PROLOTHERAPY for Musculoskeletal PAIN 2007
PROLOTHERAPY for Musculoskeletal PAIN
A primer for pain management physicians on the mechanism of action and indications for use.
By Donna Alderman, DO
P
rolotherapy is a method of injection treatment designed to stimulate healing.1 This treatment is used for musculoskeletal pain which has gone on longer than 8 weeks such as low back and neck pain, chronic sprains and/or strains, whiplash injuries, tennis and golfer’s elbow, knee, ankle, shoulder or other joint pain, chronic tendonitis/tendonosis, and musculoskeletal pain related to os-teoarthritis. Prolotherapy works by rais-ing growth factor levels or effectiveness to promote tissue repair or growth.2 It can be used years after the initial pain or prob-lem began, as long as the patient is healthy. Because prolotherapy works to repair weak and painful joint areas, it is a long term solution rather than a pallia-tive measure such as drugs, and should be considered prior to the use of long term drugs or surgery in appropriate patients.
In the April 2005 issue of the Mayo Clin-ic Health Letter, the authors wrote: “In the case of chronic ligament or tendon pain that hasn’t responded to more conserva-tive treatments such as prescribed exer-cise and physical therapy, prolotherapy may be helpful.”3 Prolotherapy has been used in the U.S. for musculoskeletal pain since the 1930’s, is endorsed by former U.S. Surgeon General, C. Everett Koop,4 and has even made its way into the pro-fessional sports world.5 In a 2000 issue of The Physician and Sportsmedicine, “Are Your Patients Asking About Prolotherapy?” the article starts:
“Prolotherapy, considered an alterna-tive therapy, is quietly establishing itself in mainstream medicine because of its al-most irresistible draw for both physicians and patients: nonsurgical treatment for musculoskeletal conditions.”
The article states that as many as 450,000 Americans had undergone pro-lotherapy and that some of the patients reporting benefits from prolotherapy were physicians themselves.6 Yet, many physicians have still not heard of or do not know much about prolotherapy.
The purpose of this article is to give the pain management physician an introduc-tion to prolotherapy, how and why it works, and indications for its use.
Background and History
Prolotherapy is based on the premise that chronic musculoskeletal pain is due to in-adequate repair of fibrous connective tis-sue, resulting in ligament and tendon weakness or relaxation (laxity),1 also known as connective tissue insufficiency.7 When the connective tissue is weak, there is insufficient tensile strength or tight-ness.8 Load-bearing then stimulates pain mechanoreceptors.7 As long as connective tissue remains functionally insufficient, these pain mechanoreceptors continue to fire with use.9 If laxity or tensile strength deficit is not corrected sufficiently to stop pain mechanoreceptor stimulation, chronic sprain or strain results.2 This is the problem that prolotherapy addresses: stimulating growth factors to resume or initiate a connective tissue repair se-quence, repairing and strengthening lax ligaments and/or tendons, and ultimate-ly reducing or eliminating pain.
Historically, the use of prolotherapy dates back to Hippocrates who treated dis-located shoulders of soldiers on the bat-tlefields with red-hot needle cautery to sta-bilize the joint. From 1835 to 1935, injec-tion of sclerosing type agents was used for hernias to proliferate new fibrous tissue. It was during the 1930’s that George Hack-ett, MD, a general surgeon, made the ob-servation — while doing hernia surgery on patients previously treated with prolifer-ant type therapy — that “Injections made (usually in error) at the junction of liga-
Practical PAIN MANAGEMENT, January/February 2007
c2007 PPM Communications, Inc. Reprinted with permission.
FIGURE 1. Photograph of rabbit tendons at nine and 12 months after three injections of proliferating solution into the right tendons. From Hauser, “Prolo Your Pain Away,” Second Edition. 2004. Beulah Land Press, Oak Park, IL. Used with permission.
FIGURE 2. Pain referral patterns from lumbosacral and pelvic joint lig-aments. From Hauser, “Prolo Your Pain Away,” Second Edition. 2004. Beulah Land Press. Oak Park, IL. Used with permission.
Prolotherapy F or Musculoskeletal P ain
1.
Appropriate medical problem.
2.
Desire for recovery.
3.
No underlying medical conditions which would signifi-cantly interfere with healing.
4.
Ability and willingness to follow instructions.
5.
Willingness to report progress.
6.
Willingness to receive painful injections in an effort to recover from injury.”1
These criteria are still true today. The patient must present with an appropriate musculoskeletal problem. The patient needs to have a desire to get better, no known illness which could prevent healing, willingness to follow instructions and to under-go injections. Examples of illnesses which would prevent heal-ing include autoimmune or immunodeficiency disorders, or ac-tive cancers. Also, the patient should not be taking drugs which lower the immune system such as systemic corticosteroids or im-mune suppressants. And, because prolotherapy works to stimu-late inflammation, patients should not be taking anti-inflamma-tory medication during treatment. In fact, as mentioned above and although frequently prescribed for musculoskeletal pain, use of NSAIDs may interfere with healing and is questionable in treatment of musculoskeletal injuries.17
Age is not a factor as long as the individual is healthy. It also does not matter how long the person has been in pain, or how long ago they injured themselves as long as the person is in good, general health.
MRIs May Be Misleading in Diagnosing Musculoskeletal Pain
When deciding what patients are candidates for prolotherapy, do not be mislead by the MRI or use the MRI for diagnosis alone. As many pain practitioners know, an MRI may show noth-ing wrong and yet the patient is still in pain. And, because MRI’s may also show abnormalities not related to the patient’s current pain complaint, MRI findings should always be correlated to the individual patient. Many studies have documented the fact that abnormal MRI findings exist in large groups of pain-free indi-viduals.65-71 A study published in the New England Journal of Medicine showed that out of 98 pain-free people, 64% had ab-normal back scans.72 Many other studies have also shown abnor-mal neck MRI scans in asymptomatic subjects,73-75 and the find-ing of asymptomatic changes in knee joints during surgery is not uncommon.76,77 One study looked at the value of MRI’s in the treatment of knee injuries and concluded: “Overall, mag-netic resonance imaging diagnoses added little guidance to pa-tient management and at times provided spurious [false] infor-mation.” So, do not use an MRI alone to determine a treatment course. The MRI should be used in combination with a history of the complaint, precipitating factors or trauma, and a physi-cal exam.
Indications
Prolotherapy has been used to successfully treat a large variety of musculoskeletal syndromes, including cervical, thoracic and lumbar pain syndromes, patients diagnosed with “disc disease,” mechanical low back pain, plantar fascitits, foot or ankle pain, chronic rotator cuff or bicipital tendonitis/tendonsis, lateral and medial epicondylitis, TMJ dysfunction, musculoskeletal pain re-lated to osteoarthritis, and even finger or toe joint pain includ-ing “turf toe.” It is important to rule out a systemic or non-mus-culoskeletal origin for the complaints, confirm no underlying illness which would prevent healing, and also to ensure there are no contraindications to treatment (see section below).
The Florida Academy of Pain Management laid out indica-tions for prolotherapy (Regenerative Injection Therapy or RIT) based on their review of the literature:
1.
Chronic pain from ligaments or tendons secondary to sprains or strains.
2.
Pain from overuse or occupational conditions known as “Repetitive Motion Disorders,” i.e. neck and wrist pain in typists and computer operators, “tennis” and “golfers” elbows and chronic supraspinatous tendinosis.
3.
Chronic postural pain of the cervical, thoracic, lumbar and lumbosacral regions.
4.
Painful recurrent somatic dysfunctions secondary to liga-ment laxity that improves temporarily with manipulation. Painful hypermobility and subluxation at given peripher-al or spinal articulation(s) or mobile segment(s) accompa-nied by a restricted range of motion at reciprocal seg-ment(s).
5.
Thoraic and lumbar vertebral compression fractures with a wedge deformity that exert additional stress on the pos-terior ligamento-tendinous complex.
6.
Recurrent painful subluxations of ribs at the costotrans-verse, costovertebral and/or costosternal articulations.
7.
Osteoarthritis of axial and peripheral joints, spondylosis and spondylothesis.
8.
Painful cervical, thoracic, lumbar, lumbosacral and
.sacroiliac instability secondary to ligament laxity.
9.
Intolerance to NSAIDs, steroids or opiates. RIT (pro-
Practical PAIN MANAGEMENT, January/February 2007
c2007 PPM Communications, Inc. Reprinted with permission.
Prolotherapy F or Musculoskeletal P ain
lotherapy) may be the treatment of choice if the patient fails to improve after physical therapy, chiropractic or osteopathic manip-ulations, steroid injections or radiofrequency denervation or sur-gical interventions in the afore-mentioned conditions, or if such modalities are contraindicated.48
Contraindications
Active infection or cancer is a contraindi-cation to treatment, as is any underlying illness which could interfere with healing. Immunodeficiency conditions, acute gout or rheumatoid arthritis, complete rupture of a tendon or ligament, non-reduced dis-locations, or severe, unstable spondy-lolithesis are also contraindications. Other contraindications are allergy to any of the ingredients in the prolotherapy for-mula or unwillingness to experience pos-sible after-treatment discomfort. Patients should understand the course of the pro-lotherapy treatment and be participants in their treatment plan.
Relative contraindications include cur-rent and long term use of high doses of narcotics as these medications can lower the immune response. Current use of sys-temic corticosteroids or NSAIDS are also relative contraindications as these are counterproductive to the inflammatory process. Other relative contraindications include central canal spinal stenosis and severe degenerative hip osteoarthritis with loss of range of motion.
Risks
While the most common risk is soreness after treatment, prolotherapy is a med-ical procedure and, as such, there are risks. While prolotherapy is a low risk procedure, any possible risk should al-ways be fully discussed with a patient prior to treatment and a medical consent signed. Typical risks include bruising around the injected area and the risk of being in more pain — typically for one or two days after treatment — because of the intended inflammation. However, there is a risk that the pain after treat-ment will continue longer than expected. Other more rare risks include infection, headache, nerve irritation, allergy, punc-ture of an organ (such as the lungs) if in-jecting around that region, epidural puncture, or other unexpected risk. There is also the risk that the procedure will not work.
Typical Treatment Course
Treatment intervals are spaced according to how that individual heals. On average, the treatment interval is usually 3 to 4 weeks between treatments. In some peo-ple it is shorter, in others it is longer. The average number of treatments for any given area is usually between 4 and 6 total treatments, each treatment involving multiple injections to a particular area. Improvement is sometimes noticed after the initial treatment, however it is more often noticed by the second or third treat-ment. Some individuals require more than 6 treatments, and, in some cases, less treatments are needed. Individuals with hypermobility often take longer.
How To Get Training In Prolotherapy
Before attempting to use prolotherapy in your practice, it is important to get a solid understanding of prolotherapy basics, as well as approved hands-on and preceptor-ship training in prolotherapy techniques. Do not attempt to do prolotherapy based on this article or any other article or pub-lication alone. Even if you are adept at in-jection techniques, you should get special-ized training in the technique of pro-lotherapy and hands-on training experi-ence. While there is no fellowship in pro-lotherapy available at this time, there are courses given through various associations including the American Academy of Os-teopathy; University of Wisconsin School of Medicine — Continuing Medical Edu-cation Department; American Academy of Musculo-Skeletal Medicine; American College of Osteopathic Sclerotherapeutic Pain Management; and the American As-sociation of Orthopedic Medicine. It is recommended that you do more than one course. There are also some physicians of-fering preceptor training through their of-fices. It is recommended that you read the Hackett/Hemwall/Montgomery primer on the subject (see Reference 1) as well as other books on prolotherapy by Ross Hauser, MD, available at www.beulahland press.com.
If your practice is too busy to learn pro-lotherapy, at least your knowledge and understanding of the technique will allow you to refer appropriate patients for treat-ment. Since prolotherapy is a treatment modality that provides a long term solu-tion rather than just palliation, it should be considered in appropriate patients prior to resorting to long term narcotic therapy or surgical intervention. ■
Donna Alderman, DO is a graduate of West-ern University of Health Sciences, College of Osteopathic Medicine of the Pacific, in Pomona, California, with an undergraduate degree from Cornell University in Ithaca, NY. She has extensive training in prolotherapy and has been using prolotherapy in her practice for ten years. She is the author of “Prolotherapy: Freeing Yourself From Chronic Pain,” an easy to read primer on the basics of prolotherapy for the lay person, pending publication in 2007. Dr. Alderman is the Medical Director of Hemwall Family Medical Centers in Califor-nia and can be reached through her website www.prolotherapy.com.
A primer for pain management physicians on the mechanism of action and indications for use.
By Donna Alderman, DO
P
rolotherapy is a method of injection treatment designed to stimulate healing.1 This treatment is used for musculoskeletal pain which has gone on longer than 8 weeks such as low back and neck pain, chronic sprains and/or strains, whiplash injuries, tennis and golfer’s elbow, knee, ankle, shoulder or other joint pain, chronic tendonitis/tendonosis, and musculoskeletal pain related to os-teoarthritis. Prolotherapy works by rais-ing growth factor levels or effectiveness to promote tissue repair or growth.2 It can be used years after the initial pain or prob-lem began, as long as the patient is healthy. Because prolotherapy works to repair weak and painful joint areas, it is a long term solution rather than a pallia-tive measure such as drugs, and should be considered prior to the use of long term drugs or surgery in appropriate patients.
In the April 2005 issue of the Mayo Clin-ic Health Letter, the authors wrote: “In the case of chronic ligament or tendon pain that hasn’t responded to more conserva-tive treatments such as prescribed exer-cise and physical therapy, prolotherapy may be helpful.”3 Prolotherapy has been used in the U.S. for musculoskeletal pain since the 1930’s, is endorsed by former U.S. Surgeon General, C. Everett Koop,4 and has even made its way into the pro-fessional sports world.5 In a 2000 issue of The Physician and Sportsmedicine, “Are Your Patients Asking About Prolotherapy?” the article starts:
“Prolotherapy, considered an alterna-tive therapy, is quietly establishing itself in mainstream medicine because of its al-most irresistible draw for both physicians and patients: nonsurgical treatment for musculoskeletal conditions.”
The article states that as many as 450,000 Americans had undergone pro-lotherapy and that some of the patients reporting benefits from prolotherapy were physicians themselves.6 Yet, many physicians have still not heard of or do not know much about prolotherapy.
The purpose of this article is to give the pain management physician an introduc-tion to prolotherapy, how and why it works, and indications for its use.
Background and History
Prolotherapy is based on the premise that chronic musculoskeletal pain is due to in-adequate repair of fibrous connective tis-sue, resulting in ligament and tendon weakness or relaxation (laxity),1 also known as connective tissue insufficiency.7 When the connective tissue is weak, there is insufficient tensile strength or tight-ness.8 Load-bearing then stimulates pain mechanoreceptors.7 As long as connective tissue remains functionally insufficient, these pain mechanoreceptors continue to fire with use.9 If laxity or tensile strength deficit is not corrected sufficiently to stop pain mechanoreceptor stimulation, chronic sprain or strain results.2 This is the problem that prolotherapy addresses: stimulating growth factors to resume or initiate a connective tissue repair se-quence, repairing and strengthening lax ligaments and/or tendons, and ultimate-ly reducing or eliminating pain.
Historically, the use of prolotherapy dates back to Hippocrates who treated dis-located shoulders of soldiers on the bat-tlefields with red-hot needle cautery to sta-bilize the joint. From 1835 to 1935, injec-tion of sclerosing type agents was used for hernias to proliferate new fibrous tissue. It was during the 1930’s that George Hack-ett, MD, a general surgeon, made the ob-servation — while doing hernia surgery on patients previously treated with prolifer-ant type therapy — that “Injections made (usually in error) at the junction of liga-
Practical PAIN MANAGEMENT, January/February 2007
c2007 PPM Communications, Inc. Reprinted with permission.
FIGURE 1. Photograph of rabbit tendons at nine and 12 months after three injections of proliferating solution into the right tendons. From Hauser, “Prolo Your Pain Away,” Second Edition. 2004. Beulah Land Press, Oak Park, IL. Used with permission.
FIGURE 2. Pain referral patterns from lumbosacral and pelvic joint lig-aments. From Hauser, “Prolo Your Pain Away,” Second Edition. 2004. Beulah Land Press. Oak Park, IL. Used with permission.
Prolotherapy F or Musculoskeletal P ain
1.
Appropriate medical problem.
2.
Desire for recovery.
3.
No underlying medical conditions which would signifi-cantly interfere with healing.
4.
Ability and willingness to follow instructions.
5.
Willingness to report progress.
6.
Willingness to receive painful injections in an effort to recover from injury.”1
These criteria are still true today. The patient must present with an appropriate musculoskeletal problem. The patient needs to have a desire to get better, no known illness which could prevent healing, willingness to follow instructions and to under-go injections. Examples of illnesses which would prevent heal-ing include autoimmune or immunodeficiency disorders, or ac-tive cancers. Also, the patient should not be taking drugs which lower the immune system such as systemic corticosteroids or im-mune suppressants. And, because prolotherapy works to stimu-late inflammation, patients should not be taking anti-inflamma-tory medication during treatment. In fact, as mentioned above and although frequently prescribed for musculoskeletal pain, use of NSAIDs may interfere with healing and is questionable in treatment of musculoskeletal injuries.17
Age is not a factor as long as the individual is healthy. It also does not matter how long the person has been in pain, or how long ago they injured themselves as long as the person is in good, general health.
MRIs May Be Misleading in Diagnosing Musculoskeletal Pain
When deciding what patients are candidates for prolotherapy, do not be mislead by the MRI or use the MRI for diagnosis alone. As many pain practitioners know, an MRI may show noth-ing wrong and yet the patient is still in pain. And, because MRI’s may also show abnormalities not related to the patient’s current pain complaint, MRI findings should always be correlated to the individual patient. Many studies have documented the fact that abnormal MRI findings exist in large groups of pain-free indi-viduals.65-71 A study published in the New England Journal of Medicine showed that out of 98 pain-free people, 64% had ab-normal back scans.72 Many other studies have also shown abnor-mal neck MRI scans in asymptomatic subjects,73-75 and the find-ing of asymptomatic changes in knee joints during surgery is not uncommon.76,77 One study looked at the value of MRI’s in the treatment of knee injuries and concluded: “Overall, mag-netic resonance imaging diagnoses added little guidance to pa-tient management and at times provided spurious [false] infor-mation.” So, do not use an MRI alone to determine a treatment course. The MRI should be used in combination with a history of the complaint, precipitating factors or trauma, and a physi-cal exam.
Indications
Prolotherapy has been used to successfully treat a large variety of musculoskeletal syndromes, including cervical, thoracic and lumbar pain syndromes, patients diagnosed with “disc disease,” mechanical low back pain, plantar fascitits, foot or ankle pain, chronic rotator cuff or bicipital tendonitis/tendonsis, lateral and medial epicondylitis, TMJ dysfunction, musculoskeletal pain re-lated to osteoarthritis, and even finger or toe joint pain includ-ing “turf toe.” It is important to rule out a systemic or non-mus-culoskeletal origin for the complaints, confirm no underlying illness which would prevent healing, and also to ensure there are no contraindications to treatment (see section below).
The Florida Academy of Pain Management laid out indica-tions for prolotherapy (Regenerative Injection Therapy or RIT) based on their review of the literature:
1.
Chronic pain from ligaments or tendons secondary to sprains or strains.
2.
Pain from overuse or occupational conditions known as “Repetitive Motion Disorders,” i.e. neck and wrist pain in typists and computer operators, “tennis” and “golfers” elbows and chronic supraspinatous tendinosis.
3.
Chronic postural pain of the cervical, thoracic, lumbar and lumbosacral regions.
4.
Painful recurrent somatic dysfunctions secondary to liga-ment laxity that improves temporarily with manipulation. Painful hypermobility and subluxation at given peripher-al or spinal articulation(s) or mobile segment(s) accompa-nied by a restricted range of motion at reciprocal seg-ment(s).
5.
Thoraic and lumbar vertebral compression fractures with a wedge deformity that exert additional stress on the pos-terior ligamento-tendinous complex.
6.
Recurrent painful subluxations of ribs at the costotrans-verse, costovertebral and/or costosternal articulations.
7.
Osteoarthritis of axial and peripheral joints, spondylosis and spondylothesis.
8.
Painful cervical, thoracic, lumbar, lumbosacral and
.sacroiliac instability secondary to ligament laxity.
9.
Intolerance to NSAIDs, steroids or opiates. RIT (pro-
Practical PAIN MANAGEMENT, January/February 2007
c2007 PPM Communications, Inc. Reprinted with permission.
Prolotherapy F or Musculoskeletal P ain
lotherapy) may be the treatment of choice if the patient fails to improve after physical therapy, chiropractic or osteopathic manip-ulations, steroid injections or radiofrequency denervation or sur-gical interventions in the afore-mentioned conditions, or if such modalities are contraindicated.48
Contraindications
Active infection or cancer is a contraindi-cation to treatment, as is any underlying illness which could interfere with healing. Immunodeficiency conditions, acute gout or rheumatoid arthritis, complete rupture of a tendon or ligament, non-reduced dis-locations, or severe, unstable spondy-lolithesis are also contraindications. Other contraindications are allergy to any of the ingredients in the prolotherapy for-mula or unwillingness to experience pos-sible after-treatment discomfort. Patients should understand the course of the pro-lotherapy treatment and be participants in their treatment plan.
Relative contraindications include cur-rent and long term use of high doses of narcotics as these medications can lower the immune response. Current use of sys-temic corticosteroids or NSAIDS are also relative contraindications as these are counterproductive to the inflammatory process. Other relative contraindications include central canal spinal stenosis and severe degenerative hip osteoarthritis with loss of range of motion.
Risks
While the most common risk is soreness after treatment, prolotherapy is a med-ical procedure and, as such, there are risks. While prolotherapy is a low risk procedure, any possible risk should al-ways be fully discussed with a patient prior to treatment and a medical consent signed. Typical risks include bruising around the injected area and the risk of being in more pain — typically for one or two days after treatment — because of the intended inflammation. However, there is a risk that the pain after treat-ment will continue longer than expected. Other more rare risks include infection, headache, nerve irritation, allergy, punc-ture of an organ (such as the lungs) if in-jecting around that region, epidural puncture, or other unexpected risk. There is also the risk that the procedure will not work.
Typical Treatment Course
Treatment intervals are spaced according to how that individual heals. On average, the treatment interval is usually 3 to 4 weeks between treatments. In some peo-ple it is shorter, in others it is longer. The average number of treatments for any given area is usually between 4 and 6 total treatments, each treatment involving multiple injections to a particular area. Improvement is sometimes noticed after the initial treatment, however it is more often noticed by the second or third treat-ment. Some individuals require more than 6 treatments, and, in some cases, less treatments are needed. Individuals with hypermobility often take longer.
How To Get Training In Prolotherapy
Before attempting to use prolotherapy in your practice, it is important to get a solid understanding of prolotherapy basics, as well as approved hands-on and preceptor-ship training in prolotherapy techniques. Do not attempt to do prolotherapy based on this article or any other article or pub-lication alone. Even if you are adept at in-jection techniques, you should get special-ized training in the technique of pro-lotherapy and hands-on training experi-ence. While there is no fellowship in pro-lotherapy available at this time, there are courses given through various associations including the American Academy of Os-teopathy; University of Wisconsin School of Medicine — Continuing Medical Edu-cation Department; American Academy of Musculo-Skeletal Medicine; American College of Osteopathic Sclerotherapeutic Pain Management; and the American As-sociation of Orthopedic Medicine. It is recommended that you do more than one course. There are also some physicians of-fering preceptor training through their of-fices. It is recommended that you read the Hackett/Hemwall/Montgomery primer on the subject (see Reference 1) as well as other books on prolotherapy by Ross Hauser, MD, available at www.beulahland press.com.
If your practice is too busy to learn pro-lotherapy, at least your knowledge and understanding of the technique will allow you to refer appropriate patients for treat-ment. Since prolotherapy is a treatment modality that provides a long term solu-tion rather than just palliation, it should be considered in appropriate patients prior to resorting to long term narcotic therapy or surgical intervention. ■
Donna Alderman, DO is a graduate of West-ern University of Health Sciences, College of Osteopathic Medicine of the Pacific, in Pomona, California, with an undergraduate degree from Cornell University in Ithaca, NY. She has extensive training in prolotherapy and has been using prolotherapy in her practice for ten years. She is the author of “Prolotherapy: Freeing Yourself From Chronic Pain,” an easy to read primer on the basics of prolotherapy for the lay person, pending publication in 2007. Dr. Alderman is the Medical Director of Hemwall Family Medical Centers in Califor-nia and can be reached through her website www.prolotherapy.com.
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