Prolotherapy Provides Results
Richard Gracer, M.D.
Prolotherapy is an effective way to treat ligament and tendon laxity-the actual cause of the most musculoskeletal pain.
With age, the water content in our joints and connective tissues decreases and the cartilage gets brittle and shrinks. There is less synovial fluid to bring nutrition. This combination of circumstances causes our joints to loosen, and at the same time they become increasingly vulnerable to injury. The greatest stresses are at the attachments of the ligaments and tendons to bone at the fibro-osseous junction. As the joints lose their resilience and range of motion, other areas of the body have to take more and unusual stresses to make up for these deficiencies. This can result in injury and pain in areas remote from the direct source. Direct trauma, such as a sprained knee or ankle, can start this process prematurely, bringing early pain and disability. This results from incompletely healed structures that stay lax and cause unusual and increased stresses on nearby and even distant structures.
Ligaments do not always heal completely because they do not have a good blood supply, so ligament pain can persist indefinitely from the painful scar, as well as from the physical geometric strains of laxity. (A good example is to think of a door with loose hinges. The doorframe as well as the hinges themselves are stressed and sustain damage.)
Pain is felt in distant body parts, not only because of these physical strains, but also from what is called "referred sclerotomal" pain and tenderness. This referred pain and tenderness from ligaments, joints, muscles and tendons is felt in distant areas of the body in much the same way that a lumbar nerve root causes "sciatica" or a heart attack can give left arm or jaw pain. Because of this confusion, the pain origin is often misdiagnosed, and the ligamentous pain source goes unrecognized and untreated.1, 2.
After injury, physicians often try to limit inflammation, swelling, and pain by prescribing medications, such as ibuprofen or naproxen. Once you realize that the same mechanism that heals ligaments causes the swelling, it makes sense that to limit one reaction can also halt or inhibit the other. After the immediate inflammation ceases, there can be residual laxity that can stay painful and limiting indefinitely. In addition, the muscles that surround lax joints must work overtime to stabilize them. This, along with the painful sensations from the ligaments themselves, causes muscle spasm and trigger points to form, manifesting as myofascial pain syndrome as described by Janet Travell.3
These painful muscle areas can also cause referred pain, often confusing both patients and their physicians. While "trigger points" are true entities, and treatment of these muscle problems will decrease pain temporarily, the real cause is not eliminated. This must be done by tightening and desensitizing the supporting ligaments using prolotherapy. This stops the pain at its root cause. As the ligaments tighten up, the muscles can relax and the trigger points will disappear.
Prolotherapy works by stimulating the body's own healing system. Today, several injection solutions are employed, using various methods to stimulate the mild inflammatory response that "turns on" the healing process. 4 Once started, use of stretching and range of motion exercises makes sure that the ligaments that are produced are in the correct alignment and that there are no cross fibers that can cause limitation of motion and pain. These new ligaments and tendon should not be confused with scar tissue, which is a chaotic matrix of collagen fibers. The ligaments and tendons produced after prolotherapy appear much the same as normal tissues, except that they are thicker, stronger, and contain fibers of varying thickness, testifying to the new and ongoing creation of tissue. 5,6,7,8
In 1980, I was first introduced to prolotherapy when I studied orthopedic medicine in Great Britain. It was used to stabilize low back ligaments in patients with recurrent back problems. I started using it in my Northern California medical practice and found the results excellent. I soon started teaching others about the treatment. Over the years research has shown its effectiveness and demonstrated how it works. The following are just a few examples of the research that has been performed. First, let's see how well prolotherapy works.
George S. Hackett, M.D.
George S. Hackett was one of the pioneers of prolotherapy. In his book, Ligament and Tendon Relaxation Treated by Prolotherapy, published in 1958, he described the symptoms and treatment of tendon and ligament relaxation with prolotherapy. He also presented the results of his treatment of 656 patients:
- Patient age range: 15 to 88 years old
- Duration of pain prior to prolotherapy: 3 months to 65 years
- Average duration: 4 Ѕ years
- Duration of study: 19 years
- Number of injections given: 18,000
Dr. Hackett believed that he could cure over 90 percent of his patients using the techniques that he developed and described in his book. He used Synaslol, a fatty acid and direct activator of the inflammatory process. This substance is no longer used, as later proponents of Hackett found that simple dextrose diluted with the local anesthetic lidocaine was almost as effective in most cases and eliminated many of the risks inherent with injecting very irritating substances into sensitive areas.
In 1955 Dr. Hackett studied 146 consecutive cases of low back pain over a two-month period. He diagnosed ligamentous laxity in 94 percent of them. In 1956, Dr. Hackett diagnosed 97 percent of 124 consecutive cases of low back pain as having ligamentous laxity. In 75 percent the sacroiliac ligaments were involve and the lumbosacral ligaments were involved in 54 percent. His overall cure rate for these groups was 80 percent, even though 50 percent of them had had pervious low back surgery.
Dr. Hackett also found that injected tendons increased in diameter by 40 percent after prolotherapy and that microscopic examination of the treated structures showed no destruction of nerves and blood vessels; there was no scarring. 5
Gustav A. Hemwall, M.D.
Gustav. A. Hemwall. M.D. is one of the most famous of Hackett's' students. He has taught and studied prolotherapy worldwide for over 30 years. Of the over 10,000 patients that he has treated, he has studied 8000.
In 1974 Dr. Hemwall presented the results of 2007 prolotherapy patients. The results were:
- 1871 patients completed treatment
- 6000 prolotherapy treatments were given
- 1399 (75.5percent) patients reported complete recovery or cure
- 413 (24.3 percent) reported general improvement
- 25 (0.2 percent) patients showed no improvement
- 170 patients were lost to follow up
This survey demonstrates one of the highest success rates of any study of prolotherapy. Most studies show from 75 to over 90 percent successful results. It's apparent that prolotherapy provides a very high success rate even in patients with longstanding problems that had been resistant to many other treatments.
Robert Klein, MD, Thomas Dorman, MD, and Bjorn Eek, MD, and Milne Ongley, MD
In 1987, these physicians performed the first double blind controlled study of prolotherapy, which was published in the prestigious medical journal Lancet. 9 They solicited patients with back pain from the patient list of the Sansum clinic in Santa Barbara, California. With over 10,000 mailed inquiries, and using a strict set of criteria (such as no litigation, longstanding pain, no severe medical illnesses, and a diagnosis of ligamentous back pain) they narrowed the field to 81 people.
One half of this group received prolotherapy injections with a solution of dextrose, phenol, lidocaine, and glycerin, while the others were injected with saline. The average length of time of symptoms was 8.98 years in the treatment group and 10.72 years in the placebo group. Both groups received one forceful spinal manipulation before injection. The assessors did not know which treatment any of the participants had received. The results showed a large difference in the two groups, with the prolotherapy group showing a marked decrease in subjective pain as compared to the saline group that was statistically significant. (p<0.001 at 6 months).
The number of patients who were free of disability after 6 months was 4 in the saline and 15 in the treatment group. The fact that the placebo group improved, although much less than the treatment group, demonstrates that saline injection has some proliferant effects. An interesting fact about this study is that the researchers wanted to continue the observations for a total of one year, but they had promised the placebo group that they would be treated with the proliferant if they still had pain. There was great pressure on these physicians to end the study at six months. I understand that they successfully treated the pain of a large number of the placebo group patients after the study was completed.
A later 1993 double blind study by Drs. Klein and Eek showed similar results. 10 In this experiment, all patients received either a CT scan or an MRI of the lumbar spine. The results showed that there was no difference in the initial symptoms or the experimental results between those with significant disc bulges on the scans and those without them. This demonstrates that disc bulges are not the cause of most back pain and that the ligaments should be treated if the patient history and examination indicates that ligament laxity is the source of the pain.
Drs. Klein, Dorman, Ongley, and Eek also studied knee ligament instability in a 1988 study in Manual Medicine.11 They measured the laxity of knee ligaments using a known and widely used computerized mechanism. Only five patients completed the full study because of logistical problems. All five of these patients reported marked decrease in knee pain. The measurements also showed significant decrease in joint laxity in all of the axes measured.
In 1993, Dr. Dorman published a survey of prolotherapy injections performed by 95 respondents. 12 These physicians reported on a total of 494,845 patients. Of these 343,897 were treated for low back, 98,430 for other areas of the spine, and 26.85 percent also reported non-spine peripheral joint injections. The cumulative years in practice of all the practitioners in the survey were 1092. Only 66 minor complications were reported. These included 24 reports of allergic reactions and 29 cases of pneumothorax (a condition caused by a needle placed into the lung cavity). All of these resolved without serious problems. There were also 14 reports of major complications, defined as the patient needing hospitalization or having transient or permanent nerve damage.
It's amazing that of almost 500,000 patients treated by these physicians that there were so few problems. Although no outcomes were solicited as part of this study, the overall success of prolotherapy is from 75 to over 90 percent, including patients who have had surgery and who have had pain for over 50 years! The chance of a good outcome increases depending upon the exact clinical situation, but I can often be over 90 percent sure that my patient will improve with prolotherapy treatment.
Robert Schwartz, MD
Robert Schwartz, MD did a retrospective study of 43 patients with chronic low back pain who had been unresponsive to other treatments, including surgery. 13 He gave prolotherapy treatment to the sacroiliac joint area over six weeks. At end of that time, 93 percent of the participants reported significant improvement. Only three of the patients reported no improvement.
Richard I. Gracer, MD
During 1986, while my colleagues and friends, Drs. Klein, Eek, Ongley and Dorman were collecting the data for their landmark Lancet paper; I performed my own research on 57 consecutive patients with severe ligamentous back pain. 14 I personally treated them all. I was interested in where to place proliferative therapy in my therapeutic protocols. Of these 57 patients, 14 (24.5 percent) responded to manipulation and exercise. An additional 21 (36.8 percent) were treated successfully with a local anti-inflammatory injection (done only once) and then manipulation. The remaining 22 patients (38.5 percent) were treated with the same proliferative therapy protocol that was used in the Lancet study.
There was an 85 percent success rate. This shows that a very large number of low back sufferers do not respond to even careful, sophisticated conservative care. Prolotherapy can cure these people. Since that time, I have increased the percentage of patients that I treat with prolotherapy. I find that there are fewer recurrences due to the resulting ligamentous strengthening.
These studies and many others show that patients get excellent results from prolotherapy. The mechanism for this has also been studied. Prolotherapy acts by stimulating the body's own healing mechanism. The tissue produced is not disorganized scar, but stronger, well organized ligaments and tendons that improve joint function. The following studies show this:
Y. King Liu, Ph.D.
As stated earlier, Dr. Hackett demonstrated that ligaments got thicker and stronger after prolotherapy. In 1983 Y. King Liu injected 5 percent sodium morrhuate solution into the medial collateral ligaments of rabbits. 7 He found that after five injections the ligament mass increased in by 44 percent, the thickness by 27 percent, and the strength of the ligament bone junction increased by 28 percent. This shows that prolotherapy actually causes tissue growth and strengthening.
J.A. Maynard, MD
Dr. Maynard treated rabbit tendons with sodium morrhuate. 8 He found that after six weeks the diameter of the tendons increased by 20 to 25 percent. There was an increase in the cell population with an increase in water content and ground substance, the "glue" that holds our tissues together. There was a wide variety of cells present, including fibroblasts for creation of new collagen and immune cells for cleaning up the old tissue and helping in orientation of the new fibers so that they would be properly aligned. This is the normal appearance of tissues that are undergoing repair and healing.
These findings also show increased circulation that allows an increase in nutrition to the treated tissues, as well as an enhanced ability of the body to bring the cells that are needed for repair and strengthening.
Drs. Dorman and Klein
Drs. Dorman and Klein performed biopsies of posterior sacroiliac ligaments in three patients with chronic low back pain both before and after prolotherapy injections. 6 They found that that after six weekly injections combined with mobilization and stretching exercises, that there was an increase in the average ligament diameter measured by electron microscopy from 0.055 micrometers to 0.087 micrometers. Light microscopy showed an increase in the collagen producing fibroblasts. The ligament orientation was organized and linear, as in normal ligaments. In addition, the range of motion of the patients was significantly increased and their pain was significantly decreased as well, testifying to the clinical success of the treatment. Other studies by these physicians show increased efficiency and decreased energy expenditure in walking after prolotherapy. 15, 16
As the sacroiliac ligaments loosen, the pelvic bones are allowed to twist. This causes the left and right iliac bones to align at different angles. Physicians often use this asymmetry to diagnose sacroiliac laxity and dysfunction. Dr. Dorman has measured the tightening of the pelvis by measuring the difference in pelvic inclination (the angles that each side of the pelvic bones makes with the ground) on the left and right sides before and after prolotherapy. He found that there was a definite tightening of the ligaments, causing a decrease in the difference between the two sides. This also correlated with reduction in pain and increase in function. 17
As you can see, there are many studies that show that prolotherapy is safe and effective. A mildly irritating solution is injected onto the junction of the ligament or tendon and bone. This causes a mild inflammatory response, which stimulates healing. This results in a thicker, stronger, and less sensitive ligament. This increase in strength allows normal joint function and decreases stress on other nearby and at times, even remote structures. Studies show that 75 to over 90 percent of patients appropriately treated with prolotherapy get significant improvement or cure.
- Cyriax J. Illustrated Manual of Orthopedic Medicine, Second Edition. London: Butterworth; 1995. This is the latest and most easily read and used "pure" Cyriax style textbook, but there are many older editions of his two volume works that are more complete.
- Dorman T. Diagnosis and Injection Techniques in Orthopedic Medicine. Baltimore: Williams and Wilkins. Out of print, available from author at 515 W.Harrison Street #200, Kent WA 98032, 206 859 9009.
- Travell J, Simon. Myofascial Pain and Dysfunction. Baltimore: Williams and Wilkins; 1983. Volume one upper body, volume two lower.
- Banks A. A Rationale for Prolotherapy, Journal of Orthopedic Medicine.
- Hackett G. Ligament and Tendon Relaxation Treated by Prolotherapy. 3rd Ed. Springfield: Charles Thomas; 1958. An updated version this book is available through the American Association of Orthopedic Medicine, 435 N. Michigan Ave, Suite 1717, Chicago, Ill 60611-4067, Tel. 800 992 8557.
- Klein R, Dorman T, Johnson C. Proliferant injections for low back pain: histologic changes of injected ligaments and objective measurements of lumbar spinal mobility before and after treatment. Journal of Neurologic and Orthopedic Medicine and Surgery. 1989; 10:123-126.
- Liu Y, Tipton C, Matthes R, Bedford T, Maynard J, Walmer H. An in situ study of the influence of a sclerosing solution in rabbit medial collateral ligaments and its junction strength. Connect Tissue Res. 1983; 11:95-102.
- Maynard J, Pedrini V, Pedrini-Mille A, Romanus B, Ohlerking F. Morphological and biochemical effects of sodium morrhuate on tendons. Journal of Orthopedic Research. 1985; 3:236-248.
- Ongley M, Klein R, Dorman T, Eek B, Hubert L. A New Approach to the Treatment of Chronic Low Back Pain. Lancet. 1987; 2:143-146.
- Klein R, Eek B, DeLong B, Mooney V. A Randomized Double-Blind Trial of Dextrose-Glycerine-Phenol Injections for Chronic, Low Back Pain. J Spinal Disord. 1993; 6:23-33.
- Ongley M, Dorman T, et al. Ligament instability of knees: a new approach to treatment. Manual Medicine. 1988; 3:152-154.
- Dorman T. Prolotherapy: A survey. Journal of Orthopaedic Medicine. 1993; 15.
- Schwartz R. Prolotherapy: A literature review and retrospective study. Journal of Neurology, Orthopedic Medicine, and Surgery. 1991; 12:220-223.
- Gracer R. A study suggesting an algorithm describing the place of proliferative therapy in the treatment of ligamentous pain. Presented at the Institute of Orthopaedic Medicine, Schonreid, Switzerland. 1987. Later published in the Journal of Orthopaedic Medicine, 1988.
- Dorman T, Buchmiller J, et al. Energy efficiency during human walking. Journal of Orthopaedic Medicine. 1993; 13.
- Dorman T, Cohen R, et al. Energy efficiency during human walking: Before and after prolotherapy. Journal of Orthopaedic Medicine. 1994.
- LaCourse M, Moore K, Davis K, Fune M, Dorman T. A report on the asymmetry of iliac inclination. Journal of Orthopaedic Medicine. 1990; 12.
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