Authors:
Loren M. Fishman, MD
Craig Konnoth
Bernard Rozner, PhD
Affiliations:
From Columbia College of Physicians
and Surgeons, New York, New York
(LMF); Fordham University New
York, New York (CK); and Deaconess
and Brigham and Womens Hospitals,
Harvard Medical School, Boston,
Massachusetts (BR).
Correspondence:
All correspondence and requests for
reprints should be addressed to Loren
M. Fishman, MD, 3 East 83rd Street,
New York, New York 10028.
0894-9115/04/8301-0042/0
American Journal of Physical
Medicine & Rehabilitation
Copyright 2003 by Lippincott
Williams & Wilkins
DOI: 10.1097/01.PHM.0000104669.86076.30
42
Electrodiagnosis
CME Article 2004 Series Number 1
Botulinum Neurotoxin Type B and
Physical Therapy in the Treatment
of Piriformis Syndrome
A Dose-Finding Study
ABSTRACT
Fishman LM, Konnoth C, Rozner B: Botulinum neurotoxin type B and physical
therapy in the treatment of piriformis syndrome: A dose-finding study. Am J
Phys Med Rehabil 2004;83:4250.
Objective: To measure dosage effects of botulinum neurotoxin type B with
physical therapy in piriformis syndrome.
Design: Prospective study of consecutive patients complaining of buttock
pain and sciatica, measuring serial H-reflex tests in flexion, adduction, and
internal rotation; visual analog scale; and adverse effects at 0, 2, 4, 8, and 12
wks. We used an electrophysiologic criterion for piriformis syndrome: a 1.86-
msec prolongation of the H-reflex with the flexion, adduction, and internal
rotation test. Four piriformis syndrome groups were identified. Serial groups
were injected once with either 5000, 7500, 10,000, or 12,500 units of botu-
linum neurotoxin type B in successive months under electromyographic guid-
ance in four separate locations of the affected piriformis muscle, with a 1-mo
safety observation period between groups. Patients received physical therapy
twice weekly for 3 mos.
Results: The flexion, adduction, and internal rotation test and visual analog
scale declined significantly, correlating at 72% sensitivity and 77% specificity.
A total of 24 of 27 study patients had 50% pain relief. Mean visual analog
scale score declined from 6.7 to 2.3. A volume of 12,500 units of botulinum
neurotoxin type B was superior to 10,000 units at 2 wks postinjection. The
most severe adverse effects were dry mouth and dysphagia, approaching
50% of patients at 2 and 4 wks.
Conclusion: Physical therapy and 12,500 units of botulinum neurotoxin type
B seem to be safe and effective treatment for piriformis syndrome. In addition,
the flexion, adduction, and internal rotation test seems to be an effective means
of diagnosing piriformis syndrome and assessing its clinical improvement.
Injection may benefit patients for 3 mos.
Key Words: Piriformis, Electrodiagnosis, Chemodenervation, Rehabilitation
Am. J. Phys. Med. Rehabil. Vol. 83, No. 1
 Figure 1: The H-reflex elicits the Achilles tendon reflex through electrical stimulation of the sciatic nerve at the popliteal
fossa. Standard EMG equipment measures the latency of this monosynaptic reflex in 105 secs and 106 volts. It is
generally studied in the anatomical position (A). The FAIR test compares the H-reflex obtained in the anatomical position
with H-reflexes obtained in flexion adduction and internal rotation, in which the piriformis muscle is stretched tightly
against the sciatic nerve (B). Prolongation of the H-reflex by 1.86 msecs (3 standard deviations beyond the mean),
indicating significant compression of the nerve by the muscle, is diagnostic of piriformis syndrome (C).

Objectives: On completion of this article,

the reader should be able to (1) state
clinical and electrophysiologic criteria for
I n 1947, Robinson1 began the modern
study of piriformis syndrome (PS) by
putting annual incidence at 4.8 6.4
million cases. Diagnostic methods have
advanced to reliably identify 1,014 pa-
piriformis syndrome, (2) give two clinical
describing six characteristics: (1) trau- tients, 79% of whom recovered 50% or
motives to utilize more than one botuli-
num neurotoxin, and (3) explain the ma; (2) pain in the muscle, with sciat- more with a maximum of 3 mos of
technique for botulinum toxin injection ica and difficulty walking; (3) worsen- conservative therapy for PS.10 That
of the piriformis muscle, with clinical and ing with squatting or lifting; (4) a therapy has evolved to include nerve
electrophysiologic follow-up. sausage-like mass within the muscle; block injection, physical therapy, and a
(5) positive Lasegue sign; and (6) glu- home program.10 The current article
Level: Advanced.
teal atrophy. During the last decade, describes an attempt to refine the in-
Accreditation: The Association of Aca- interest in the detection and treatment jection technique and demonstrates
demic Physiatrists is accredited by the of PS has grown.2 8 Estimates5 suggest improved treatment efficacy. In the
Accreditation Council for Continuing
that PS comprises 6 8% of the 80 mil- course of the study, new aspects of the
Medical Education to sponsor continuing
medical education for physicians. lion cases of low back pain and sciatica diagnostic and treatment methods
seen in the United States each year,9 appeared.
The Association of Academic Physiatrists
designates this continuing medical edu-
cation activity for a maximum of 1.5
credit hours in Category 1 of Physicians
Recognition Award of the American Med-
ical Association. Each physician should
claim only those hours of credit that he
or she actually spent in the education
activity.

Disclosure: Disclosure statements have

been obtained regarding the authors rela-
tionships with financial supporters of this
activity. There is no apparent conflict of
interests related to the context of participa- Figure 2: In piriformis syndrome (PS), the mean H-reflex delay in the FAIR test
tion of the authors of this article. was 3.34 msecs, 5 standard deviations beyond the mean, while normal and
contralateral limbs were clustered near 0.01 msec delay. Reproduced with
permission of the publisher (9).

January 2004 Treatment of Piriformis Syndrome 43

 extra ocular musculature in dyscon-
jugate gaze and cranial nerve dys-
function,11 cervical dystonia,1215
neurogenic bladder,16 back and leg
pain,17,18 countering various forms of
headache,19 reducing spasticity in
multiple sclerosis, and improving
function in cerebral palsy and after
stroke, and use in PS.20 23 More re-
cent research has centered on reduc-
ing idiopathic muscle spasm and
muscle tightness caused by overuse,
trauma, or occupation.15 One recent
study on the piriformis muscle found
type A neurotoxin superior to methyl
prednisone in relieving pain.22,23
Figure 3: EMG injection needle was generally inserted 11.5 inches. It was Currently, the use of botulinum neu-
then adjusted until abduction of the flexed thigh produced a good interference rotoxins in myofascial pain syn-
pattern, indicating that the tip was either in the gluteus maximus or the pirifor- dromes focuses on the myoneural
mis muscle. If extension produced no interference pattern, indicating that it junctions of intrafusal muscle
was not in the gluteus maximus, the injection was made. If interference was fibers.23
seen, another depth was sought. This was done at each of the four sites. It As the number of uses of botuli-
turned out to be a good feedback and self-teaching method. Rarely were more num neurotoxins has grown, the
than two attempts necessary at any site; the first was sufficient 85% of the
number of botulinum neurotoxins in
time.
clinical use has increased.11 This line
of research has several motives.
Botulinum neurotoxins have muscular contraction since the first There is a natural impetus to find the
been successfully used in clinical strabismus patient was injected in most effective agent for a given pur-
practice to reduce the strength of 1977.11 Examples include balancing pose, to find alternative medications
that can be used in the case of en-
countered immunity, and to find one
that can be used to reduce the induc-
tion of immunity in patients receiv-
ing repeated injections. Last, there
are economic motives, which vary
among patients, providers, insurers,
and pharmaceutical firms. Efficacy,
longevity, and adverse effect profile
are crucial to each party for every one
of these issues.
Although dosage guidelines for
several botulinum neurotoxins have
been empirically established for extra
ocular imbalance, blepharospasm,
hemifacial spasm, torticollis, PS, and
other clinical entities,1123 newer appli-
cations lacking clinical confirmation
use extrapolated dosages based on pre-
vious experience. Because pathoge-
netic mechanisms, muscle structure,
Figure 4: The four infection sites may be close to the sciatic nerve and three size, and mechanical advantage vary
sensory nerves without causing difficulties, because botulinum toxins are ac- markedly, it is critical to establish and
tive only at the myoneural junction. IG, inferior gluteal nerve; PF, posterior refine the toxins administration
femoral cutaneous nerve; SGN, superior gluteal nerve. empirically.

44 Fishman Am. J. Phys. Med. Rehabil. Vol. 83, No. 1

 improvement, suggesting that the
TABLE 1 piriformis muscles mechanical en-
Physical therapy protocol for patients diagnosed with trapment of the sciatic nerve was
piriformis syndromea the pathogenetic mechanism and
giving an objective measure that
Place the patient in contralateral decubitus and flexed, adducted, and internally
rotated (FAIR) position.b paralleled subjective reports of im-
(1) Ultrasound, 2.02.5 W/cm2, applied in broad strokes longitudinally along provement. These characteristics
the piriformis muscle, from the conjoint tendon to the lateral edge of the present an excellent opportunity to
greater sciatic foramen, for 1014 mins.b measure the efficacy of botulinum
(2) Wipe off ultrasound gel.c
neurotoxin type B (Bt-B), used with
(3) Apply hot packs or cold spray at the same location for 10 mins.
(4) Stretch the piriformis muscle for 1014 minutes by applying manual the same physical therapy described
pressure to the muscles inferior border, being careful not to press in the study validating the FAIR-
downward, but rather directing pressure tangentially, toward the ipsilateral test study, in the treatment of PS.10
shoulder.d
(5) Perform myofascial release at lumbosacral paraspinal muscles.
(6) Perform McKenzie exercises.
(7) Use lumbosacral corset when treating patient in the FAIR position.e MATERIALS AND METHODS
Duration: two to three times weekly for 13 mos.
a
Patients usually require 23 mos of biweekly therapy for 60 70% improve- Study Population. Serial patients
ment; bbecause it is painful, patients often subtly shift to the prone position. This complaining of buttock pain and sci-
must be avoided because it works to place the affected leg in abduction, not atica received thorough medical his-
adduction, greatly reducing the stretch placed on the piriformis muscle; ccavita- tory, physical examination, and elec-
tion is unreported in 20,000 treatments; dunless explicitly stated, therapists may
tromyographic examination (EMG),
tend to knead or massage the muscle, which is useless or worse. The muscle must
be stretched perpendicular to its fibers, in a plane that is tangent to the buttock including comparison of posterior
at the point of intersection of the piriformis muscle and the sciatic nerve, but tibial and peroneal H-reflexes elicited
approximately 11.5 inches deep to the buttock (i.e., just below the gluteus in flexion adduction and internal ro-
maximus); ethis is particularly important to avoid inducing lumbar hypermobility tation with H-reflexes recorded in the
in patients with histories of laminectomy, fusion, or spondylolisthesis. anatomic position (the FAIR-test).

Criteria for Exclusion and Inclusion.

Outcome studies using prolon-
gation of the H-reflex in flexion,
adduction, and internal rotation
(the FAIR-test) to identify PS and
cortisone/lidocaine injection with
physical therapy to treat it, have
shown an average of 71% improve-
ment on long-term follow-up of
1,014 cases.10 Electrophysiologic
variables closely followed clinical
Patients were excluded from the
study for: (1) previous exposure to
botulinum neurotoxins, (2) electro-
physiologic evidence of paraspinal de-
nervation or denervation of pelvic or

TABLE 2
Mean change in visual analog scale by dosea
2 Wks Mean, 4 Wks Mean, 8 Wks Mean, 12 Wks Mean, Overall Mean,
Dose Group SE, n SE, n SE, n SE, n SE, n
5,000 2.6, 0.28, 8 2.4, 0.78, 8 2.4, 0.75, 8 3.4, 0.89, 8 2.61, 0.59, 8
7,500 2.14, 1.14, 7 2.83, 0.78, 6 3.2, 1.19, 5 1.3, 0.87, 7 2.12, 0.75, 7
10,000 2.5, 0.51, 6 2.56, 0.92, 6 4.16, 1.08, 5 2.62, 1.14, 4 2.89, 0.60, 6
12,500 5.55, 0.55, 5 5.39, 0.86, 5 3.60, 1.62, 5 3.0, 0.74, 4 4.51, 0.30, 5
Comparison P Value P Value P Value P Value P Value
5,000/7,500 0.45 0.71 0.61 0.10 0.55
5,000/10/000 0.73 0.69 0.27 0.54 0.75
5,000/12,500 0.004 0.021 0.44 0.73 0.048
7,500/10,000 0.73 0.98 0.58 0.38 0.39
7,500/12,500 0.004 0.057 0.82 0.27 0.017
10,000/12,500 0.011 0.06 0.74 0.81 0.11
Overall 0.013 0.11 0.70 0.41 0.099
a
Consistent sample displayed largely comparable values, with overall analysis of variance, P 0.028.

January 2004 Treatment of Piriformis Syndrome 45


Figure 5: More than 80% of patients reported dramatic relief. Possible expla-
nations of the rise of pain in week eight include duration of the effect of
medication, nongradual resumption of overuse that initiated symptoms, and
discontinuation of physical therapy against medical advice.
lower limb muscles not innervated by
the sciatic nerve, (3) pregnancy, and
(4) coagulation or vascular abnor-
malities. Inclusion criteria in our
previous study were10: (1) sciatica, (2)
pain on palpation in the region of
intersection of sciatic nerve and piri-
formis muscle, and (3) Lasegue-sign
positivity at 15 degrees less on the
affected than the unaffected side, or
65 degrees in bilateral cases.
However, favorable results in
that study were more strongly corre-
lated with prolongation of the H-re-
flex beyond 1.86 msecs (SD, 3), with
flexion, adduction, and internal rota-
tion of the affected leg(s) (the FAIR-
test) (Figs. 1 and 2). This last crite-
rion was used alone as the inclusion
criterion in this study. Previous in-
vestigations have described a high
percentage of asymptomatic patients
with abnormalities on magnetic res-
onance imaging.24 Imaging studies
were not used to qualify or disqualify
patients in this study.
TABLE 3
Net mean adverse effects
Net Values
Group 2 Wks
5000 1.22
7,500 0.63
10,000 0.32
12,500 0.98
46 Fishman
Study Design. The first eight pa-
tients meeting this criterion, and
giving informed consent to the pro-
tocol approved by the Sound Shore
Medical Center institutional review
board, were injected with 5000
units of Bt-B. Adverse-effects pro-
files were obtained, along with a
10-point visual analog scale of pain
and FAIR-tests, at weeks 0, 2, 4, 8,
and 12. Telephone interviews made
up for missed appointments (13%).
Subsequent cohorts received injec-
tions of 7500 units, 10,000 units,
and 12,500 units of Bt-B. Serial co-
horts were initiated 1 mo after the
previous group, provided no serious
adverse effect was seen in previ-
ously injected patients during the
interim. Each patient was offered
a second injection after 12 wks of
participation in the study at the
dosage that the study determined as
optimal.
4 Wks 8 Wks 12 Wks
0.61 0.15 1.28
0.46 0.63 0.3
1.36 0.41 0.21
1.77 0.42 2.52
Am. J. Phys. Med. Rehabil.
Outcome Measures. This was a dose-
finding study. The outcome sought
was therefore a ratio of benefits to
side effects at particular dosages, with
other factors being held constant.
Perceived benefit was measured by
the 10-point visual analog scale; for
neurophysiologic change in sciatic
compression by the piriformis mus-
cle, successive FAIR-tests were com-
pared. Adverse effects after injection
were recorded as detailed below.
Injection. Bt-B is one of seven neu-
rotoxins produced by the botulinum
bacterium. It is a 150 kDa molecule
consisting of a light chain (50 kDa)
and a heavy chain (100 kDa). The
heavy chain secures binding of the
toxin, which is critical for receptor-
mediated endocytosis (i.e., cell en-
try). The light chain then acts as an
endoprotease to deconstruct vesicle
associated membrane protein (synap-
tobrevin), essential for the extrusion
of neurotransmitter packets from the
neuron.2223
Because botulinum neurotox-
ins have a common amino acid se-
quence through 40 50% of their
long chains, there is immunologic
cross-reactivity between, for exam-
ple, type A and type B. However,
there is strong evidence that there
is not cross-neutralization among
these two types of botulinum neu-
rotoxin overall, despite their chem-
ical similarities.2527 Immunologic
distinctness is actually the way the
different neurotoxins were defined.
Four separate injections of equal
size were made into the substance of
the piriformis muscle under EMG
guidance. The patient was positioned
in contralateral decubitus, with hips
and knees flexed to 90 degrees. A 3.5-
inch, no. 23 EMG injectable needle
was inserted three-fourths of an inch
into the buttock 2 inches medial to
the greater trochanter and slowly ad-
vanced until a fair or good interfer-
ence pattern was seen on abduction
of the flexed thigh. This was taken to
indicate that the needles tip was ei-
Vol. 83, No. 1
 therapists who were geographically
TABLE 4 prevented from access to our facili-
Relationship between Myobloc dosage and presence of side- ties. All of these patients had one
effects session with our therapists, and the
Test for Trend
similar content and quality of therapy
thereafter was reported in periodic
High Dose, Low Dose,
Side Effect Dose Standard Error P Value 12,500 Units 5,000 Units
telephone interviews described be-
low. The physical therapeutic proto-
Adverse
Asthenia 0.397 0.184 0.030 0.398 0.016 col was also displayed on the Web site
Dry mouth 0.413 0.184 0.024 3.29 0.042 www.sciatica.org.
Myasthenia 0.400 0.189 0.034 4.37 0.009
Beneficiala Adverse Effects. The standard
Buttock pain 0.462 0.213 0.030 0.29 0.043 method for measuring adverse effects
Headache 0.464 0.195 0.006 0.12 0.010 involves asking patients, Did you ex-
Rhinitis 0.369 0.193 0.055 0.18 0.034
perience any symptoms after admin-
Dyspepsia 0.399 0.200 0.046 0.34 0.14
a
istration of the medication? and
These side-effects are negatively correlated with dose. This may be used in
records and tabulates responses. In
the clinical context, for example, to decrease the dyspepsia caused by previous
nonsteroidal use that the injection also makes unnecessary. this study, results of that type of in-
terrogation from previous studies
were used in presenting to patients a
list of all common adverse effects
ther in the gluteus maximus or the was seen on abduction, then the nee- seen after Bt-B injections thus far
piriformis muscle. Then, the patient dle was retracted until an interfer- published in torticollis/cervical dys-
was asked to squeeze his or her ence pattern was seen. Then, the nee- tonia cases. When present, adverse
thighs together and extend the dle was slowly advanced as before, effects were estimated as mild, mod-
thighs. If an interference pattern was avoiding possible misidentification of erate, or severe. Patients were then
seen, then the needle was advanced the gemellus superior as the pirifor- asked, Did you experience any other
until thigh extension did not pro- mis muscle. Infection followed this symptoms after administration of the
duce any interference pattern. This procedure at each of the injection medication? and each new symptom
suggested that the needle tip had left sites (Figs. 3 and 4). Each patient was quantified according to the same
the gluteus maximus muscle and then received physical therapy twice tripartite scale.
was located in the piriformis muscle weekly for 12 wks from one of three To measure intensity and, in a
just beneath it. therapists who knew the protocol sense, the importance of any symp-
If, after initial introduction of well (Table 1). The protocol was tom, two further methods were help-
the needle, no interference pattern printed out and sent to patients and ful. First, each patient was given a
shorter version of the visual analog
scale in which symptoms were rated,
and the rating was assigned a num-
ber: mild 1, moderate 2, and
severe 3. The total score for each
symptom was divided by the number
of patients reporting to obtain the
mean severity by this cardinal scale.
Second, the symptoms initial
mean severity, the mean for the en-
tire cohort receiving a given dose,
was recorded before they received
any medication and was subtracted
Figure 6: H-reflex latency prolongation followed the clinical course depicted in
from their mean severity for that
Figure 5. The parallel reduction of patient discomfort and values of the FAIR
symptom for subsequent weeks.
test allows independent confirmation of the treatments efficacy and the validity
of the pathogenetic mechanism. Adverse effect (AE) profile is commensurate This was done to estimate how ad-
in timing the infections influence. This gives an independent and objective ministration of the medication in-
measure of medication and treatment efficacy, helping to validate an open label creased or decreased overall experi-
study. VAS, visual analog scale. ence of that particular complaint.

January 2004 Treatment of Piriformis Syndrome 47

 (2 17.02, P 0.0001) (Tables 5
TABLE 5 and 6, Fig. 7). This relationship yields
Clinical and electrophysiologic response to botulinum independent verification of the effi-
toxin type b by dose over time cacy of treatment consisting of Bt-B
injection and physical therapy (Fig.
Week
7). Unusual adverse effects, including
0 2 4 8 12
monocular blurry vision, severe
Visual Analog Scale
heartburn (two cases), severe consti-
5000 5.47 3.31 3.06 3.06 2
7500 7.36 5.214 4.33 4.63 6 pation (one case), and difficulty swal-
10,000 5.6 2.88 2.52 1.44 1.67 lowing (two cases), were seen only at
12,500 7.2 1.65 1.81 3 2.5 the dose of 12,500 units and were
Mean 6.4075 3.2635 2.93 3.0325 3.0425 limited to 4 6 wks in all cases. No
FAIR test (PT) adverse effect required medical
5000 2.98 0.6 1.97 1.19 1.87
7500 2.99 0.6 0.83 4.09 0.55
attention.
10,000 2.52 0.98 1.77 1.87 0.08 Seven patients requested reinjec-
12,500 3.11 0.87 0.5 0.44 3.34 tionthree on the same side, four
Mean 2.9 0.4625 1.0175 1.8975 1.46 contralaterally. Although the sample
FAIR test (Per) size was extremely small, three
5000 1.66 0.3 0.61 0.4 0.2
trends were noted: (1) improvement
7500 1.92 0.24 1.13 1 0.8
10,000 1.25 0.09 0.68 0.605 1.5 was generally as great or greater than
12,500 2.37 0.55 2.3 0.6 2.08 after the first injection, and (2) ad-
Mean 1.8 0.145 0.03 0.1513 0.645 verse effects were reduced in number,
FAIR, flexion, adduction, and internal rotation; PT, posterior tibial nerve; intensity, and duration, regardless of
Per, peroneal nerve. the dose initially injected. Mean dry
mouth, asthenia, dysphagia, and a
strange taste in the mouth were ex-
perienced below the mean levels seen
In some cases, this number, the net before joining the study. Two patients at first injection, despite the fact that
adverse effect, was negative. left the study, each because magnetic the second dose was higher than that
resonance imaging ordered in our of- given initially in six of seven reinjec-
fices turned up large herniated lum- tions, regardless of whether the sec-
RESULTS ond injection was ipsilateral or con-
bar intervertebral discs for which
Patients averaged 53 yrs of age, they had surgical procedures. Both tralateral to the first. Finally, (3)
with a mean 6.2 yrs of sciatica, and EMG guidance of ipsilateral reinjec-
were replaced by waiting-list patients.
had seen an average of 5.8 clinicians tion detected positive sharp waves
Clinical improvement by visual
and fibrillation potentials in the piri-
analog scale was greatest at 12,500
formis muscle in two of three cases.
units of Bt-B (overall analysis of vari-
None had been seen with the initial
TABLE 6 ance, P 0.013) (Table 2, Fig. 5). All
injections.
groups had their most dramatic im-
Relationship between Injection of Bt-B followed by
provement between weeks 2 and 5,
visual analog scale and physical therapy significantly short-
when adverse effects were most evi-
posterior tibial FAIR test ened recovery time, thereby reducing
dent as well. The most frequent ad- both patients pain and treatment
Visual Analog Average Fair- verse effects were dry mouth and dys-
Scale Test time. Previous studies confirm a 71%
phagia, which showed a dose-related average improvement using a some-
1.86 1.86 Total
response curve (Tables 3 and 4, Fig. what different injection technique
5 26 10 36
6). Severity of all adverse effects in with lidocaine and steroid and iden-
5 10 33 43
Total 36 43 79 weeks 2 and 4 generally increased tical physical therapy.10 Other work
with dosage. had a 60% improvement rate inject-
FAIR, flexed, adducted, and
internally rotated. FAIR-test values closely paral- ing botulinum neurotoxin type A dif-
Sensitivity 72%, specific- leled clinical improvement. Correla- ferently, but using identical physical
ity 77%, 2 17.02, df 1, P tion of the posterior tibial FAIR-test therapy.26 Injection of 12,500 units
0.0001. and visual analog scale had a sensi- followed by the standard physical
tivity of 72% and specificity of 77% therapy reduced pain 50% in 88.9%

48 Fishman Am. J. Phys. Med. Rehabil. Vol. 83, No. 1

 encountered in the piriformis mus-
cles of two of three ipsilaterally rein-
jected individuals. None were noted
during the EMG-guided initial injec-
tion procedures. One possibility is
that the temporary presynaptic dis-
ruption of myoneural junctions
brought about by Bt-B may cause
longer-term denervation. The im-
Figure 7: A list of the common adverse-effects seen previously was presented proved response in the three patients
at each patient encounter. Note that patients were asked specifically about who were reinjected ipsilaterally at
each of these, hence the large number of positives reported. Write-ins in- these two doses may result from this.
creased notably at 12,500 units, including monocular blurred vision (one case), All adverse effects noted in this
gastroesophageal reflux (two cases), and lump in throat (two cases). 1, dry study relate to extrapelvic locations,
mouth; 2, dysphasia; 3, dyspepsia; 4, strange taste in mouth; 5, nausea; 6, probably because of the small quan-
headache. tity of toxin that inevitably enters the
systemic circulation. The reduced ad-
verse-effect profile seen in reinjected
of patients within 2 4 wks, seem- injections. Although averaging 3 mos patients, despite an increased dose of
ingly more effective than any previ- of twice-weekly sessions, 60% of toxin, leaves one to speculate about
ously published results. The fact that patients sustained at least a 50% im- an immunologic response to the ini-
just three of 27 subjects requested provement.29 It is possible that Bt-B tial inoculation with Bt-B, which
ipsilateral reinjection after 3 mos injection induces a definite degree of neutralized traces of the biological
suggests greater longevity to the ef- relaxation in the piriformis muscle that appeared systemically. These two
fects of Bt-B injection in PS than for a roughly uniform stretch of time considerations may be significant fac-
would be seen from the effects of the but that physical therapy takes the tors in its repeated use, including its
toxin alone. All seven reinjected pa- muscle and the patient the rest of the possible use in alternation with other
tients responded with 50% im- way back to painlessness. Porta22 types of botulinum neurotoxins,
provement at 2, 4, 8, and 12 wks. found that botulinum neurotoxin which are immunologically distinct
type A injections were more effective by definition.
than vehicle alone at 2 mos after The technique presented here
DISCUSSION injection. would be improved by knowing
Although there is disagree- The mechanism by which 24 of where the greatest concentrations of
ment,28 overuse seems to be the most 27 patients benefiting from Bt-B in- myoneural junctions are found in the
common cause of PS.10 This may be jections sustained their improve- piriformis muscle. The study lacks
relevant to the temporary increase of ment, despite an average of 6 yrs of adequate explanation of why subse-
symptoms that was seen between suffering and the relatively short pe- quent injections are both more effec-
weeks 4 and 8. There is mention in riod of botulinum neurotoxin activity tive and accompanied by fewer and
five patients records of overuse abuse (8 16 wks) is unknown. One possi- less severe adverse effects. Further
within a few weeks of the dramatic bility is that once the piriformis mus- histologic work is clearly needed
improvements they experienced after cle is stretched, its normal function here; if prolonged denervation is
their injections. This may account for becomes incorporated into daily ac- widespread, it would explain why pa-
the temporary reversal in their recov- tivities such as walking and rising tients requiring serial injections fre-
ery (Fig. 5). It suggests that patients from the sitting position and thus quently do so at expanding intervals
must be effectively cautioned about retains its greater, noncompressive and, in some cases, eventually do not
plunging back into the type of activ- length and tone. This would be anal- require them at all. If immunologic
ity that brought about the PS in the ogous to the way adhesive capsulitis, activity is modulating systemic ad-
first place. once resolved, recurs infrequently. verse effects, it will be important to
However, the overuse itself One previously undiscussed as- understand how to regulate it.
seems to succumb to continued phys- pect of botulinum type B injection
ical therapy. This later recovery curve appeared during this study. Inadver-
SUMMARY
is shown in Figure 5. Some previous tently, using EMG guidance while re-
treatments of PS consisted solely of injecting patients, positive sharp The results of our study suggest
physical therapy and did not include waves and fibrillation potentials were that Bt-B relieves pain attributed to

January 2004 Treatment of Piriformis Syndrome 49

PS in a dose-dependent manner. In-
jection of 12,500 units of Bt-B had
slightly greater adverse effects but
significantly greater clinical and elec-
trophysiologic measures of improve-
ment. Injection of Bt-B relieved pain
more quickly and more effectively
than lidocaine and steroid or botuli-
num neurotoxin type A injections in
previous reports.29,30 In addition, the
study suggests that the pathogenetic
mechanism of PS is muscular com-
pression of the sciatic nerve, indi-
cated by the parallel reduction of
symptoms and of delay seen in the
FAIR-test. This objective variable
might facilitate further research into
effective remedies of PS.
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