Prolotherapy: An Expert Interview With Paul H. Goodley, MD

Carol Peckham

Disclosures

August 19, 2009

Editor's Note:

Prolotherapy is a controversial nonsurgical injection procedure for musculoskeletal pain syndromes, predominantly joint pain, that has been practiced for decades. To learn more about this approach, Medscape interviewed Paul H. Goodley, MD, who is the founder of the American Association of Orthopaedic Medicine (AAOM). This organization provides information and educational programs on the diagnosis and nonsurgical treatment, including prolotherapy, of musculoskeletal problems.

Medscape: Would you first give us a brief description of prolotherapy?

Dr Goodley: Prolotherapy, [otherwise known as] regenerative injection therapy (RIT) or reconstructive ligament therapy, was developed about 60 years ago and is a fundamental, effective injection therapy for the repair of injured connective tissues, such as ligaments and tendons. Sclerotherapy and prolotherapy had previously been used synonymously.

"Sclerotherapy" was the original osteopathic designation. Precisely, it is the term used when a true sclerosant is desired for the treatment of varicose veins, esophageal varices, hemorrhoids, or hernias.[1,2,3]

Prolotherapy involves injecting a solution that causes the capillary beds in the injured area to reopen. They do this because the reflexes are literal and interpret the presence of the injected material as injury. After the usual time, however, as with natural healing, the capillary bed recedes again. So, to keep it open for the time necessary to maximize healing, especially after major injury, the injections are usually readministered in a series over a period of weeks or a few months as its effectiveness is assessed.

The changes induced by the procedure essentially duplicate the primary healing process of avascular structures, such as ligaments and tendons, that occurs when the capillary bed reflexively opens after injury. However, since the natural reflex is time-contingent and closes in less than 2 weeks, if repair is not complete before closure, then any residual abnormality at that time will almost certainly persist. A classic example is the persistent floppiness of a sprained ankle that predicts recurring reinjury.

A series of prolotherapy injections over time maintains the reflex activity with the expectation that the involved tissues will strengthen and return to normal tone and tension. There is no controversy with the science.[4,5] Linetsky calls the procedure regenerative injection therapy (RIT) because his observations support that tissue proliferation does not happen but regeneration does.[6] The distinction is important.

Medscape: If prolotherapy is so efficacious, why isn't it standard treatment and why wasn't it embedded in traditional care decades ago?

Dr. Goodley: Prolotherapy is an heir to centuries-old therapies that were initially directed at animals, including treating bowed tendons in horses with hot irons. Hippocrates apparently used fine hot needles to treat recurrent dislocation of the shoulders of his patients. Prolotherapy was first named and systematized for orthopaedic application by George S. Hackett, a general surgeon, in the mid- 1950s,[7,8,9] when orthopaedic surgeons were becoming fascinated with disc herniation.

An outpatient injection procedure with specific indications for the treatment of back pain was incapable of generating interest among them. In 1984, Robert P. Nirschl, at that time the chief medical editor of Orthopedics Today, wrote, "Orthopedic medicine is statistically a major segment of orthopedic practice. With so obvious a practical reality, I am astounded that our orthopedic training programs offer so few opportunities for residents to learn the concepts of orthopedic medicine, rehabilitation and fitness."[10]

In more specific answer to your question, prolotherapy did not make its entry through peer-reviewed papers in the academic setting and remained below general medical consideration. The antipathy against prolotherapy was further abetted by its popularity among osteopathic practitioners at a time when prejudice among allopathic physicians against osteopaths was intense. Prolotherapy is still considered investigational by insurers.[11,12]

Medscape: A 2009 Cochrane review of nonsurgical interventional therapies for low back pain reported that prolotherapy was not effective for chronic low back pain. Could you comment on this?[13]

Dr. Goodley: Their commentary states that they correlated 3 unnamed studies of patients with chronic low back pain [CLBP] as the only criteria. The report disclosed that the studies were dissimilar and couldn't be interrelated. There are obviously many reasons for CLBP. Patients with specific indications for prolotherapy can easily be lost in a sea of randomly selected subjects, with any successful outcome drowned in overbearing and misleading statistics. When there is no attempt to select patients who have lumbar vertebral dysfunction or evidence of ligamentous compromise, when no specific facts concerning accurate diagnosis are presented, I consider such studies completely inadequate to reputably publish judgments.

Of note, 2 other systematic reviews specifically on prolotherapy -- 1 on sports injuries and the other on chronic low back pain -- were more positive.[14,15] The review on prolotherapy for low back pain suggested that although it was not effective when used alone, it might improve pain and disability when used with other co-interventions, including manipulation.Other peer-reviewed studies and authoritative texts on prolotherapy have been published over recent years, with many positive results.[16,17,18,19,20,21,22,23]

A study that deserves special attention concerns professional athletes in whom both competition and the incentive to persist is intense. Such competitors accept pain as a normal consequence of sports and tend to ignore it. At the same time, they fear the inability to participate because of persisting injury and view it as a major threat to their well-being. It is not reasonable to suspect such dedicated individuals to be susceptible to placebo-type therapies. For that reason, the publication of a 2005 study reporting the successful prolotherapy treatment of 24 Argentinean soccer and rugby players is especially notable.[24]

Medscape: How would you first approach a patient with joint pain?

Dr. Goodley: As a preliminary comment, while today many physicians have become convinced of prolotherapy's merit, their perspective often unfortunately remains limited to treatment based on persistent pain per se. They do not consider the primary causes of the pain. In the absence of overriding neurological origins or gross radiologically recognizable alterations, pain in the bony architecture, especially in the vertebral area, is most commonly associated with joint dysfunction.

The first order of business, then, is to diagnose joint dysfunction, with its abnormal articular relationships and inherent impairment of function. The second is to treat it, which requires appreciation of the practical importance of abnormal articular biomechanics. It is my contention, then, that the first therapeutic approach is precise joint manipulation after the attendant soft tissue reactive changes have been relieved as much a possible. (It needs to be noted that most MDs are untrained in joint manipulative concepts and techniques.) This reminds me of a personal incident. I had just successfully presented a paper at a meeting on the appropriate use of manipulation. On my flight back home, the track team from a large state university was also on board. As luck had it, the coach took a seat next to me, and, of course, we talked. When I told him what I had been doing, he smiled and told me that when "his boys" got injured and the team surgeon didn't know what to do, the coach drove them to his chiropractor friend in Santa Monica.

If manipulation relieves the pain and the correction holds, then no further treatment is indicated. However, if it becomes clear that repeated manipulation is only temporarily successful – because ligamentous weakness cannot hold the correction – then, while it "proves" the diagnosis, prolotherapy to restore the connective tissue integrity is the logical next step.[15]

There is some theoretical concern that prolotherapy of a persistently dysfunctional joint performed before reestablishment of articular normalcy might not relieve the symptoms and even contribute to the development of accommodative alterations both proximal and distal to the dysfunction itself.

Incidentally, a balancing corollary concerning manipulation is that its persistent repetition is never indicated; unfortunately, this practice has reinforced traditionalist antipathy to any joint manipulation, and where this procedure remains controversial, there may also be a bias against prolotherapy. Regardless, the extensive literature supporting the appropriate use of joint manipulation techniques is increasingly strong.[25,26,27,28,29,30,31,32,33] Another corollary is that the longer one studies and treats the sometimes-subtle ailments of the musculoskeletal structures, the more evident the power and wonder of the spectrum of the body's unifying reflexes becomes.

Medscape: So could you describe the prolotherapy procedure?

Dr. Goodley: Whether the joints involved are within the carpal bones, the ankle, or the complexity of the vertebral structures, in all cases the principles and intent are to strengthen and restore the full function of the ligament. Hackett coined the phrase, "A joint is only as strong as its weakest ligament." A few years ago, I searched traditional orthopaedic textbooks and other publications that focused on detailed descriptions of ligament injuries and their importance. The literature was sparse and succinct. I found nothing that delved into the importance of identifying ligamentous laxity or the effective treatment of persistent pain, and I obviously found nothing about prolotherapy. (When the problem isn't recognized, it apparently doesn't exist.)

There is an art to any injection therapy, and experienced clinicians vary in their techniques. The following describes my typical practice. Obvious differences are related to the quantity and contents of the injection. There are also indications for injecting solution into the joint space itself.

Repeated examinations over time will demonstrate to what degree there is objective improvement -- diminishing laxity and tenderness and improved function. Virtually any diarthrodial joint of any size can be accurately examined.

It must be fully appreciated that prolotherapy is potentially valuable wherever there is persistent musculofascial pain, articular or not, and whether the pain and tenderness are along the edge of the acromion or the fascial attachments distal to involved elbow structures, or are caused by enthesopathies -- disorders in the origins of the muscle fibers, such as the gluteals, the fascial attachments of major scapular muscles -- all of which I have successfully treated. In the presence of such persistent pain, I have found no contraindications to the skillful employment of this procedure.

My technique is to open a substantial healing field and allow nature to work its wisdom. Cultivating a broad field makes good sense, especially when complex structures are involved, with shifting stresses.

In small joints, like the carpus, a small-gauge needle is used to inject droplets of the solution, approximately 0.1 mLat each site, usually not more than 0.5 mL to a joint. The objective is to visualize "microplanting" -- small amounts of solution distributed within the area of need -- then to have the patience to "let it grow," and then repeat the procedure. Some injecting beyond the discrete area of tenderness has an advantage of distributing an area of reinforcement.

The injections cause a reaction and too much solution or too many injections can cause more posttreatment pain than necessary. Until the tissues declare how they will initially respond, I inject conservatively.

In an area of medium size, such as the lateral collateral ligaments of the knee, "tattooing" along the ligamentous lines of tenderness with about 0.3-mL aliquots is satisfactory. I usually inject about 4 times across the width of each ligament, sometimes making a double row, to inject a total of about 16 to 20 sites on the proximal and distal aspects of both medial and lateral collateral ligaments.

In the lumbar area, many sites are injected, some deep. Since the patient has made a major investment in seeking pain relief and improved function, I inject generously to best assure that a broad healing field has been opened -- injecting about 0.5 mL at each site and possibly using as many as 50 to 70 injections. I have recently observed a skilled clinician who injects far less and at fewer sites than I might -- and he is satisfied with his results. He also does all his injecting with a 25-gauge, 2-inch needle. I use the same needle as much as possible, but I also use a 19-gauge, 3-inch needle (B-D Yale Special). If one is not available, a spinal needle works well. As much as feasible, several sites are injected through one skin entry as the needle is repositioned.

With lumbar pain, my general habit is to inject the following structures: posterior and mid crests of the ilia, lumbosacral fascia (one of the few sites where the needle doesn't touch bone), sacroiliac joints, interspinous ligaments, the iliolumbar ligaments, vertebral facets, and the transverse processes. Obviously, the individual clinical situation directs the procedure. On a personal note, especially in the lumbar area, the obvious must be stated: I will never be skillful enough to select exact ligament sites to inject or even to consider injection of individual ligaments.

Injection of the sacroiliac joints brings to mind the long controversy about whether these joints move at all. During the early '60s, an orthopaedic surgeon approached me while I was still in general practice with the accusatory comment, "How could they move? Look at all those ligaments! Have you ever tried to dissect it?" To which I heard myself reflexively reply, "Since the purpose of ligaments is to restrict motion, if they don't move then what are all those ligaments for?" Mengert stated in his 1943 paper that sacroiliac relaxation has been known since antiquity,[34]and in 1911 Meisenbach published 84 cases on sacroiliac relaxation.[35]

Nor do I believe that the inconvenience and exponential increase in costs associated with injecting under fluoroscopic visualization is routinely justified. And, some prolotherapists will not inject unless they are visualizing the x-rays. I obviously have studied them, but do not usually follow that practice.

This may be repetition, but the tribute was earned. Undoubtedly the most skillful injector I have ever observed is [Milne] Ongley. He could be extraordinarily precise. Incidentally, after injecting, he made a practice of sitting the patient on the table with legs extended and flexing their spine. I haven't followed that practice. (For completeness I need to add that he was not a skillful joint manipulator.)

Medscape: What are some of the solutions used in prolotherapy?

Dr. Goodley: Ideally, prolotherapy solutions are used to initiate connective tissue proliferation. The degree of concomitant inflammation varies and has evolved over time. There are basically 3 classes described: chemical irritants (eg, phenol), osmotic shock agents (eg, hypertonic dextrose and glycerin), and chemotactic agents (eg, morrhuate sodium, a derivative of cod liver oil).[11]

The solutions George Hackett used in 1939were severe: 5% sodium psylliate, with 2% benzyl alcohol (Sylnasol, G.D. Searle) or zinc sulfate, both diluted with Pontocaine 0.15%. Both are harsh, and there is an apocryphal comment about Hackett's treatment: "Do as much injecting as possible the first time because the patient isn't coming back."

Obviously, Dr. Hackett covered the period of intense pain, which he claims was about 6 hours, with narcotics. There is a story that he first learned prolotherapy technique from Louis Schultz, a dentist, who used it for temporomandibular disorders.[36] And the story further elaborates that Schultz learned his technique from a veterinarian.

Again concerning Dr. Ongley, he deserves great credit for advancing the prolotherapy technique. He was the only physician who ever "took a residency" from Dr. James Cyriax (who I will further comment on).

Some time in the 1960s, Ongley first observed Cyriax's use of prolotherapy. He used a more sclerosant than proliferative solution, as was common. Ongley searched the New Zealand Formulary and found an approved solution containing 50% dextrose, 30% glycerin, and 2.5% phenol. It is far gentler and works well. It became known as "Ongley solution" or P2G. It is the solution of choice for clinicians especially until they become familiar and confident with the technique.

As a rule, solutions are mixed 50-50 with local anesthetic. I prefer a 2% solution of lidocaine, or equivalent, so it dilutes to a full-strength solution. The total injected obviously has to be computed to remain well within limits of safety.

In difficult cases, dental pumice in a local anesthetic solution has been used, especially in the deep ligaments of the sacroiliac joints. Its intent is to stimulate tissue strengthening by serving as a continuing irritant -- similar to how pearls form in oysters. It can also be combined with other solutions. Obviously, it must not be used near nerves.

Sodium morrhuate 5% is derived from the sodium salts of cod liver oil fatty acids. Historically, its major use has been for the sclerosant injection of varicose veins. By itself, it is obviously harsh, but a small amount added to Ongley Solution intensifies the action. (On a personal note, if I am using a 5-mL syringe, I might add about 0.5 mL. In recent conversation, Dr. Bjorn Eek, a highly experienced prolotherapist, states that he adds just enough for the solution to change to a milky color. (If more is added, the solution clears.)

Of note, there have been reports that dry needling and, in fact, saline injections have also relieved pain. Theoretically, any agent that invokes the injury response should work. It should be considered that, although such reports allege possible pain relief with these approaches, the duration of pain relief was not described. In addition, no studies have been performed to indicate whether there was a demonstrated regeneration of tissue.

Medscape: How do you manage pain during and after the procedure?

Dr. Goodley: One should regularly provide sufficient analgesia during the procedure so that the patient's discomfort will not be a limiting factor to injection. Incidentally, a pillow under the abdomen helps to flatten the spine during the injections. After the procedure, a large ice pack is often appreciated. The patient rests that day, but I urge as much activity as the patient thinks is acceptable thereafter. I desire that they walk at least half mile a day.

I tell my patients that the day after vertebral injections they should expect to feel as if I'd hit them with a baseball bat. Frequently, they don't. However, anticipating pain, I usually prescribe oxycodone/acetaminophen for a few days. If there is pain, I suggest that the patient takes the pain medication every 2 to 4 hours for a few days. I don't like the idea of "waiting for the pain assault" with the serum levels constantly fluctuating and the patient constantly trying to catch up. Two extra-strength acetaminophen tablets can work well. Usually, pain that requires analgesics is gone by the third day. Fatigue is not to be expected.

Medscape: What about follow-up and repeat procedures?

Dr. Goodley: To maintain the maximum phase of healing, I prefer to repeat a series every 10 to14 days. The object of this approach is to shorten the duration of the treatment period and encourage the patient to complete the treatment. Other experienced clinicians wait a month or longer between injections to allow healing phases to be complete, including a relatively long period of maturation of tissues.

When treating the lumbar spine, I encourage the patient to accept 3 sessions up front, since results take time. After the tissues have matured, additional injections can be given in selected cases - when there is objective evidence of functional improvement and the patient experiences further pain relief. The question of timing may be particularly challenging in major ligamentous damage to the sacroiliac joints, which I have infrequently had to reinject about 7 times.

The patient who holds my record for most injections was treated for approximately 11 years. My patient with the fewest injections was a young woman whom I treated at a wedding. She had sprained her ankle badly years before, and it had remained floppy and still was easily reinjured. At this particular event, she sought my help, and I injected her once with 50% dextrose and local anesthetic. By chance, I saw her again about a year later. She reminded me of my treatment and commented that her previously injured ankle felt so good that her normal one felt weak in comparison. One other example of ankle injury requiring relatively few injections was a high school middle-distance runner who had badly sprained her ankle with persisting damage to the ligaments. She was told she wouldn't be able to compete again. She required about 7 injections and was winning races the next season.

Medscape: How can beginning practitioners best develop prolotherapy skills?

Dr. Goodley: I believe that an excellent condition to start with for the beginning prolotherapist who is still skeptical is lateral instability of the knees, which is very common. The laxity is usually associated with the patient's pain, is easily diagnosed, and the results are almost predictably gratifying.

It goes without saying that developing confidence in injecting deep into the back takes time and some courage. It is always better to be tutored, and a strong knowledge of anatomy is essential.However, confidence truly begins when the clinician is able to "see" it through the skin

Medscape: You had mentioned Milne Ongley a couple of times. I understand that he had been banned from practicing in the United States after treating people in California with the Ongley solution, which hadn't been approved by the FDA. Could you comment on this?

Dr. Goodley: As I have emphasized, Dr. Milne Ongley has made major contributions to the use of prolotherapy. I know that an Internet search will reveal that he practices (or practiced) in Mexico, and because of this some persons who are unacquainted with him may be suspicious of him -- and (thus) prolotherapy. I must respond to this because of my long personal acquaintance with him and knowledge of the circumstances.

Dr. Ongley is an ethical, knowledgeable, and skillful physician. He is (or was) licensed as a physician in New Zealand and the United Kingdom. Years ago -- I think in the ‘80s -- he attempted to obtain licensure in California but did not succeed. He was years past proficiency in basic medical knowledge, and that may have been a factor. I long ago forgot the circumstances. However, there may have been other political reasons as well, specifically ignorance about and objections to prolotherapy. As an example, he was invited to participate to teach a seminar in New Mexico, where he was arrested and jailed [in collusion with the California authorities who were contending with him.]With only a day's notice, over 30 people, mostly patients, flew into Albuquerque from all parts of the country for his preliminary hearing. I was one of them. On the strength of the testimonies, including from several world-class athletes with world record performances, he was released. Milne was forced to establish his practice in Mexico, where, from reports that I heard, he continued to receive high praise for his effectiveness. In summary, prolotherapy, the subject of this discussion, was never an issue.

In medicine especially, it is wiser to be more reflective to restrict one's preliminary conclusions on relevant evidence than to precipitously harshly judge based on what might be extraneous information.

Medscape: Has prolotherapy gained acceptance in the United States?

Dr. Goodley: It depends on what window you look into. From the view of popular acceptance among the population, there are successful prolotherapy-based practices all around the country. I Googled prolotherapy a few weeks ago and came up with 90,500 listings.

Academically, there has been at least 1 course as a university-sponsored event at the University of Wisconsin School of Medicine. If the question relates to its acceptance by orthopaedic surgeons, I'll remind you of the truism: develop a new surgical procedure and every surgeon will have tried it within a few years; develop a nonsurgical procedure and many might have heard of it in 20 years. Orthopaedic surgery has evolved into a conglomerate of surgical subspecialties.

Surgeons follow their inclinations, as all of us do. They are attracted to the surgical suite. By definition, prolotherapy is a nonsurgical procedure.

Medscape: When did you first become aware of prolotherapy, and how would you summarize your experience?

Dr. Goodley: In England, in 1972. While prolotherapy was largely ignored in the US until recently, it was fairly widely accepted in Europe, especially England and Germany. My first observation of its use was in the London office of Dr. James Cyriax, author of the Textbook of Orthopaedic Medicine.

His associate was doing it, and he wanted to impress me with his speed. He did, and that punctuated my honest skepticism.

I’m going to briefly digress to discuss Cyriax. He is central to the nonsurgical issues of orthopaedics. Over time, I knew him well. While he was deservedly controversial -- extraordinarily so, at times -- he, just as deservedly, must be considered the father of orthopaedic medicine which elucidates reasons for his retardation as a deserved force in medicine.

Many of Cyriax's insights were brilliant, especially his shoulder examination and his concept of the capsular pattern associated with adhesive capsulitis. Overall, his book is a monumental contribution. But his "method" of manipulative techniques was poor, and his cervical traction technique was abominable and sometimes dangerous. The story is comprehensively discussed in Relief From Pain.

I returned from Europe an inexperienced skeptic concerning prolotherapy and published my initial impressions in the newsletter of The North American Academy of Manipulative Medicine, an organization that no longer exists. The title was, "Goodley's Travels -- A Voyage Among the Giants." It is available on my Web site (www.drgoodley.com) along with a history of orthopaedic medicine over the past approximately 40 years

Then, many months after my first exposure to prolotherapy, I consulted on a young woman disabled with back pain. She was a workers' compensation case rejected by the system because "there were no objective findings," and she was obviously depressed. According to her history, she was athletic and had been a cheerleader in high school. When I asked her why she wouldn't smile, she told me the pain was too intense. The only finding I could elicit was specific point tenderness in the lumbar midline over one interspinous ligament. I decided to try prolotherapy and injected only that site.When she returned to my office a few days later, she was a cheerleader again. This first foray into prolotherapy was a crude beginning that took a few years to mature.

My time in medicine has occasionally placed me at the spout of a massive funnel, a "court of last resort." With prolotherapy, I have relieved people who had had intractable pain for years and had been unsuccessfully treated with other therapies across the board. They had been their own controls. To consider such depressed, desperate people as “overly influenced by a placebo effect” would, at best, be thoughtless. Two were presuicidal. Sometimes my prolotherapy approach had to be novel. For example, in one patient I had to fashion a large-bore spinal needle into a "fish hook" to inject the anterior medial surface of a scapula.[37] The stories are in Release From Pain.

In summary, prolotherapy is a historically based, scientifically supported, clinically proven, fundamental treatment for restoration of connective tissue integrity. Its course to general acceptance has been delayed by many roadblocks, the reasons for which are not based on any sound reasoning but on bias. The situation is changing totally because of prolotherapy's proven merit.

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