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The Pain Clinic

A Multidisciplinary Approach to Acute 6- Chronic Pain Management

Position Paper of the Florida


Academy of Pain Medicine on
Regenerative Injection Therapy:
Effectiveness and Appropriate Usage .

Voted and accepted by the Florida Academy of Pain Medicine membership at the
Annual Conference at the Hyatt Regency Tampa, Florida, on Saturday, June 30, 2001.

Position Paper Committee Raphael Miguel, MD, Professor and Sanford Pollack, D0, private practice,
Members: Chief of Anesthesiology Service, H. Jacksonville
Felix S. Linetsky, MD, private practice, Lee Moffit Cancer Center, Director of Albert Ray, MD, private practice,
Palm Harbor, Florida, Clinical Pain Management Fellowship Program, Miami
Associate Professor, Department of Family Professor of Anesthesia, University of
Lloyd Saberski, MD, Medical Staff
Medicine, Nova Southeastern College of South Florida College of Medicine, Attending, Yale-New Haven Hospital,
Osteopathic Medicine Assistant Professor, Tampa New Haven, Connecticut
Department of Anatomy, University of Asya Mikulinsky, MD, private practice, Peter Taraschi, D0, private practice,
South Florida College of Medicine Miami Palm Bay
Kenneth Botwin, MD, private practice, Winston Parris, MD, private practice, Francisco Torres, MD, private practice,
Florida Spine Institute, Clearwater Clinical Professor of Anesthesiology, Florida Spine Institute, Clearwater
Lawrence Gorfine, MD, private University of South Florida, Tampa,
Andrea Trescot, MD, private practice,
practice, Lake Worth Adjunct Professor of Anesthesiology,
Jacksonville
Vanderbilt University Medical Center,
Gary W. Jay, MD, private practice,
Nashville, Tennessee
Orlando

The Florida Academy of Pain Medicine Treatment of chronic pain due to regarding the validity of an under-utilized
endorses regenerative injection therapy connective tissue diathesis by induc- type-specific treatment for chronic muscu-
and supports its usage for chronic pain tion of collagen chemomodulation though loskeletal pain related to connective
associated with sprained or strained inflammatory, proliferative, and tissue pathology.
ligaments or tendons, repetitive motion regenerative/reparative responses 2. Outline common indications and
disorders, postural pain, and recurrent mediated by multiple growth factors." conditions treated with RIT, as well as
somatic dysfunctions resulting from lax The purpose of this position paper is contraindications thereto.
ligaments. to: 3. Encourage the use of RIT for
Regenerative injection therapy 1. Inform the members of the the treatment of appropriate painful
(RIT), also known as prolotherapy, Florida Academy of Pain Medicine pathology of the connective tissue.
is an interventional technique for the (FAPM) and the medical community at
large

38 June 2002 THE PAIN CLINIC


(For further information, see http://
METHODOLOGY www.hcfa.gov/coverage/8b3.htm.) MECHANISM OF ACTION
The committee recommends consid-
To determine the validity of RIT, The RIT mechanism of action is
eration of RIT as a type-specific
a committee of interventional pain complex and multifaceted. The six
treatment for post-traumatic, degen-
physicians was formed to review currently identified components are:
erative, overuse, and painful condi- 1.
pertinent literature. The committee The mechanical transection of cells
tions of the musculoskeletal system and matrices induced by the
reviewed 78 articles, 9 complete
related to the pathology of the con- needle causes cellular damage
textbooks, and 51 relevant articles
nective tissue. and stimulates an inflammatory
and chapters from additional text-
books. For decades, a small group of cascade. 1,6-1,11,19,102-104
allopathic and osteopathic physicians 2. Compression of cells by the extra-
has been practicing RIT. Pilot, cellular volume of the injected
retrospective, open-face prospective, solution stimulates intracellular
FINDINGS
and double-blind placebo-controlled growth factors .6-1.101-101
From 1937 through 2000, more than studies have clearly indicated the 3. Chemomodulation of collagen
40 publications reported case studies effectiveness of RIT in the treatment through inflammatory prolifer-
and retrospective, prospective, and of chronic musculoskeletal pain ative, regenerative/reparative
animal studies evaluating the results arising from post-traumatic and responses induced by the
of RIT treatment. The studies reported degenerative changes in connective chemical properties of the
the findings of RIT treatment of more tissue such as ligaments, tendons, proliferants and mediated by
than 530,000 patients. Improvement fascia, and intervertebral discs.'-101 cytokines and multiple growth
based on return to work and Clinical and experimental electron factors. 3,6,33,37-39,105-108
restoration of functional and occupa- microscopic studies have proved that 4. Chemoneuromodulation of
tional activities occurred in 48% to newly formed connective tissue has peripheral nociceptors and
82% of the patients. Resolution of biomechanical properties similar to antidromic, orthodromic, sympa-
pain ranged from 0% to 100%. Com- those of normal ligaments and thetic, and axon reflex transmis-
plications included pneumothorax tendons .61,11.16,15 Preliminary results sions. 3,6,43-50
(28), chest tube placement (2), aller- of clinical prospective trials for 5. Modulation of local hemodynam-
gic reaction (24), grand mal seizure chemonucleo-annuloplasty with ics with changes in intraosseous
(1), and aseptic meningitis (1). proliferation-causing substances pressure leading to the reduction of
The findings of the FAPM show significant promise .14,11.64,14 pain. Empirical observations
committee substantially contrast with Conclusions reached in the suggest that a dextrose/lidocaine
the position of Florida Workmen's literature and drawn from extensive combination has a much more
Compensation and the Health Care clinical experience have found RIT prolonged action than lidocaine'
Financing Administration (HCFA) an effective therapy for numerous alone. 6,43-50,109-111
Medicare guidelines, section 35-13, chronic pain conditions. This position 6. A temporary repetitive stabiliza-
which states that "Prolotherapy, joint paper reviews the clinical and patho- tion of the painful hypermobile
sclerotherapy, and ligamentous physiologic aspects of RIT. The joints, induced by the inflam-
injections with sclerosing agentsnot Florida Academy of Pain Medicine matory response to the prolif-
covered... the effectiveness of these endorses RIT when used appropriate- erants, provides a better
therapies has not been verified by ly for the treatment of specific environment for regeneration
scientifically controlled studies." chronic pain entities. and repair of affected ligaments
. 3,4,6,26,27,37-41,91,92,94-97
and tendon S

39 June 2002 THE PAIN CLINIC


owing to failure of cell matrix costovertebral and/or costoster-
PUTATIVE PAIN-GENERATING nal articulations
adaptation to excessive load and
STRUCTURES AFFECTED 7. Osteoarthritis of axial and
BY RIT 5-32,35-69,80-104,112 128 tissue hypoxia with a strong
peripheral joints, spondylosis,
tendency toward chronic pain
spondylolysis, and spondylolis-
2. Ligaments: Intra-articular, and dysfunction .6.1.11.103,105-107 128
thesis
periarticular, capsular 5. Pathologic ligament laxity: A post- 8. Painful cervical, thoracic, lum-
3. Tendons traumatic or congenital condition bar, lumbosacral, and sacroiliac
4. Fascia leading to painful hypermobility of instability secondary to ligament
5. Enthesis: The zone of insertion the axial and laxity
of ligament, tendon, or articular 9. Failed back surgery syndrome
peripheral joints .3,1,11,26-32,35-40
capsule to bone
10. Back pain refractory to radio-
I-12,35-70,75-101,112-126,130,131
6. Intervertebral discs: The outer INDICATIONS
frequency and intradiscal elec-
layers of the annulus represent a Chronic pain from ligaments or trothermal therapy procedures
typical enthesis. tendons secondary to sprains or 11. Tendon, ligament, and synovial
strains joint nociceptive sources. Not
Pain from overuse or occupa- responding to anti-inflammatory
TISSUE PATHOLOGY 2.
tional conditions known as treatment approach
1. Sprain: Ligamentous injury at
repetitive motion disorders, ie, 12. Enhanced results of physical
the fibro-osseous junction or neck and wrist pain in typists therapy and chiropractic/osteo-
intersubstance disruption second- and computer operators, tennis pathic manipulations
ary to sudden or severe twisting of and golfers' elbow, and chronic
a joint with stretching or supraspinatus tendinosis
107-128-130
tearing of ligaments. 3. Chronic postural pain of the SYNDROMES AND
2. Strain: Muscle/tendon injury cervical, thoracic, lumbar, and DIAGNOSTIC ENTITIES
at the fibromuscular or fibro- lumbosacral regions SUCCESSFULLY TREATED
osseous interface. When con- 4. Painful recurrent somatic dys- WITH RIT 2-32,35-70,74-132
cerned with peripheral muscles functions secondary to ligament
and tendons, sprains and strains laxity that improves temporarily 1. Cervicocranial syndrome (cer-
are identified as separate injuries with manipulation. Painful vicogenic headaches, secondary
and in three stage gradations: hypermobility and subluxation at to ligament sprain and laxity,
first-, second- and third-degree given peripheral or spinal articu- atlanto-axial and atlanto-occipi-
sprain or strain." 28-130 lation(s) or mobile segment(s) tal joint sprains, mid-cervical

3. Enthesopathy: A painful degen- accompanied by a restricted zygapophyseal sprains)

erative pathologic process that range of motion at reciprocal 2. Temporomandibular pain and
results in deposition of poorly organized segment(s) muscle dysfunction syndrome
tissue, degeneration 5. Thoracic and lumbar vertebral 3. Barre-Lieou syndrome
and tendinosis at the fibro- compression fractures with a w e d g e 4. Torticollis
osseous interface, and d e f o r m i t y t h a t e x e r t s stress on 5. Cervical segmental dysfunctions
transition toward loss of the posterior ligamento-tendinous 6. Cervicobrachial syndrome
function.
1.6,77,107,128,129 complex (shoulder/neck pain)
Recurrent painful subluxations 7. Hyperextension/hyperflexion
4. Tendinosis/ligamentosis: A focal 6.
of ribs at the costotransverse, injury syndromes
area of degenerative changes

40 JUNE 2002 THE PAIN CLINIC


8. Cervical, thoracic, and lumbar
COMMONLY USED SOLUTIONS
Chronic ankle sprain
zygapophyseal syndromes Instability The most common solutions for injection
9. Cervical, thoracic, and lumbar Laxity of ligaments therapy are dextrose based. Dilutions can
sprain/strain syndrome be made with local anesthetic (eg, I mL
10. Costotransverse joint pain 50% dextrose plus 3 mL 1% lidocaine).
11. Costovertebral arthrosis/ CONTRAINDICATIONS Gradual progression to 25% dextrose
dysfunction solution can be considered .4-8,22
12. Slipping rib syndrome 1. Allergy to anesthetic or prolifer- For intra-articular in jection of
13. Sternoclavicular arthrosis and ant solutions or their ingredients the knee, a 25% dextrose s olution
repetitive sprain such as dextrose, sodium mor- .4
had been used for decades Recently, a
14. Thoracic segmental dysfunction rhuate, or phenol 10% dextrose solution has been
15. Tietze's syndrome 2. Acute non-reduced subluxations investigated and has proved
16. Costochondritis/chondrosis or dislocations effective." The 5% sodium morrhuate
17. Costosternal arthrosis 3. Acute arthritis (septic or post- contains sodium salts of saturated and
18. Xiphoidalgia syndrome traumatic with hemarthrosis) un sa tur at ed fa tt y a c ids o f cod liver
19. Acromioclavicular sprain/ 4. Acute bursitis or tendinitis oil and 2% benzyl alcohol. Note that
arthrosis 5. Capsular pattern shoulder and the benzyl alcohol is chemically
20. Shoulder hand syndrome hip designating acute arthritis similar to phenol and acts as a local
21. Recurrent shoulder dislocations accompanied by tendinitis anesthetic and preservative .4,6,11,77,94
22. Scapulothoracic crepitus 6. Acute gout or rheumatoid Dextrose phenol glycerin solution
23. Iliocostalis friction syndrome arthritis consists of 25% dextrose, 2.5%
24. Iliac crest syndrome 7. Recent onset of a progressive phenol, and 25% glycerin. In all
25. Iliolumbar syndrome neurologic deficit involving the referenced studies, it was diluted
26. Internal lumbar disc disruption segment to be injected, including, with a local anesthetic of the practi-
27. Interspinous pseudoarthrosis but not limited to (severe intractable tioner's choice before injection. Dilution
(Baastrup's disease) cephalgia, unilaterally dilated pupil, reported ratios are 1:1, 1:2, and
2:3.'0,19,20,21,118
28. Lumbar instability bladder dysfunction, bowel The 6% phenol in
29. Lumbar ligament sprain incontinence) glycerin solution was used at donor
30. Spondylolysis 8. Requests for a large quantity of harvest sites of the iliac crests for
31. Sacroiliac joint pain sedation and/or narcotics before neurolytic and proliferative respons-
32. Sacrococcygeal joint pain and after treatment es. 72,101 Other solutions include pumice
33. Gluteal tendinosis 9. Paraspinal neoplastic lesions suspension, tetracycline, a mixture of
34. Trochanteric tendinosis involving the musculature and chondroitin sulfate, glucosamine
35. Myofascial pain syndromes osseous structures sulfate with dextrose, and Plasmo
36. Ehlers-Danlos syndrome 10. Severe exacerbation of pain or Q-U .4,15,25.30-32,64.126
37. Osgood-Schlatter disease lack of improvement after
38. Ankylosing spondylitis infiltration of the putative noci-
CONCLUSIONS
(Marie-Strumpell disease) ceptive structure with a local
39. Failed back syndrome anesthetic 1. Regenerative injection therapy,
40. Fibromyalgia syndrome H. Any acute medical or surgical also known as prolotherapy, is
41. Baker's cyst condition that renders the patient's valuable for the treatment of chronic
42. Foot and/or ankle status unstable painful conditions of the
Sinus tarsi syndrome 12. Infection or neoplasia overlying
Metatarsalgia the area of injection

41 J U N E 2002 THE PAIN CLINIC


The Pain Clinic
A Multidisciplinary Approach to Acute & Chronic Pain Management

locomotive systems. seminars or workshops, apprentice- 45:101-109.


2. Thorough familiarity of normal, ships, or visiting fellowships to safely 10. Barbor R. A treatment for chronic low
and effectively use this treatment. The back pain. Presented at: Fourth Interna-
pathologic, cross-sectional, and
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clinical anatomy, as well as Florida Academy of Pain Medicine
September 6-11. 1964; Paris, France.
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tions is necessary to ensure appropriately for the treatment of specific Related Diseases and Sclerotherapy:
appropriate technique. chronic pain entities. A Guide for Practitioners. Montreal,

3. Current literature supports Canada: Eden Press; 1984.


12. Blaschke J. Conservative management
manipulation under local joint
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35. axial joint pain patterns. Spine. 1994: PAIN MEDICINE
109. Shevelev OA, Sokov EL, Klepikov 19:1125-1131.
121. Dreyfuss P, Tibiletti C, Dreyer SJ. 3807 NW 53rd Terrace
RV. Interosseous receptor system as the
Thoracic zygapophyseal joint pain Gainesville, FL 32606
modulator of trigeminal afferent reactions.
(352) 372-9360
Pain Clin. 2000;34:715-721. patterns: a study in normal volunteers.
110. Sokov E, Mustafa A. Are herniated Spine. 1994; 19:807-811. Become a member of the Florida
disks the main cause of low back pain. 122. Dreyfuss P. Differential diagnosis of Academy of Pain Medicine today to take
thoracic pain and diagnostic/therapeutic advantage of a broad range of
Pain Clin. 2000;74:715-721.
membership benefits, including:
111. Zoppi M, Beneforti E. From intra- injection techniques. ISIS Newsletter Discounted registration at educational
osseous pain syndrome to osteoarthritis. 1997:10-29. conferences, important legal and
Worldwide Pain Conference. Pain and 123. Dreyfuss P, Michaelsen M, Home regulatory updates, advocacy on
Neuromodulation: The New Millennium. M. MUJA: manipulation under joint billing and reimbursement issues, and the
Proceedings of the 9th World Congress. anesthesia/analgesia: a treatment ap- opportunity to network with colleagues
from a wide variety of specialties. For
The Pain Clinic. July 2000; San Francisco, proach for recalcitrant low back pain of
more information, contact the FAPM
Calif. synovial joint origin. J Manipulative ve headquarters at (352) 372-9360.
112. Agur A, Lee MJ. Grants Atlas of Physiol Ther October 1995;18:537-546.
Anatomy. 9th ed. Baltimore, Md. 124. Dussault R, Kaplan PA. Facet joint
2001-2002 BOARD OF DIRECTORS
Williams & Wilkins; 1991. injection: diagnosis and therapy. Appl
113. Aprill C, Dwyer A, Bogduk N. Radiol. June 1994:35-39.
Cervical zygapophyseal joint pain patterns 125. Dwyer A, Aprill C, Bogduk N. President - Andrea M. Trescot, MD
Cervical zygapophyseal joint pain patterns President-elect - Gary W. Jay, MD
11: a clinical evaluation. Spine.
Secretary - Winston Parris, MD
1990;15:458-461. I: a study in normal volunteers. Spine. Vice President -
114. Ashton IK, Ashton BA, Gibson SJ, 1990;15:453-457. Francisco M. Torres, MD
Polak JM, Jaffray DC, Eisenstein SM. 126. Freemont A. Nerve ingrowth into Treasurer - Kenneth P. Botwin, MD
Morphological basis for back pain: the diseased intervertebral disc in chronic Legislative Committee Chair -
back pain. Lancet. 1997;350:178-181. Sanford Z. Pollack, DO
demonstration of nerve fibers and neu-
127. Hunt WE, Baird WC. Complications Membership Committee -
ropeptides in the lumbar facet joint James J. Worden, MD
capsule but not in ligamentum flavum. J following injection of sclerosing agent to Past President -
Orthop Res. 1992;10:72-77. precipitate fibro-osseous proliferation. J James B. Boorstin, MD
115. Barnsley L, Lord SM, Wallis BJ, Neurourg. 1981;18:461-465. Immediate Past President -
Bogduk N. Lack of effect of intra-articular 128. Jozsa LG, Kannus P. Human Felix S. Linetsky, MD
corticosteroids for chronic pain Tendons: Anatomy, Physiology and

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