1. health and fitness
2. therapy

Critical Reviews™ in Physical and Rehabilitation Medicine, 17(1):000–000 (2005)
Fibromyalgia/Chronic Pain Syndrome:
An Alternative Medicine Perspective
Gordon D. Ko, MD, CCFP(EM), FRCPC,1,2 Scott Whitmore, BSc(PT),2
Bob Gottfried, PhD,2 Annie Hum, MD, CAFCI,2 Michael Rahman, ND,3
George Traitses, DC,2 Sylvia Loong, BSc(PT),2 Karen Steward, RNCP,2
David Berbrayer, MD, MCFP, FRCPC,1 & Michael Jokic, BSc(Hon)1
1Fibromyalgia Treatment Clinic, Department of Rehabilitation Medicine, Sunnybrook & Women’s
College Health Sciences Centre, University of Toronto, Toronto, Canada; 2Canadian Centre
for Integrative Medicine, Markham, Ontario, Canada; 3Pinewood Natural Health Centre,
Toronto, Canada
*
Address all correspondence to Dr. Gordon Ko, 12 Main Street North, Markham, Ontario L3P 1X2; E-mail through the
webmaster at www.musclepainrelief.ca. The authors received no support for this review.
ABSTRACT: Purposes: To review the current literature on pain management in fibromyalgia (FMS) including
complementary alternative medicine (CAM) use and to report on treatment and rehabilitation strategies. Methods:
A literature review of MEDLINE and EMBASE for published randomized controlled trials for FMS pain
treatment was carried out. This was critiqued with the Jadad criteria for quality trials in the chronic pain population.
Clinical experience in treating and following such patients over the last 20 years is discussed. Results: Most published
studies are of low quality. We report case studies of patients who significantly improved with specific CAM
therapies, indicating the need for future research in these areas. Conclusion: Studies suggest that FMS patients may
be effectively managed for pain with Botulinum toxin A injections with an integrative rehabilitation approach. This
needs to be confirmed with large randomized controlled trials.
KEY WORDS: fibromyalgia, chronic pain syndrome, myofascial trigger point, low back pain, migraine, botulinum toxin A, prolotherapy, neurotherapy, naturopathy, alternative medicine
I. INTRODUCTION
“Complementary and Alternative Medicine” refers to treatments that are “generally not used or
recommended within the context of mainstream
biomedical community.”1 Over the last few decades, there has been an ever-growing demand
for Complementary and Alternative Medicine
(“CAM”). A recent report released by the National
Center for Complementary and Alternative Medicine (National Institute of Health) found that
62% of 31,044 adults interviewed had used some
form of CAM therapy in the year 2002.2 A random telephone survey of 2055 adults by Eisenberg
et al3 revealed that 42.1% of adults in 1997 had
used CAM during the previous year. This is an
0896-2960/05/$35.00
© 2005 by Begell House, Inc.
increase from 33.8% of adults in an earlier 1990
study.4 Estimated expenditures for such services
reveal a 45.2% increase to $21.2 billion in 1997.
The total out-of-pocket expenditures for CAM,
including costs of herbal therapies, megavitamins,
diet products, and CAM literature and equipment
was conservatively estimated to be $27.0 billion.
In the physiatric-managed population, a survey of 401 working-age individuals with physical
disabilities revealed that 57.1% used at least one
CAM in the last year.5 A lower percentage of
29.1% of rehabilitation outpatients reported such
usage during the last year.6
Another survey of 1035 adults in the United
States noted 40% used CAM and identified predictors of CAM use as being greater education,
1
poorer health status, an holistic orientation to
health, and cultural factors. Dissatisfaction with
conventional medicine was not predictive of CAM
use.7 Similar findings were noted in a study of
1081 elderly Canadians, with 41.2% (of those
without cognitive loss) using CAM.8
From these surveys (Astin, Barnes, Eisenberg),2,3,7
it was concluded that women were more likely
than men to use CAM. When prayer specifically
for health reasons is excluded from the definition
of CAM, the highest use was noted in the middleaged (baby boomers). The highest CAM use was
by patients with musculoskeletal problems and
arthritis. The highest condition-specific rates
were for neck (57.0%) and back (47.6%) problems.
These are conditions commonly seen in physiatric practice.
One group usually seen with neck and back
pain (and, predominantly, middle-aged female)
are the fibromyalgia patients.
II. FIBROMYALGIA OVERVIEW
By the American College of Rheumatology (ACR)
definition, fibromyalgia is a syndrome of widespread muscle pain (over 3 months) and stiffness,
with 11 or more characteristic tender points on
palpation.9 It affects 2% of the population, predominantly females, with the most common age
at presentation of 40 to 50 years.10 Symptoms in
the fibromyalgia syndrome (FMS) include (1)
musculoskeletal complaints: “hurt all over,” stiffness, swollen feeling in tissues; (2) nonmusculoskeletal: fatigue, poor sleep, paresthesia; and (3)
associated syndromes such as irritable bowel (IBS)
(41.8% of FMS patients),11 dysmenorrhea,12 female urethral syndrome,13 endometriosis,14 noncardiac chest pain,15 plantar heel pain,16 migraine
headache (45%),17 temporomandibular joint pain,18
sinusitis,19 and Sjogren’s syndrome.20 A higher
incidence of carpal tunnel syndrome (14.1%)21
and Raynaud’s syndrome (38%)22 may explain
some of the paresthesia complaints.
Higher anxiety and depression have also been
reported.23 24 Postulated risk factors for the development of FMS include a family history of this
condition,25 a family history of depression and/or
alcoholism in first degree relatives,26 childhood
physical and sexual abuse, eating disorders and
2
drug abuse,27,28 and hypermobile joint syndrome.29
FMS has also been documented after physical
trauma30,31 and whiplash,32 but the causal relationship has not been established in a consensus
report on FMS and disability.33 Physical trauma
perception is associated with greater disability
compensation, and emotional trauma is related to
greater functional disability ratings and a higher
number of physician visits.34 A review on psychosocial aspects concluded that the view that FMS
is caused by stress or abuse is unproven and that
there is no evidence that communicating such a
diagnosis causes iatrogenic consequences.35
It has been postulated that viral infections may
play an etiologic role.36 Seventy percent of FMS
patients meet the Centers for Disease Control and
Prevention criteria for chronic fatigue syndrome
(CFS),37 and 70% of CFS patients meet the ACR
criteria for FMS.38 The usual routine laboratory
tests, such as basic hematology, ESR, muscle enzymes, rheumatoid factor, and ANA, are all normal.39 CFS researchers suggest that deregulation of
the 2.5A synthetase Rnase L antiviral pathway may
be the pathophysiological reason.40
Muscle biopsy41 and MRI spectroscopy 42 studies have proven to be nondiagnostic. More recent
electron microscopy suggests ultrastructural changes
including increased DNA fragmentation (possibly
due to persistent focal muscle contractions).43 Sleep
study findings are abnormal44 but also are not
necessarily specific or unique to FMS.45–47 Reduced growth hormone secretion48 and elevated
CSF substance P,49 homocysteine,50 and nerve
growth factor levels,51 as well as abnormal neuroendocrine challenge tests,52–54 suggest a central
pain mechanism, but no reliable diagnostic test
has yet to be established. More recent research
demonstrates abnormalities on functional MRI
imaging studies55–58 and MRI spectroscopy of
paravertebral muscles.59
The economic impact of this syndrome is
significant. Chronic musculoskeletal pain is the #1
cause of disability in North America, the #2 cause
for visits to the primary care physician and the #3
cause for hospitalizations, with over 250,000 spinal fusions carried out in the United States. It is
estimated that the direct medical cost of FMS to
the U.S. economy is in excess of $16 billion
annually.60 The net cost in Canada in 1993 was
estimated to exceed $700 million.61 Despite such
Critical Reviews™ in Physical & Rehabilitation Medicine
costs, effective long-term treatment remains elusive. The most studied medications to date are the
tricyclic derivatives, such as amitriptyline and
cyclobenzaprine. Randomized trials (RCT) of these
and other treatments as outlined in Table 1 below
only show short-term improvement in symptoms.
Only the most recent or most comprehensive
RCTs are referenced.
FMS patients are high consumers of nonphysician and alternative medical interventions.
One study comparing those using such services
found no differences in level of pain and functional
impairment.62 Another study of 111 FMS subjects
found that 98% had used at least one complementary medical strategy in the preceding 6 months and
that such use was correlated with lower age, higher
pain, and higher disability.63 Use of complementary
therapies was seen in patients of a higher socioeconomic status and a longer duration of fibromyalgia.
The most popular therapy was oral supplementation and the most popular source of advice was from
magazines (40%).64
In September, 2003, Researchers at The University of Toronto conducted a survey65 of CAM
in a community education session attended by 72
FMS participants and found the following:
Most common products tried:
1.
2.
3.
4.
5.
6.
7.
Topical rubs–66.7%
Sleeping pills–66.7%
TENS unit–66.7%
Braces, orthotics–58.3%
Diets–54.2%
Over-the-counter oral medications–54.2%
Glucosamine, herbals, megavitamins–50%
Magnets were tried by 37.5%, and opioids were
used by 41.7%.
Most common CAM therapist/practitioner seen:
1.
2.
3.
4.
5.
6.
Massage–75%
Meditation/relaxation–70.8%
Acupuncture–70.8%
Chiropractic–58.3%
Homeopathy/naturopathy–41.7%
Spiritual healing/prayer–37.5%
TABLE 1
Medications Effective for Pain in FMS
Amitriptyline (10–50 mg effective for first 2 months, but not significant compared to placebo at 6 months).200
Effects may be augmented with the addition of Fluoxetine.201
Cyclobenzaprine (10 mg qhs as effective as 10 mg tid but with less side effects).202
Combined with ibuprofen is helpful for morning stiffness203
Dothiepin (tricyclic similar to amitriptyline).204
Human growth hormone205 (9-month study of 50 FMS females with low IGF-1 levels)
Ketamine206 (0.3 mg/kg i.v. drip in prescreened responders)
Lignocaine207 i.v. drip
Milnacipran (norepinephrine serotonin reuptake inhibitor)208
Odansetron (a 5-Hydroxytryptamine type 3 receptor antagonist)209
Paroxetine210; Venlafaxine (uncontrolled study)210a
SER282 (antidiencephalon immune serum)211
Sodium Oxybate (commercial form of gammahydroxybutyrate)212
Somadril (carisoprodol, paracetamol, caffeine)213
Tizanidine (Zanaflex)214
Topical camphor, methyl salicylate, menthol lotion (uncontrolled study for a duration of 20 minutes)215
Topical capsaicin (35% of neck pain group with FMS )216
Tramadol (i.v. drip, single-dose treatment; 12 patients with 20.6% reduction in VAS pain)217
Tropisetron (5-HT3 receptor antagonist)218
Tryptophan (5 hydroxytryptophan 100 mg tid )219,220
Note: One recent review on pharmacological therapies concluded that the best supported medications to date are
the low-dose tricyclic antidepressants, but that the benefits are short-term and have not been shown to be
superior to placebo at 6 months of study.221,222
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TABLE 2
Medications: Published Trials Found To Be
Not Effective for FMS Pain
Acetaminophen (paracetamol)74
Calcitonin223
Chlormezanone224
Chlorpromazine225
Imipramine226
Lidocaine (4% injected as sphenopalatine
nerve block)227
Lidocaine (i.v. 5 mg/kg), morphine (i.v. 0.3mg/kg)228
Moclobemide229
NSAIDs: Ibuprofen230 (Ibuprofen + alprazolam
did reduce tender-point index (TPI) but not
dolorimetry)231
Naproxen 500 mg bid232
Tenoxicam + bromazepan233
Prednisone 15 mg per day (most variables
deteriorated)234
Ritanserin (a 5-HT2 receptor blocker)235
SSRIs: Citalopram236
Fluoxetine (was helpful for sleep and depression but
not pain at 6 weeks)237
Zolpidem238
Zopiclone239
The next most used therapies were craniosacral therapy, osteopathy, reflexology, hypnosis.
These findings were similar to the general population survey by Eisenberg that rated the 5 most
common CAM: relaxation, herbals, massage,
chiropractic and spiritual healing.3
Further clinical trials are reported in Tables
3A–3D.
In our survey of 116 physiatrists (rehabilitation medicine specialists) in Ontario, Canada,
55% of respondents agreed that FMS is a “real
disabling condition.” When asked what type of
alternative therapy works, 14 different types were
mentioned, with the top three being acupuncture,
biofeedback, and chiropractic.119
TABLE 3A
Physical Therapies Helpful for FMS Pain
Aerobic exercise66–69 (when combined with
flexibility and strength training is superior to
relaxation70)
Pool exercise71,72
Hydrotherapy73–75
Low-power laser therapy76,77
Strengthening exercise78,79
TENS (uncontrolled study)80
4
TABLE 3B
Physical Therapies Not Reported Helpful
Laser81
Shape-of-sleep pillow82
Visible electromagnetic fields83
Note: Exposure to cold tends to aggravate pain in
FMS.84,85 One published RCT study found clinical effectiveness of ceramic-impregnated garments86 for Raynaud’s (which is experienced by
1/3 of FMS patients). A similar study has recently been completed for FMS patients.
TABLE 3C
Psychological Therapies
Cognitive–behavioral therapy87,88
Group therapy,89 including relaxation and cognitive–
behavioral training90
Hypnotherapy91
Meditation-based stress reduction program92
In contrast, a survey104 of FMS patients reported different levels of effectiveness. They rated
the CAM therapy effectiveness on a 5-point Likerttype scale:
–2 markedly worse
–1 mildly worse
0 no change
+1 mildly better
+2 markedly better
Most effective CAM treatment used by at
least 20% of surveyees (avg. score from Likert-type
scale ratings):
1.
2.
3.
4.
5.
6.
Botulinum toxin A (Botox) injections (1.6)
Osteopathy/craniosacral therapy (1.4)
Massage (1.3)
Spiritual healing/intercessory prayer (1.3)
Meditation/relaxation (1.2)
Reflexology, herbals (1.1)
In contrast, medications were rated lower: overthe-counter drugs (0.5), topical rubs (0.7), sleeping
pills (0.9), opioids (0.9). Common CAM therapies
rated lower included acupuncture (0.5), chiropractic
(0.3), glucosamine (0.25), and magnets (0.1).
Critical Reviews™ in Physical & Rehabilitation Medicine
TABLE 3D
Alternative Medicine Treatments with Positive Clinical Trials
Biochemical
DHEA supplementation93
Dietary indole supplementation (ascorbigen and broccoli powder)94
Dietary supplementation of coenzyme Q10, combined with Ginkgo biloba extract95
Homeopathy96,97
Multimodality approach, including nutrition and hormone replacement98
SAMe i.v.99 p.o. (improved VAS pain, not TPI, during last week of 6-week study)100
Super Malic (malic acid 200 mg and magnesium 50 mg: 6 tablets bid )101
Topical 024 essential oils101a
Vegan diet102
Electromagnetic (autonomic nervous system)
Acupuncture 103–105
Copper wire bedsheet106
Cranial electrotherapy stimulation107
Static electromagnetic fields108
Thermoflow ceramic-impregnated garments108a
Psychoemotional
Biofeedback–relaxation (combined with exercise, best across 2 years)109
Biofeedback–EMG110–113 EEG-driven114
Mind–body therapies115
Structural
Chiropractic therapy (4 weeks of spinal manipulation, soft tissue therapy, passive stretching)116
Osteopathy117
Prolotherapy (75% pain improvement; unblinded study)118
One proposed theory for such therapies relieving pain is by resolving muscle “trigger points”
(TrP). It is important to distinguish trigger points
from FMS “tender points” (TeP). The criteria for
TrP are listed in Table 4.
III. OVERVIEW OF BOTULINUM TOXIN-A
FOR PAIN
It has been reported that 72% of FMS patients
have myofascial TrPs.121 Tender points do not
usually respond to injections of local anesthetic,
but trigger points in FMS do.122 Current theories
as to the pathophysiology of myofascial TrP include the dysfunctional motor endplate where
excessive acetylcholine is released.123 Botox is effective for muscle pain/spasticity through its prolonged blockade of acetylcholine.The active moiety, a 150-kDa protein, is the most potent of 7
neurotoxins produced by the Gram positive anaerobic rod-shaped bacteria Clostridium botulinum.124
When injected into muscle, Botox is taken up at
Volume 17 Issue 1
the endplate. Its heavy chain attaches it to the
presynaptic membrane. After endocytosis, the
disulphide bond is broken, allowing the light
chain to move to the presynaptic terminal. There
TABLE 4
Trigger Points and Myofascial Pain
Syndrome Criteria
Major criteria
Pain localized to region, usually unilateral, asymmetric tenderness
Taut band is palpable
Pain in known referred zone
Exquisite spot tenderness
Restricted range of motion due to tight muscle
Minor criteria
Reproduction of pain/altered sensation by pressure
on TrP
Local twitch response on snapping the taut band
Pain alleviated by stretching muscle or by injecting
TrP
Diagnosis requires all the major criteria and at least
one minor criteria.120
5
it binds to 25-kDa synaptosome-associated protein
(SNAP-25), which inhibits the calcium-activated
release of acetylcholine. The onset of muscle relaxation occurs around 3 days, with a peak effect
around 3 to 4 weeks and an average duration of 3
months. A unit of Botox is defined as the LD50 for
a 20-gm Swiss-Webster mouse. (Extrapolated to
the 70-kg human, the lethal dose would be about
2700 units). The recommended maximum dose at
one treatment is 400 units. Doses are spaced out
over 3 months to minimize the risk of developing
antibodies that would prevent Botox from working.
Reported side effects include flu-like illness (rare),
which may last a few days to weeks. Muscle soreness
and stiffness may last 1 to 2 weeks. Inadvertent
weakness depends on the injection site/dose (eg,
eyelid ptosis, swallowing difficulty) and usually lasts
2 to 3 weeks. Endplate targeted injections (with
EMG guidance) appear to be more effective than
anatomical approaches.125 Botox should be stored
in the freezer or refrigerator and reconstituted with
preservative-free normal saline. It loses potency
(35%) when stored (in saline) after 1 week and 44%
after 2 weeks.126
•
•
•
•
•
Initial procaine injections were into muscle trigger points: trapezii, scalene anticus, right T11
erector spinae, right piriformis. Postinjection pain
diary recorded short-term improvement.
Botox injections (03-04/00): 200 units spread
out over: R piriformis (3½″ 22-gauge needle), R
erector spinae, both upper trapezii. Injections done
with EMG guidance.
Postinjection (30-05/00): Improved with 5/18
TeP (1+ 2–4 kg) VAS: 4/10, FIQ: 11.3/90,
OSW: 1/50, SFMcGill: 2/45.
•
•
A. Typical Examples of Treatment
Procedures Using Botox
•
Patient Profile #1
A 33-year-old married, disabled customer service
worker had widespread pain and right sciatica for
5 years. Chronic pain risk factors included childhood sexual abuse, major depressive disorder, panic
disorder, agoraphobia; abnormal sleep EEG (restless legs, alpha-delta intrusion); slip and fall trauma
(Oct., 1988); and car accident (Jan., 1998) (with
a 2-week hospitalization), subsequent home care,
and wheelchair use.
Previous treatments included physiotherapy,
chiropractic, massage, laser, Chan-Gunn acupuncture, hydrotherapy, podiatry orthotics, psychotherapy. Medications included oxycontin, cyclobenzaprine, relafen, gabapentin, rivotril, stadol,
imovane. No response to epidural corticosteroids
(CT scan: L5S1 bulging disc, but EMG study was
normal) or facet joint injections/nerve blocks.
Preinjection findings: (15-03/00) 5′10″ 320 lbs—
obese
6
18/18 TeP (3+), with Fischer algometry scores
all <2 kg
Visual analogue scale (VAS) for pain: 10/10
Fibromyalgia impact questionnaire (FIQ):
69.4/90
Revised Oswestry (OSW): 23/50
Short-form McGill pain questionnaire
(SFMcGill): 37/45
She reported for the first time in years that she
was able to walk several blocks, make beds
without help, do laundry, dishes, and most
yard work. She joined weight-watchers.
(08/00): After 2nd series Botox (400 units),
she weaned off oxycontin and NSAIDs completely.
(11/00): After 3rd series, Botox (400 units),
she had lost 34 lbs. and began vocational
retraining.
Further injections were carried out in 04/01
(300 units), 10/01 (250 units), 02/02 (200 units).
She improved to the point where she could exercise regularly, lose weight (down to 258 lbs), and
work part-time. After 2 years, she returned in Feb
2004 and had 200 units of Botox administered to
recurrent trigger points in the left levator scapulae
and pectoralis minor muscles, right gluteal area.
She returned on March 28, 2005, to have more
Botox injections, which she continued to rate as
extremely helpful.
Patient Profile #2
A 47-year-old female store owner was diagnosed
with migraines, FMS, and CFS after fumigation
gas exposure (1989). Past history: hypothyroidism,
Critical Reviews™ in Physical & Rehabilitation Medicine
childhood growing pains, and tailbone fracture.
Previous treatments included numerous medical
specialists. Normal MRI and SPECT scans of
head. Treated with amitriptyline, NSAIDs, SSRIs,
and tryptophan. No headache relief with imitrex,
sandomigran, opioids. Tried hydrotherapy, psychotherapy, and alternative medicines (dental amalgam removal, intravenous heavy metals chelation,
“neural therapy injections”).
•
•
(09/00): better appetite and weight: 119 lbs.
VAS: 4/10. SFMcGill: 13/45. PDI: 18/70.
18/18 2+ TeP.
Botox injections (12/00): 25 units for headache
+ supraorbital nerve blocks. 75 units: upper trapezii
+ splenii cervicis
Postinjection (01/01): Described “an excellent
response.” Headaches resolved.
Preinjection findings (01/00): 5’8" 145 lbs. BP
100/70 mmHg. Wore dark sunglasses.
•
•
Returned in March for 300 units and has
subsequently had 8 more Botox injections (enabling her to continue fulltime work).
•
Severe (3x/month) left-sided classical migraines
and constant daily tension headaches.
VAS for headache: 7.5/10; FIQ:70.7/90; 18/18
TeP (2-3+).
Botox injections (09/00): Silberstein headache
protocol (25 units) + upper trapezii (37.5 units
each).
Postinjection (11/00): Reported (first time in 11
years) being completely headache-free for 3 weeks.
•
•
VAS:7/10; FIQ:63.5/90: 18/18 TeP.
(02/01) After 2nd Botox (200 units): VAS: 0/10.
FIQ:53/90.
She subsequently moved out-of-town and was
lost to further follow-up.
Patient Profile #3
A 46-year-old married church worker and mother
of two, church worker with FMS, IBS, and migraines. Taking bellergal, codeine, dicetel and
ginger, echinacea, milk thistle, garlic, vitaminE,
coEnzymeQ10. Risk factors: childhood abuse with
alcoholic parents; iv drug abuse (hepatitis C diagnosed in 1995). Car accident (1989) with whiplash, right frozen shoulder.
Initial examination (06/00): 5′4″,114 lbs. No
anemia or jaundice. BP134/99 mmHg.
•
•
•
VAS: 5/10, SFMcGill: 25/45, FIQ: 57/100.
Pain Disability Index (PDI): 30/70. 18/18 4+
TeP (1-1.5kg.)
Treated with hydrotherapy, gabapentin (slowly
up to 2400 mg/day). Weaned off codeine,
bellergal.
Volume 17 Issue 1
VAS:3/10. SFMcGill:7/45. PDI:11/70.
FIQ:14/100. 8/18 TeP.
Patient Profile #4
A 45-year-old right-handed psychiatrist, while
lost hiking (carrying 5-year-old daughter and 15-lb
infant), developed bilateral arm pain and numbness. After 1.5 years of unsuccessful physiotherapy,
craniosacral osteopathy, acupuncture, NSAIDs,
and cortisone injections, he was referred with
“medial epicondylitis, thoracic outlet syndrome
(TOS), FMS.” Past health included migraine,
anxiety, IBS. Family history included alcoholism,
thyroid disease, lung cancer and polio (2 siblings).
Initial examination (12/99): 5′10″, 155 lbs.
•
•
•
•
•
BP 110/70 mmHg (both arms).
Tender epicondyles with positive Cozen’s sign.
1-2+ 12/18 TeP. Normal motor, sensory, reflex testing. Positive left brachial plexus tension, adson’s and allen’s tests (using portable
doppler). No subclavian bruit.
Jamar grip strength—left: 75 lbs, right: 95 lbs.
VAS pain: 4/10. PDI: 25/70 with limitations
in writing, recreation, gardening.
Normal investigations included (1) nerve conductions of median, ulnar (including F-wave),
medial antebrachial cutaneous motor/sensory
nerves, and needle EMG of left arm myotomes; (2) bloodwork; (3) ultrasound of elbows.
(4) MRI C-spine (minimal disc bulge C5-6).
Arm doppler photoplethysmography confirmed
vasculogenic TOS: severely decreased amplitudes
7
bilaterally with 180° hyperabduction and moderate with left costoclavicular and Adson’s tests. No
thrombus noted on color duplex imaging.
•
•
Subsequent therapy (spray-and-stretch, EMG
biofeedback, home exercises) alleviated right
arm pain.
A persistent left scalene medius TrP was then
injected with 1% procaine. His pain diary
recorded VAS 4/10 down to 1/10 for a few
hours. Pain was back to 4/10 by the morning.
(Figs. 1 and 2)
Further injections, combined with therapy,
provided 1 to 2 weeks relief only.
EMG guided injection with 35 units of Botox
(15-11/00) was done next, followed by electromuscular stimulation (Childers’ protocol).
One month post-Botox: VAS: 1/10. PDI: 5/70.
Left grip: 100 lbs. 1+ 5/18 TeP.
At 3 months, he described his left arm as
being 90% improved with Botox. A second
injection (24-03/01) with 50 units Botox resulted in 95% improvement. A year later, he
returned for trigger point lidocaine injections
FIGURE 1. Case study #4. Peripheral Doppler studies demonstrated Thoracic outlet compression on the left,
implicating scalene/pectoral tightness.
8
Critical Reviews™ in Physical & Rehabilitation Medicine
FIGURE 2. Pain diary reveals good short-term physiological response to lidocaine injection and predicted positive
response to Botox.
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9
into the trapezii. He returned on 23-04/04 for
consultation on a right rotator cuff tendonitis
and reported no ongoing TOS symptoms with
daily stretching.
Patient Profile #5
46-year-old single mother of one and registered
nurse had a pituitary brain tumor excised in 1988.
She was placed on hormone replacement therapies, gained 176 lbs in one year and developed
widespread tenderpoints. She underwent her first
Botox treatment in January, 2002, and her seventh in April, 2004. She reported that with Botox
she can work full-time, walk upstairs, sleep better,
and is more able to garden and do housework. She
noted less fatigue, irritability (with her teenage
son), depression, and social withdrawal (Fig. 3 and
statistics below [Table 6]).
Patient Profile #6
A 53-year-old woman had post-traumatic head/
upper facial pain after a car accident in 1989. CT/
MRI scans were normal. Over the subsequent 10
years, she had 12 surgical procedures, including open
C2 ganglionectomy, cervical facet rhizolyses—3 times,
C2 neurotomy (dorsal ramus medial branch), right
temporal artery excision, bilateral supraorbital nerve
resections, and percutaneous microballoon compression of the gasserian ganglion.
Despite palliative nerve blocks from the referring anesthesiologist, she still complained of daily
bifrontal headaches radiating to the upper shoulders and dorsal neck. Topamax was added to
medications which included Paxil, Oxycontin,
Stemetil, Amitriptyline, Ibuprofen, Losec.
Physical examination revealed hypoesthesia
in the forehead and C2 distribution. Tenderness
was most noted on the upper trapezii, frontalis and
paracervical muscles. She had 18/18 tender points
and fit the ACR criteria for FMS.
Botox injections administered to the pericranial (frontalis, corrugator, procerus, temporalis)
and trapezii muscles showed good response, supported by outcome measures and surface EMG
recordings (see Table 5).
Her FIQ score before Botox was 51.4/90.
One month after her 10th injection set (Jan.,
2004), the FIQ was down to 14.8/90. With
FIGURE 3. Case study #5. Botox injection for low back pain.
10
Critical Reviews™ in Physical & Rehabilitation Medicine
TABLE 5
Outcome measure
Preinjection
One month
post-3rd injection
7/10
92/100
68/78
33/50
4/10
84/100
58/78
28/50
Visual analogue scale pain
Headache Disability Index
Headache Impact Test
Vernon-Mior Questionnaire
Surface EMG RMS
amplitudes (uV):
Left
Right
Left
Right
2.24
6.97
6.84
3.99
4.54
6.73
1.44
1.51
1.90
0.96
0.98
1.34
15.07
5.36
5.47
4.12
5.20
2.44
2.24
3.10
Frontalis
Sitting at rest
Cervical lateral flex
Cervical rotation
Trapezius
Standing at rest
Cervical rotation
Botox, she reported that she can go shopping and
carry 10 lbs (milk, potatoes), do laundry, dishwash,
and stand one hour to cook. Her husband observed that she can do ironing without complaining of pain. Further injections have been carried
out every 3 months for 11 sessions to date without any significant complications. She estimates
it alleviates pain by 75% and is able to reduce her
Oxycontin (Fig. 4).
Table 6 is a case series of recent fibromyalgia
patients who had repeat Botox injections. Prior to
these injections, all patients had gone through
extensive courses of traditional medications and
physiotherapy and had tried numerous CAM
therapies. Those with failed surgery syndromes
(for pain) are marked “᭙”, and those with pain
after motor vehicle accidents are marked “mva.”
Further information on these patients is posted at
FIGURE 4. Case study #6. Botox injection for headache or neck pain.
Volume 17 Issue 1
11
12
Critical Reviews™ in Physical & Rehabilitation Medicine
Age/sex
45/F
39/F
30/F
44/F
47/F
66/F
39/F
50/F
47/F
51/F
35/F
31/F
44/F
49/F
Patient
᭙ = had
surgery
1. BM᭙
2. AS: details in case #1.
3. LL mva
4. CL details in case #5.
5. SL mva
6. LM
7. CV
8. LB᭙
9. JB Crohn’s
10. BG
11. LB᭙
12. PF᭙
13. SMP
14. BN
Occupation
Nurse
French Tutor
Office Worker
Public Health Clerk
Banker
Banker
Homemaker
Part-time clerical
Legal secretary
Chiropractor
ICU Nurse
Asst. Crown Attorney
Personal Support Worker
Material Handler
TABLE 6
Case Series of 25 Fibromyalgia Patients
4
2
4
5
3
4
4
8
6
3
8
4
7
12
# of Botox
injections
24/10/02
100 units
27/05/03
100 units
10/03/03
100 units
25/02/03
100 units
28/05/01
100 units
07/07/03
300 units
31/07/03
200 units
08/04/03
100 units
30/09/02
100 units
04/02/03
50 units
21/01/02
100 units
04/02/03
100 units
03/04/00
200 units
11/12/00
100 units
First
injection
(d/mo/yr)
26/08/03
300 units
28/10/03
100 units
17/09/03
200 units
20/04/04
500 units
29/10/03
(after 2 yr gap)
200 units
20/04/04
400 units
27/04/04
300 units
27/04/04
500 units
06/04/04
200 units
20/04/04
100 units
20/04/04
500 units
18/11/03
400 units
24/02/04
(after 2 yr. gap)
200 units
04/02/04
300 units
Latest
injection
(d/mo/yr)
27/45* 6/10
21/45* 6.5/10
66.2/100 8/10
82.9/100 7/10
57.5/100 8/10
78.1/90 10/10
72.7/80 8/10
83.2/100 10/10
84.7/100 10/10
46.4/100 3/10
89/100 7/10
79.2/100 10/10
69.4/90 10/10
81.6/100 8/10
Scores before
Botox
FIQ & VAS pain
4/10
21/45*
11/45*
41.8/100
18.5/100
22/100
55.8/90
51.4/80
68.7/100
17.1/100
13.7/100
44.3/100
56.5/100
4/10
2/10
4/10
3/10
4/10
5/10
4/10
4/10
2/10
1/10
4/10
4/10
11.3/90
4/10
(after 1st BTX)
50.2/100
Scores 4–6
weeks after
last Botox
Volume 17 Issue 1
13
31/F
42/F
28/M
17. JM᭙
18. KB
19. ES
44/F
55/M
45/F
45/F
22. BC
23. FV᭙
24. mva
25. mva
Accountant
Social worker
I.T.
Manager
Financial
Advisor
Clerical Work
Homemaker
Financial advisor
Healthcare worker
Dentist
Admin. Asst.
Homemaker
5
7
7
3
9
11
6
3
3
6
5
Note: Some patients completed only the *Short-form McGill Pain Questionnaire.
46/F
21. BK details in case #3.
53/F
44/F
16. GH᭙
20. KB᭙ details in case #6.
mva
53/F
15. CA
14/01/03
100 units
27/04/01
100 units
27/06/02
100 units
12/05/03
200 units
10/12/01
100 units
17/07/01
100 units
25/11/02
100 units
13/04/03
100 units
26/08/03
100 units
27/05/03
100 units
25/02/03
100 units
13/01/04
500 units
16/03/04
300 units
20/04/04
200 units
15/12/03
400 units
06/04/04
400 units
20/04/04
400 units
09/02/04
500 units
13/01/04
200 units
18/11/03
200 units
02/03/04
200 units
25/05/04
200 units
66.9/90 10/10
77.2/100 8/10
80.3/90 9/10
27/45* 9/10
57.0/100 5/10
51.4/90 6/10
40/45* 10/10
76.9/100 8/10
3/45* 5/10
55/100 9/10
55.4/70 9/10
42.5/90
7.7/100
34.9/90
6/45* 6/10
6.7/100
14.7/90
32/45*
32.7/90
2/45* 2/10
39/100
18.9/70
2/10
1/10
2/10
2/10
2/10
4/10
3/10
5/10
1/10
http://www.musclepainrelief.ca/ and is the subject
of a forthcoming paper.
B. Discussion of Botox Treatment
One previously published study on Botox for
FMS found it not to be effective.127 This was a
small study of 10 patients who underwent alternate injections of lidocaine or Botox only into
the upper trapezii. Only one patient reported
relief of pain for 2 weeks, and that was with
lidocaine. On the other hand, several earlier
studies have demonstrated clinical effectiveness
for myofascial pain,128–131 including more recently published, randomized double-blinded
placebo-controlled trials (RCT).132,133
Injections into the trapezius may exacerbate
pain in FMS patients, particularly in the presence
of a head-forward posture with depressed scapulae
and thoracic outlet syndrome symptoms (painful
paresthesias in the arms and hands). Weakening
this scapula elevator will aggravate the tension on
the brachial plexus. Instead, injections into the
tight pectorals and levator scapulae muscles, combined with scapular stabilization exercises
(strengthening the trapezius, rhomboids), results
in a much better clinical response.
Botox has also been demonstrated to be effective in treating headaches (migraine, tension, and
cervicogenic types),134–137 FMS patients who also
suffer from migraine,138 and low back pain.139 A
published RCT found paraspinal injections of Botox
to be effective for chronic mechanical low back
pain.140 Laboratory research provides an explanation for Botox in pain control. This includes inhibition of calcium mediated release of Substance P
in dorsal root ganglion neurons,141 as well as in the
brain and trigeminal nerve endings.142,143 Botox
also inhibits other pain neurotransmitters, such as
vasoactive intestinal polypeptide144 and calcitonin
gene-related peptide,145 and by elevation of enkephalins at the dorsal horn of the spinal cord.146 In
a rat formalin model, Botox was found to have
dose-dependent anti-inflammatory effects,147 with
the mediator likely to be glutamate.148,149
Fos expression in the dorsal horn was also
inhibited.150 On the basis of this finding, we have
found that effectiveness in neuropathic pain control with intradermal injections of Botox is to be
14
expected.151 152 Clinical experience also suggests
that the duration of pain relief outlasts the musclerelaxation effect.153 The literature validates the
clinical effectiveness for Botox in appropriately
prescreened patients.
IV. TYPICAL APPROACHES TO THE
FIBROMYALGIA/CHRONIC PAIN PATIENT
A. Thorough Internal Medicine Work-up
It is necessary to rule out other similar and/or
concomitant disorders (hypothyroidism, polymyalgia
rheumatica,154 lupus,155 multiple sclerosis, polio,156
cancer, etc.). Prolonged morning stiffness and limited lumbar spine motion in more than one plane
is more indicative of other rheumatologic diagnoses.157 A workup should include a detailed neurological exam to assess for signs of upper motor
neuron dysfunction (hyperreflexia, babinski sign,
clonus, abnormal coordination, and gait).158,159
Case A (Fig. 5)
One 38-year-old male patient previously treated
with numerous therapies, including cortisone injections and paravertebral nerve blocks, was found to
have marked denervation in the thoracic paraspinal
muscles on needle EMG. Subsequent MRI scan
revealed an intradural extramedullary schwanoma
with compression of the spinal cord. Surgical excision resolved all his “FMS” symptoms (see patient
pointing to surgical scar in Fig. 5).
Other successful neurosurgical cases (with resolution of “FMS symptoms”) include those for an
intracranial ophthalmic artery aneurysm, colloid
cyst, and pituitary adenoma. A comprehensive
medical work-up should always be done to rule out
more serious diseases.160
B. Patients Should Have Already
Completed a Full Trial of More
Conservative Treatments
Conservative treatments include amitriptyline,
cyclobenzaprine, NSAIDs, physiotherapy (osteopathy, aerobic exercise, aquatherapy), and psychotherapy (cognitive–behavioural). In our menopausal
Critical Reviews™ in Physical & Rehabilitation Medicine
FIGURE 5.
Case example A.
patients, hormone replacement therapy may resolve symptoms all together.161 Some patients also
exhibit autonomic dysfunction162 and may respond
to biofeedback retraining.
C. Patients Should Be Followed and
Supported If They Elect to Try
Alternative Therapies
Our approach (following Dr. Dietrich Klinghardt’s
paradigm) categorizes CAM into four areas:
Biochemical
Psychoemotional
Volume 17 Issue 1
Researchers have found success with structural
CAM therapies such as prolotherapy. This involves injections into the bone–ligament interface
(which stimulate further fibroblast activity), collagen deposition, and ligament healing. A recent
RCT demonstrated significant improvement in
both the saline and the dextrose injection groups.163
This has led to the recommendation by Nikolai
Bogduk that such injections be considered in the
first-line management of chronic low back pain.164
Case B
Neurological
Structural
1. Structural CAM
A 45-year-old, married computer worker (see Fig. 6)
with diffuse pain worse in the low back was seen
in November, 2000. Clinical exam revealed old
polio (atrophic small flail right arm and shorter,
thinner left leg), 18/18 TePs and marked tenderness in the left sacroiliac (SI) region. 2+ laxity was
noted with the shear test for SI instability. Nerve
15
root tension tests were negative, and EMG revealed only chronic neurogenic changes. Bloodwork
and bone scan were negative for active sacroilitis.
VAS pain
Short-form McGill Q.
Pain Disability Index
Oswestry LBP score
Algometry FMS
average pain
Pre-Rx
Post-6th Rx
(06/01)
8/10
24/45
44/70
37/50
2.13 kg
4/10
19/45
24/70
15/50
3.0 kg
After trials of physiotherapy, chiropractic, and
orthotics (for leg-length correction), prolotherapy
injections with P2G (phenol-glycerine-glucose)
and lidocaine were administered to the SI ligaments on a monthly basis.
The patient returned 2 years later for a tennis
elbow complaint and was pleased to report continued back pain relief.
2. Psychoemotional CAM
Neurotherapy uses an EEG recording system, along
with training software, to enhance brain wave
activity that is instrumental for improving concentration. Much of the research has been focused on
children with attention deficit disorders.165
Case C
A 48-year-old, married dog breeder (see Fig. 7)
developed FMS, with chronic pain, cognitive difficulties, severe depression, and generalized anxiety, after an MVA in 1999. After numerous
therapies and medications, she was told that she
had reached maximum recovery. She started neurotherapy/biofeedback (20 sessions from March to
Sept., 2003).
After 10 sessions, she estimated 75% improvement. She noted that “I can laugh. I am awake
again and feel as if I am reborn.” After 20 sessions,
she was 95% improved and noted that whatever
was left in terms of her concentration deficits was
just what “people normally face at this age of life.”
She could socialize more and engage in various
activities with her son and husband.
Outcome measures
Pre-Rx
Post-Rx
VAS pain
Beck anxiety score
Beck depression
Perceived deficits scale
Fatigue severity scale
Fibromyalgia Impact
Questionnaire
7/10
11/63
26/63
69/80
42/63
65/90
2/10
2/63
8/63
22/80
13/63
19/90
3. Biochemical CAM
FIGURE 6. Fibromyalgia polio patient improved with
prolotherapy.
16
Improvements have been reported in some patients
through nutritional/ naturopathic interventions.
Those with irritable bowel syndrome can be helped
Critical Reviews™ in Physical & Rehabilitation Medicine
FIGURE 7.
Fibromyalgia patient with “brain fog” improves with neurotherapy/biofeedback.
with elimination diets. A young patient was 90%
improved by eliminating tartrazine (in red dyes to
color meats) from her diet. Recent reports also
suggest a link between FMS and type 2
diabetes,166,166a, 166b thus supporting the recommendation of a hypoglycemic diet (ie, low intake of
processed, refined carbohydrates and sugar). Deficiencies have been shown in omega 3 fatty acids167
and in vitamin D.168,168a There are also reports of
heavy metal toxicity, treatment with amalgam
removal and neural therapy.169,170 There is a report
of a dozen patients who have done extremely well
with the Dr. St. Amand’s protocol. (Paul St.
Amand is an endocrinologist and assistant clinical
professor of medicine at UCLA).171 This requires
oral guaifenesin that is titrated to promote renal
excretion of inorganic phosphate. Strict dietary
changes, including avoidance of salicylates (including most brands of toothpaste), is required for
this to work. However, a good randomized controlled trial has yet to be done.172
Case D
A 54-year-old, married, retired, left-handed IBM
consultant had FMS for 15 years. Risk factors
Volume 17 Issue 1
included childhood growing pains and hypermobility, left elbow fracture, and right knee
arthroscopy for osteoarthritis. Her mother had
Charcot-Marie-Tooth disease (the patient, herself, was self-tested negative). She had extensive
dental work and rows of amalgams and root canals. She also had hypertension for 2 years. Her
best exercise tolerance was going on a treadmill
1.9 mph for only a few minutes.
Pretreatment: (January, 2002)
18/18 TePs. VAS: 9/10 FIQ: 71.7/90
She could not write and could only climb stairs one
step at a time. She could not drive because her
neck was stiff and she often felt dizzy. She had
chronic constipation and severe migraines 2 to 3
times per month.
Initial treatment included naturopathic evaluation and general detoxification (homotoxicology approach). After a month of this, she
started guaifenesin capsules 300 mg per day.
This was titrated up to 900 mg BID.
July, 2002: 18/18 TePs. VAS: 2-8/10 FIQ:
48.4/90.
17
Overall, she felt 35% improved and was able, for
the first time in years, to play 5 rounds of 9-hole
golf. She continued on oral guaifenesin and salicylate avoidance.
Jan., 2003: 13/18 TePs. VAS: 1-7/10
She could carry heavy laundry upstairs and exercise on a treadmill 3.2 mph for 30 minutes, 3
times a week. She was able to do bicep curls with
7.5 lbs barbells.
Sept. 9, 2003: 13/18 TePs. VAS: 1-6/ 10 FIQ:
12/90
She played 35 rounds of 18-hole golf in the past
summer. She regularly did heavy gardening and
could sweep her driveway with a heavy broom. She
only had light headaches, 1 to 2 times per month.
A phone call check on April 21, 2004, revealed
continued significant symptom reduction and high
level of function [Fig. 8 ].
The use of CAM must be monitored for
adverse effects and potential interactions with
medications. As a general rule of thumb, all herbal
products should be stopped (blood thinning effect)
prior to any surgery or extensive and/or deep softtissue injections.
patients with FMS or CFS differ from those with
major depression.174 Axis one psychiatric disorders, including “hysteria-conversion disorders,”
should also be excluded. Patients involved in stressful disability claim appeals and litigation ideally
should have such issues resolved prior to initiating
treatment. More detailed evaluation should first
be completed.175
D. Pain Control Is an Important First-Line
Goal in FMS Patients
Patients with mild pain (<4/10) are usually able to
participate in CAM therapies (including nutrition,
exercise, mind-body programs). Those with more
severe pain (>7/10) are often unable to do so and
may require stronger pharmaceutical approaches
first. This includes long-acting opioids and adjuvants, such as alpha-2 receptor agonists (tizanidine),
anticonvulsants (pregabulin, gabapentin), cannabinoids (nabilone). Recent cardiac concerns about
Cox-2 inhibitors have limited use of NSAIDs for
chronic pain. As discussed, Botox in patients able to
undergo injections may be a safer, well-tolerated
approach to control severe pain.
1. Preinjection (Botox) Screening
4. Beck Depression Inventory Score
Should Be Less Than 21/63 Prior to
Undergoing CAM Pain Treatments
Higher scores indicated major depression, which
should be treated first.173 Studies suggest that
FIGURE 8. Naturopath using electrodermal acupuncture technology to assist in this patient’s detoxification.
18
Relative contraindications to injection treatments
include
Needle phobia
Lack of motivation; unwilling to comply
Coagulopathy or use of blood thinners
Pregnancy
Unstable medical or psychiatric condition
With Botox, injections should not be administered to patients with flu symptoms, or to those
who are on aminoglycosides or have neuromuscular junction disorders (Myasthenia Gravis, EatonLambert syndrome, myopathies). It is also recommended to not inject into atrophic, flaccid muscles.
If all the above are satisfied, then a further
optional screening step is a test TrP injection(s)
with preservative-free hydroxide-buffered 1%
procaine or lidocaine (see patient profile #4 above).
This has the advantage (over regular anesthetics) of
Critical Reviews™ in Physical & Rehabilitation Medicine
a much lower likelihood of postinjection soreness /
allergic reaction. Patients return after one week
with a completed pain diary. If there is increased
pain or no pain reduction, then further Botox
injection should not be administered in the same
sites. If there is a significant reduction in pain (VAS
decreases over 2 points or by 30%),176 Botox would
be indicated. Informed consent and follow-up with
validated outcome measures are necessary.177
3. Inject with Anatomical/Biomechanical
Reasoning240,242
•
•
•
2. Botox Injection Tips
•
In some patients with dermatographism, a course
of antihistamines prior to and after injections will
help to prevent flare-ups.178 Recent research suggests that higher levels of cytokines in the skin are
the explanation for the skin allodynia found in 27
to 38% of patients.179 Vitamin C (500 mg per day)
has also been recommended for bruising.180 Anticoagulants should be discontinued prior to extensive needling or injections. Temporary flu-like
illness, lasting a week, is possible. Some patients
note increased pain, probably from overzealous
injection of numerous TrPs.
For the first-time FMS patient, it is best to go
“low and slow.” Only two sites at most should be
infiltrated initially (usually the levator scapulae or
pectorals), and, then, further TrP gradually injected later. If there is marked skin hyperalgesia,
injections should be done quickly (no needling or
fanning-out technique) with a smaller gauge needle
(27 gauge). Postinjection physiotherapy should
also be done.
Patients with marked hypersensitivity, that is,
grade 4 tenderness (the grading system recommended is: 0= no pain, 1 = complaint of pain
without grimace, 2 = pain with grimace or flinch,
3 = pain plus marked flinch or withdrawal, 4 =
“untouchable”181) and/or all algometric pain thresholds below 2 kg., should first try intradermal
injections. Such patients may actually have generalized complex regional pain disorder and are
more likely to flare up if injected too aggressively.
Overzealous injections in the painful areas, as well
as unnecessary surgery, cast immobilization of an
extremity, and repeated sympathetic blocks (in
late stages) only aggravate this condition.182
Gabapentin slowly titrated up to 2400–3600 mg
per day may be more helpful.
Volume 17 Issue 1
•
•
•
•
Head: Avoid area above lateral eyebrow (diffusion to levator palpabrae and subsequent ptosis)
Posterior Neck: Avoid suboccipital midline (foramen magnum) and deep rectus capitis muscles
(proprioception disturbed)
Anterior Neck: Avoid anterior triangle (diffusion to swallowing muscles, neurovascular structures). Scalene injections with EMG guidance
only.
Shoulders: Avoid scapular stabilizers (rhomboids, middle and lower trapezius) and supraspinatus (results in loss of arm abduction
ability). Minimize upper trapezius injections
in dropped scapula (upper edge well below T2)
(Fig. 9).
Thoracic: Avoid iliocostalis and longissimus
thoracis in kyphotic patients.
Low back: Avoid lumbar paraspinals in
hyperlordosis.
Spine: Avoid midline (inadvertent intrathecal
entry).
Limbs: Watch dosage. Too high a dose will
affect function, for example, quadriceps and
gait, forearm extensors and finger/wrist extension, grasp.
Other precautions with Botox injections:
Scalenes and other accessory respiratory
muscles: asthma, chronic obstructive pulmonary
disease, sleep apnea (note that 44% of males with
FMS have underlying sleep apnea).240
Pectorals: breast implants, pacemakers
Hypermobility: Inject only the pericranial
muscles initially(avoid destabilizing the spine)
(27% of FMS females have hypermobile joint
syndrome).241
Avoid open wounds, shunts, deep injections
near viscera, pleura.
E. Long-Term Management
of Fibromyalgia
There is no universal “magic bullet” for the treatment of FMS. It is a syndrome and not a specific
pathological disease entity. Diagnosis is made by
19
FIGURE 9. Physiotherapist demonstrating dropped left scapula in patient #17 (Botox case series listed above) whose
post-traumatic “FMS” symptoms resolved after 3 injection series combined with appropriate exercise therapy.
exclusion (the usual lab tests are all negative).
Symptoms may last an average of 15 years.183
Review papers suggest that positive outcomes occur not only with age184 but also with an adequate
physical activity level185 and coping skills.186 Excess major negative life events and permanent
disability pensions are associated with a negative
outcome.187 Younger age of onset and less sleep
disturbance are associated with a more favorable
outcome. 188 Effective management is best with
an interdisciplinary approach 189–191 emphasizing
lifestyle improvement (“TENSQ”: Toxin elimination, Exercise, Nutrition, Sleep hygiene, Quiet
“de-stress” time) and pain control (ETPS
“TENS”192 and other home modalities). FMS
smokers have also been found to have more pain,
numbness, global severity, and functional difficulties than nonsmokers. 193
Other studies also indicate that 67% of patients experienced migraine prior to the onset of
their FMS,194 and that 25% of chronic low back
pain patients will evolve into FMS.195,196 Perhaps
Botox, shown to be effective in these conditions
could also be used to prevent the development of
FMS. After all: “prevention is better than cure.”
20
V. CONCLUSION
This review has not only summarized published
peer-review literature on pain management in the
area of fibromyalgia but has also presented 20
years of clinical experience in managing such
patients. Most studies of CAM effectiveness are of
poor quality (few are of high quality according to
the Jadad criteria). One recent extensive FMS
review paper listed 433 references.197 Out of this,
only 10 references applied to CAM trials. However, it must be realized that CAM (non-drug)
clinical trials are often difficult to implement in a
true blinded fashion.198 Research is needed all the
more , noting that CAM use is among the highest
in this difficult-to-treat group of patients.
As noted in the typical case studies, effective
CAM therapies include naturopathic medicine,
guaifenesin, neurotherapy, and prolotherapy. Perhaps the most promising treatment to date for
pain control is the use of Botox. Integrating this
treatment with other CAM approaches may also
be useful.199 From an evidence-based perspective,
there is obviously a need to do a randomized
controlled double-blinded study using Botox in
Critical Reviews™ in Physical & Rehabilitation Medicine
FMS. It is hoped that this review will stimulate
further research in FMS management. Ultimately,
“Doing everything for everyone is neither tenable
nor desirable; what is done should ideally be
inspired by compassion and guided by science, and
not merely reflect what the market will bear.”
(from Grimes DA. Primary prevention of ovarian
cancer (editorial). JAMA, 1993;270:2855).
9.
10.
11.
ACKNOWLEDGMENTS
Dr. Ko would like to thank the following for their
help with this review: Michael Jokic (4th-year
University of Toronto student) for his assistance in
data collection and in the CAM survey of FMS
participants and Pablo Diatel BSc(Kin) (Biofeedback kinesiologist with Global Managed Healthcare) for his contribution in assessing patients
before and after Botox injections. Further information and resources are also available on Dr. Ko’s
education website at www.MusclePainRelief.ca.
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APPENDIX
Jadad Criteria for Clinical Trials on Pain Treatment
(Adapted from Ezzo J. Pain 2000;86:217–225.)
Evidence for a clinical trial on pain treatment is weighted as follows:
Score 1 for each:
A. Was the study described as randomized?
B. Was the randomization scheme described and appropriate (e.g., table of random numbers or
computer-generated randomization not appropriate for alternating allocation, date of birth randomization)?
C. Was the study described as double blind?
D. Was the method of double blinding appropriate?
1. Were patients reported as blinded?
2. Was the outcomes assessor reported as blinded?
E. Was there a description of dropouts and withdrawals?
Scoring: A + B + C + D + E = ___/5. A high-quality trial is 3 to 5.
Additional criteria:
F. Were co-interventions avoided or controlled for?
G. Was compliance satisfactory? (e.g., with home treatments)
H. Was the study population adequately homogenous? (conditions of similar etiologies/natural
histories)
I. Was the therapeutic time equivalent between groups (similar number and duration of Rx)?
In our review of the literature, high-quality treatment trials were noted for the following references: 67,
71, 86, 91, 99–101, 101a, 103, 108, 108a, 132–6, 140, 200–2, 204–5, 213, 217, 220, 223–4, 228–39.
30
Critical Reviews™ in Physical & Rehabilitation Medicine