation, we would have
allowed the subject to select one of the two garments (Farabloc or placebo) for
a follow-up after six months or a year. The realities of funding limitations and
the difficulties of maintaining an intact group prevented us from pursuing the
study. A replication of our results is recommended.
REFERENCES
Evans, F. J. (1974) . The
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Huskisson, E. C. (1983). Visual
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York, NY: Raven Press.
lacono, R. P., Linford, J., &
Sandyk, R. (1987). Pain management after lower extremity amputation.
Neurosurgery, 20, 496-500.
Jensen, M. P., Karoly, P., &
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six methods. Pain, 27, 117-126.
Jensen, T. S., Krebs, B.,
Nielsen, J., & Rasmussen, P. (1985). Immediate and long-term phantom limb pain
in amputees: Incidence, clinical characteristics and relationship to
pre-amputation limb-pain. Pain, 18, 267278.
Scott, J., & Huskisson, E. C.
(1979). Accuracy of subjective measurements made with or without previous
scores: An important source of error in serial measurements of subjective
states. Annals of Rheumatic Diseases, 38, 558-559.
Sherman, R. A., Sherman, C. J.
& Gall, N.G. (1980). A Survey of current phantom limb pain treatment in the
United States. Pain, 8, 85-99.
Sherman, R. A. (1989). Stump
and phantom limb pain. Neurologic Clinics, 7, 249-264.
Sherman, R. A., Ernst, J. L.,
Barja, R. H., & Bruno, G. M. (1988). Phantom pain: A lesson in the necessity for
careful clinical research in chronic pain problems. Journal of Rehabilitation
Research, 25:VII-X.
Sherman, R. A. Sherman, C. J.,
& Parker, L. (1984). Chronic phantom and stump pain among American veterans:
Results of a survey. Pain, 18, 83-94.
Wall, R., Novotny-Joseph, P., &
MacNamara, T. E. ( 1985). Does amputation pain influence phantom limb pain in
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Tali Conine, Professor of
Physical Therapy, School of Rehabilitation Medicine, University of British
Columbia, Vancouver, British Columbia V6T 2B5, Canada.
Cecil Hershler is a specialist
in Physical and Rehabilitation Medicine and an electrical engineer. He is in
private practice and is an Adjunct Professor, Clinical Engineering Program,
School of Engineering, University of British Columbia, Vancouver, British
Columbia V6T 2B5, Canada.
Steacy Alexander is a staff
physiotherapist at G.F. Strong Centre, 4255 Laurel Street, Vancouver, British
Columbia V5Z 2G9, Canada.
Robert Crisp is a staff
physiotherapist at the University Hospital - Shaughnessy Site, 4500 Oak Street,
Vancouver, British Columbia V6H 3N1, Canada.
Please direct all
correspondence and reprint requests to Tali Conine at the address above.
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