|
The
Journal of Orthopaedic Medicine Vol 16 1994 No 3
TREATMENT
OF CONSECUTIVE SEVERE
FIBROMYALGIA PATIENTS WITH PROLOTHERAPY
K.
Dean REEVES,M.D.
ABSTRACT
The potential of
tendon and ligament triggers as primary nociceptors in fibromyalgia led to
treatment of primary fibromyalgia patients with
tendon and ligament strengthening injection. Trigger injection of ligament and
tendon with proliferant (TILT therapy or prolotherapy) offers the advantage of
creating increased strength of the connective tissue in the region of
injection as well as affecting the pain cycle. Reduction in pain levels and
increased functional abilities were seen in excess of 75 % of patients with
severe fibromyalgia in this study. The implications of this for further study
are considered.
INTRODUCTION
The search for
'central factors' in the cause of fibromyalgia has revealed evidence of
possible alteration of pain modulation in the body such as a decrease in
circulating serotonin and possibly antibodies that block serotonin receptors. 27,39
Evidence has also been found for central factors affecting soft tissue
homeostasis. (Possible glucocorticoid deficiency or deficient production of
growth hormone related factors. 3,14,24) Search
continues for the primary nociceptor in fibromyalgia. It is notable that the
classical tender points in fibromyalgia are over tendon and ligament
insertions. Semi-elastic tissues are generally recognized to be the sites of
acute damage in sprain and strain. 35 Tendon and
Ligament attachments to periosteum have the lowest pain threshold of any deep
somatic structure. 4 Inman and Saunders reported
stimulating periosteum in a variety of ways including pressure, and elicited
severe referred pain to muscles or bony prominences in the referral zone in
reproducible patterns. 23 De Valera, Gorrell, Hackett,
Kelgren, Kraus, Leriche and Travell have all described referral pain from
tendinoligamentous structures, with patterns of referral most meticulously set
out by Hackett. 8,12,15-22,25,29,40,41,42 Tendon or
ligament laxity or weakness has been proposed to cause chronic nociception via
inadequate skeletal support, intermittent stretch of fixed-length sensory
fibers, or development of myofascial trigger points. 19,35
The premise of this study is that weak or lax tendons or ligaments are
potential nociceptors in fibromyalgia and that this is potentially a
correctable nociceptor source.
Prolotherapy involves
injecting an area of ligament or tendon laxity or weakness with a solution
that stimulates fibroblast proliferation. The goal of proliferation therapy is
to restore normal connective tissue length and strength in the affected area,
and in so doing to restore adequate skeletal support and eliminate sources of
myofascial trigger perpetuation. 2 Borden demonstrated
the ability of a simple dextrose solution in 12.5% concentration or more to
create a prompt inflammatory reaction. 6 The simple
dextrose solution is thought to create irritation by an osmotic gradient.
Cells in the area lose water, and desiccate to the point of an injury
response. Animal studies have shown a 40% increase in diameter and strength of
injected tendons compared to contralateral tendons. 17,32
Changes persisted more than 12 months post injection and were not dependent on
any difference in exercise levels of the animals. Human studies have
demonstrated collagen fiber diameter increases and increased cellularity on
biopsy of injected areas. Disability, range of motion, and pain levels all
improved significantly in patients injected after 5 or more years of chronic
pain. 26 In human knees with reproducible ligamental
laxity as measured by a computerized knee analysis device, a statistically
significant reduction in ligamental laxity was demonstrated with a P value
less than 0.05. 37 Randomized double-blind control
studies with saline injected controls have demonstrated statistically
significant improvements in low back pain and disability rating in treated
patients compared to controls. 28,36
METHOD
Patient Population
Consecutive patients
with severe fibromyalgia were treated with tendon/ligament strengthening
injection. The fibromyalgia was sufficiently severe in each case that all the
patients desired intervention trial. All patients had experienced continuous
upper body, back, and lower body pain for more than 6 months, with average
duration 7 years and 10 months. Tender points were present in at least 7/9
classic regions on both sides of the body. Functional questionnaires indicated
that 37% had regular narcotic intake, sexual function was limited in 48%, arm
numbness made handling small objects difficult in 55%, 70% of patients had to
lay down during the day due to pain, lifting arms overhead increased pain in
70% of patients and bending, twisting and squatting frequently was intolerable
to more than 80% of the patients. Awakening from pain averaged 3.1 times per
night. Sitting tolerance was 33 minutes; standing tolerance 27 minutes; light
work tolerance 45 minutes; heavy work tolerance 19 minutes; and writing
tolerance l7 minutes.
Solution used
The solution used was made by combining 3cc of 50% dextrose with 2cc of 1 %
xylocaine (lignocaine) and 7cc of benzyl alcohol type bacteriostatic water,
making a dextrose concentration of was 12.5%.
Typical first
session
There are several 'methods' of prolotherapy, and two representative texts can
be referenced for details. 9,22 Because of the very
diffuse number of painful entheses, the method of injection was the meticulous
one of Hackett. 22,38 A typical comprehensive first
injection session for upper and lower body included the following numbers and
sites of injections, with 0.5 cc to 0.75cc injected at each site, assuming
both sides of the body treatment in almost all potential injection sites.
Semi-spinalis, splenius and rectus capitus insertions on base of skull (24);
cervical facet ligaments (14) ; cervical intertransversarii (28); posterior
superior trapezius insertions on back of clavicle (8); lateral costotransverse
ligament attachment to ribs (14); infraspinatus, teres major and minor
attachments to scapulae posteriorly (28); scalene attachments ant and post
tubercles (16); subscapularis, biceps and pectoralis insertions on anterior
portion of humerus (16); common extensor attachments at elbow(6); lumbar
intertransversarii (10) ; lumbar facets (10); lumbosacral junction (6 with
several needle redirections) ; Crest of ilium (6); iliolumbar ligament (4 with
several needle redirections); SI ligament (6 with several needle
redirections); gluteus maximus, medius and minimus insertions on iliac bone
(30); deep articular ligaments of hip (6 with several needle re-directions);
external rotator and gluteii attachments posterior trochanter (24); distal
adductor attachments knee (2); hamstring attachments in anserine bursa (16).
It can immediately be seen that this is a time consuming and exacting
procedure when done comprehensively. The volume of solution used can be as
much as 200cc with treatment, but the concentration of Xylocaine in the
solution of less than .2%, coupled with the length of the procedure causes no
problems in terms of anesthetic toxicity.
Sedation
Oral vistaril (hydroxyzine) was used for nausea prophylaxis to avoid rare
anaphylaxis with compazine. An anesthetic gun was used to numb the skin in all
patients who preferred it to the needle insertion sensation. Intravenous
demerol (pethidine) was used as the exclusive sedation except for those with
demerol allergy or with prolonged nausea after demerol use. Valium (diazepam)
was added or used exclusively when demerol was not feasible as a sole agent.
Continuous oximetry was used with an office attendant present to ensure
oximetry values above 87% and regular breathing patterns. Narcan (naloxone)
was immediately available. It is important to note that demerol should be
titrated in 25-50mg increments for first one to two sessions. Careful record
keeping should allow determination of ideal amounts for sedation by session. 3
Oximetry or close observation of breathing patterns was considered
particularly critical with use of 40mg of demerol or more in the elderly or
75mg or more in the young. Demerol was titrated with first the first one to
two sessions to determine the patients' reaction and careful records kept as
to ideal amounts for future reference. Note that the reason for significant
amounts of demerol was the substantial time period required for comprehensive
injection.
Injection
follow-up
Because of healing cascade length of 8 weeks, follow-ups were scheduled at
that interval in general, though other pain areas may have been treated in the
interim. At follow-up, pain areas and palpation determined areas of injection.
All sore areas to palpation were not reinjected, but rather potential trigger
areas for current pain were addressed. Patients received an average of 3.5
injection sessions to any particular pain region.
Questionnaire use
Questionnaires were sent out to all patients who had received one or more
treatments, with the first treatment occurring at least 6 months before
questionnaire mailing. This questionnaire asked about pain levels pre- and
post- treatment by body region. Other questions requested assessment of
overall frequency and intensity of pain, and tolerance of sitting, standing,
walking, sleeping, light work, and heavy work. Patients were also asked to
compare tendon/ligament strengthening injection to other treatments they had
received in the past, and asked about complications. If questionnaires were
not returned, follow-up 'phone contact confirmed if one was received, and the
patient was encouraged to return the questionnaire. 'Phone interviews were
decided against to avoid leading the answers. 31 of 40 consecutive
fibromyalgia patients returned follow-up questionnaires, or 78% of the
patients so treated.
RESULTS
Table 1 depicts the
average pain levels of the 31 patients by area, using a 10 point scale with
'10' the worst pain imaginable and '0' being no pain at all ever. The 16
regions chosen were rated at 4.86 out of 10 pre-injection and 3.30
post-injection for a reduction of 32.1 %. All regions of the body were noted
to have less average pain after injection.
|
Region
|
Average Pain before RX
|
Average Pain after RX
|
|
Head
|
5.81
|
3.77
|
|
Neck
|
7.00
|
4.45
|
|
Front of Shoulder
|
4.52
|
3.03
|
|
Top of Shoulder
|
5.68
|
3.55
|
|
Back of Shoulder
|
7.03
|
4.26
|
|
Elbow/Forearm
|
3.52
|
2.26
|
|
Wrist/Hand
|
3.00
|
2.00
|
|
Upper Back
|
6.23
|
4.03
|
|
Front of Chest
|
4.10
|
2.81
|
|
Mid Back
|
6.71
|
4.77
|
|
Low Back
|
6.77
|
4.90
|
|
Buttock/Hip
|
5.42
|
4.26
|
|
Thigh
|
3.94
|
2.81
|
|
Knee/Calf
|
3.10
|
2.42
|
|
Ankle
|
2.19
|
1.81
|
|
Foot
|
2.68
|
1.7
|
|
Whole Body
(average of above)
|
4.86
|
3.30
|
Table 1
Pain before and
after tendon/ligament strengthening injection (prolotherapy)
Table 2 depicts the
functional outcome of injection. 21/31 patients indicated their pain frequency
was better, much better or gone, and 18/31 indicated their pain intensity was
better, much better, or none. The questionnaire asked for an explanation of
'worse' or 'much worse' responses, with reasons given of stress in 3/5, work
in 2/5, needing to follow-up with no insurance in 2/5, and don't know in 1/5.
Two of these patients had only one treatment. Improvement in sitting,
standing, walking and sleeping ability in minutes was noted to be about the
same for each. Of particular interest from a functional point of view was that
of the 30 patients indicating problems with tolerating light work,18 indicated
they were better or much better at tolerating light work, and 2 indicated they
tolerated light work less. The results were not so favorable for heavy work,
with 9 indicating they tolerated heavy work better and 6 less. The 6
indicating they were worse again gave "stress", "work",
"had to stop treatment", or "don't know" as the reason.
|
Levels
of Pain/Ability |
A: never a
problem |
|
B: back to
normal |
|
C: much better |
|
D: better |
|
E: same |
|
F: worse |
|
G: much worse |
SPACE
| |
A |
B |
C |
D |
E |
F |
G |
|
Frequency of Pain |
0 |
1 |
8 |
12 |
5 |
3 |
2 |
|
Intensity of Pain |
0 |
1 |
6 |
11 |
8 |
2 |
3 |
|
Sitting Ability |
0 |
2 |
5 |
10 |
10 |
4 |
0 |
|
Standing Ability |
0 |
2 |
3 |
13 |
6 |
6 |
1 |
|
Walking Ability |
1 |
3 |
2 |
12 |
6 |
6 |
1 |
|
Sleeping Ability |
1 |
2 |
4 |
6 |
13 |
4 |
1 |
|
Light Work Ability |
1 |
1 |
5 |
12 |
10 |
1 |
1 |
|
Heavy Work Ability |
0 |
1 |
1 |
7 |
16 |
4 |
2 |
Table 2
Functional results of tendon/ligament strengthening
injection;
changes post injection
Table 3 provides
results when patients were asked to compare the outcome of tendon-ligament
strengthening injection with any previous treatments they had received. They
were given a series of statements to choose from, and asked to pick the one that
described their opinion. Note that all patients (other than those unable to take
time off work for therapy) were offered 6-9 sessions of physical therapy for
postural exercise, stretching and massage instruction, instruction in proper
heat use, encouragement to walk, and amitriptyline or flexeril. 22/31 had
previously received physical therapy; 14/31 had previously received
manipulation; 6/31 acupuncture; and 17/31 massage. Of the 31 patients, 12
indicated that it was the only really effective treatment they had received, and
23 of 31 indicated it was more helpful than any past treatment. Patients were
asked to indicate their status with respect to future treatment, and were given
several responses to choose from.
|
Only really effective treatment
was injection
|
12/31
|
|
Injection was much more
effective than other treatments I have received
|
8/31
|
|
Injection was helpful but
effects did not last
|
5/31
|
|
Injection was more effective
than other treatments
|
3/31
|
|
Injection was as helpful as any
other treatment
|
1/31
|
|
Injection not as helpful as
other treatments
|
1/31
|
|
Injection not helpful
|
1/31
|
Table 3
Comparison of prolotherapy with other treatments previously received
Table 4 displays their
answers. Particularly notable was that of those not desiring follow-up at the
time of the questionnaire mailing, 6 were better or plateau, two did not
specify, and only one thought the treatment was too much to go through. Despite
the use of sedation and skin anesthesia with a jet gun, there is no way to truly
make this treatment pleasant. Patient tolerance of treatment was impressive,
however, in that only l/3l stated they were not continuing treatment because it
was too much to go through. Patients did need substantial support not only
during the treatment sessions which averaged 1 hour and 30 minutes in length,
but also between treatments with questions that arise. The implication is that
this treatment at this level of intensity would be impractical for the busy
clinician.
|
Follow-up planned because my
original pain needs to get better
|
21/31
|
|
I am enough better and don't
need treatment now
|
3/31
|
|
No treatment planned. I am as
good as I think I will get
|
2/31
|
|
No follow-up planned because I
am all better
|
1/31
|
|
Follow-up planned because new
pains have developed
|
1/31
|
|
Insurance or workman's
compensation does not cover treatment
|
1/31
|
|
Treatment is too much to go
through
|
1/31
|
|
I am not better. I don’t
think treatment will help
|
0/31
|
|
Other (Non specified)
|
2/31
|
Table 4
Follow-up plans post prolotherapy
When patients were
asked if they had any significant complications or side effects from treatment
they answered as in Table 5. Note that, of what would truly be considered a
complication, one had superficial phlebitis of a vein injected for sedation
purposes and one had a spinal headache. It is important to warn patients of
temporary new pains, variable pain periods after injection, small marks from
anesthetic gun if it is used, nausea, and, if injections are given over
posterior rib attachments, pneumothorax. In this practitioner's experience with
this particular injection method a symptomatic pneumothorax has occurred
approximately once each year when injections over posterior thorax average 100
or more per day - given the large numbers of injections in each session could be
significantly high if the clinician is not trained in angles to use, lengths of
needles to use, and depths of injection. Injections of arterial structures are
rare since injection never occurs unless bone is touched, and aspiration occurs
in critical areas such as the neck laterally. The amount of anesthetic injected
at any one time is substantially smaller than the smallest amount ever shown to
cause a seizure or cessation of respiration, even with direct vertebral artery
instillation. 5 Nerve damage has never been reported with use of dextrose
instillation and generally thin caliber needles used. If electrical sensation
occurs, however, the needle should be repositioned.
|
New pains for a while
|
11
|
|
Not specified
|
5
|
|
Vein irritated from sedative agents
|
1
|
|
Longer recuperation after some treatments
|
1
|
|
Spinal headache
|
1
|
|
Pain after injection
|
1
|
|
Appearance (Small marks from anesthetic gun)
|
1
|
|
Nausea for several days
|
1
|
Table 5
Side effects/complications of prolotherapy in severe fibromyalgia syndrome
A complicating factor in follow-up exam
of these patients is that the number of tender points diminished as symptoms
improved. Note that the 'tender points' were often injected during the course of
treatment. (i.e. common extensors elbow, distal adductors knee, cervical
paraspinals, costotransverse ligaments, upper trapezius).
DISCUSSION
There is an accumulating body of
evidence for peripheral soft tissue changes in fibromyalgia. An example would be
strong evidence for an increase in tissue compliance and reactive skin hyperemia
in fibromyalgia. 3 Searching in skeletal muscle has not
yielded consistent findings on biopsy, though changes of degeneration are often
seen. 10 Bennett postulated that a defect in repair
processes after micro or macrotrauma in fibromyalgia may prevent resolution of
such injuries, with development of chronic pathology. 3
Recent evidence has indicated that Somatomedin C (a growth hormone-related
factor important in musculoskeletal homeostasis) is deficient in fibromyalgia
patients. 3 Note that growth hormone-related factors are
secreted primarily during stage IV sleep and that stage IV sleep disturbance by
alpha wave intrusion is characteristic of fibromyalgia. 3,33,34
Jacobsen et al's finding of somewhat lower levels of Type III procollagen in
serum in fibromyalgia patients is interesting, in that procollagen is a critical
precursor in the healing of connective tissue. 24 The
healing cascade after semi-elastic tissue damage is critical in making the
ligament/tendon sufficiently tight and thick to continue normal function, but is
time-limited to 2-3 months after injury, and is dependent on adequacy of
fibroblast density, procollagen deposition, maturation to collagen, cross band
formation with shortening of the tendon and ligament laxity. 7
Injection of tendon and ligament triggers, since it includes anesthetic, may be
considered capable of having acupuncture effects or effects on breaking the pain
cycle; but acupuncture points were not specifically treated in this study, and
trigger injection with anesthetic alone has not been convincingly demonstrated
to be effective in allowing a sustainable improvement in function or pain level
in the presence of whole body pain of fibromyalgia.
With respect to the study patients,
there can be little doubt that they have severe fibromyalgia - given sitting and
standing tolerance less than 30 minutes, having to lay down during the day due
to pain in 70%, light work tolerance only 45 minutes, and intolerance of
bending, twisting, and squatting. In addition the average duration of whole body
pain of 7 years 10 months suggests strongly that spontaneous remissions to
marked degree would not be expected in this population and that spontaneous
worsening would be at least as likely. This is supported by Ledingham's long
term study showing 97% of patients persisting with symptoms, 85% still
fulfilling criteria after 4 years post onset, with 60% rating their symptoms as
worse and 26% better than at presentation 4 years post onset. 30
His study included fibromyalgia patients without severe functional impairment at
onset of study. Results in this study of resuming the healing cascade in areas
of proposed ligamental laxity indicate 33% pain reduction. This can mean that
the treatment is only partially effective, that there are perpetuating factors
preventing full resolution, or that the critical ligamental laxities were not
addressed.
Further studies are under way using
various combinations of ligaments. Functional status after treatment indicates
improvability of pain frequency and intensity, sitting, standing, walking and
sleeping. Since for most fibromyalgia patients a key goal is to keep working
with their disease, 18/31 experiencing improvement in light work ability and
2/31 a worsening is of particular functional significance. The rating of this
treatment by 22/31 as better than any previously received over the average 7
years of fibromyalgia and less effective in only 2/31 is encouraging for a
potential unique role of this treatment in refractory fibromyalgia.
SUMMARY
The improvements in pain levels and
functional ability after injection is supportive of tendon and ligaments being a
major source of symptomatology in fibromyalgia. In order to make this treatment
more practical further studies to determine the relative importance of various
ligament/tendon nociceptors in fibromyalgia will be important. In addition it is
hoped that this study will encourage basic science investigators to further
research homeostasis of connective tissue in fibromyalgia, as even microtrauma
of daily living in the presence of impaired homeostasis may sufficient to
explain onset of symptoms. The tendency of ligaments and tendons to refer pain
and numbness in non-radicular patterns and to inhibit muscular function to
create such symptoms as give-way weakness and a feeling of non-specific fatigue
could go a long way in explaining why physicians tend to mis-diagnose these
patients as having somatisation disorder. The lack of evidence for primary
psychiatric disorders as the cause for fibromyalgia has been set out in the
literature in a convincing fashion, but until the symptomatology of ligament and
tendon pathology is more widely recognized, the symptoms of fibromyalgia will
remain an enigma to most practicing physicians. 1
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