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Understanding of this scientifically sound fundamental for the relief of pain is long overdue.

 Prolotherapy was considered, at best, fringe practice when I hesitantly began using it in 1972, and when I first wrote this piece for my patients two decades ago it was little different. At that time, back pain, especially low back pain, was dominantly misunderstood and heavily subjected to surgeries that only recently have been recognized to have been excessively exploited. Then, as we would wish could happen in them more pervasive and dangerous issues of life, slowly truth prevailed. Tonight, a Google search produced 136,000 pages in less than a second.

Prolotherapy, as I will explain, and is more fully elucidated and illustrated in Relief From Pain available on my website: http://www.drgoodley.com   offers dramatic, inventive examples of its applicability throughout the painful conditions that permeate the musculoskeletal system of which: neck pain, thoracic pain, shoulder pain, headache and afflictions involving the peripheral joints is a sampling of conditions available for pain relief.

Some of the prominent websites written by the new(er) generation of physicians, some of whose practices are literally built on Prolotherapy, feature frequently published email newsletters which publicize what appears to be an exponentially expanding list of opportunities.

While the field is too dynamic and varied for routine, ongoing controlled studies, if the diagnoses and anatomical correlates are satisfactory, then these contributions may reasonably be the fertile products of expanded experience that testifies to Prolotherapy’s place in the primary armamentarium for the relief of pain by strengthening connective tissue and restoring its functional normalcy. 

Prolotherapy (Sclerotherapy, Proliferant Therapy, Ligament Reconstructive Injections, Ligament Reparative Injections) is a technique for repairing ligaments and other connective tissue injuries.

THE PRINCIPLE OF PROLOTHERAPY:

Prolotherapy is the refined application of a centuries old method used to heal what nature was unable to complete on its own. From the searing of a horse’s bowed tendon with a heated iron, to the injection of sclerosant solutions to close varicose veins (or repair a hernia), the old intent was to repair weakened connective tissue.

Healing of an injured tissue primarily happens through the reliable delivery of blood. Vascular tissues, tissues with an inherent blood supply, like muscle, usually heal very well.

On the other hand, connective tissues: ligaments, tendons and fascia are not vascular.  They are designed to function as ropes and supportive sheets. They are made mostly of dense collagen that has few cells and is normally nourished and protected by the persistent flow of body fluid over them – like a “wetlands.” This body fluid is “extravascular” - outside the blood vessels - a vast slow circulation that exits and then reenters the blood vessels and is, in fact, the majority of the body’s fluids at any instant. Its nutrition is sufficient for basic sustenance but is inadequate for significant healing.

The problem of injury repair is addressed by the presence of a vast network of capillaries, the smallest blood vessels in the body, that are immediately available on need to reflexively open and bring in “primary healing” blood. But its duration of action is not contingent on healing. It is time contingent and remains open for a relatively short time, less than two weeks. If the injured ligaments and/or tendons have regained their tension and strength before it closes down, then all is well. If not, weakness and functional deficits will almost certainly persist indefinitely.

Prolotherapy works by mimicking injury and causing the capillary beds to reopen. It does this because the reflexes are literal and interpret the presence of the injection material as injury. After the usual time, however, as with natural healing, the capillary bed recedes again. So, to keep it open in order to maximize healing, especially after major injury, the injections are usually administered in a series over a period of weeks or a few months.

A BRIEF HISTORY:

Prolotherapy began in the United States about sixty years ago.  The story is that the technique began with a veterinarian, who showed it to a dentist who used it for TMJ disorders, who in turn showed it to Dr. George Hackett, an industrial surgeon in Canton, Ohio. The solution he used was primarily sclerosant. It was harsh, causing more scarring than tissue proliferation. The injections were very painful. The story is circulated about an admonition to do all the injecting that could be done the first time because the patient should not be expected to return.

Eventually the technique was refined, significantly b y Dr. Milne Ongley, a New Zealand physician studying in England with Dr. James Cyriax. He popularized a gentler solution composed of dextrose, glycerin and a low percent of phenol that he had found as an approved substance in the New Zealand formulary.[2] It is popularly called “Ongley Solution.” Some call it P2G. It is mixed with local anesthetic. Some add “just enough” Sodium Morrhuate, one of the potent sclerosants, to increase the stimulation commensurate to a particular task such as for the major ligaments of the sacroiliac joint. Ongley doesn’t do that. A number of other variably used solutions are also used.

Slowly at first, the number of practitioners using this method increased. From the relatively few practitioners even thirty years ago, many of whom were osteopaths (who call it Sclerotherapy), today  many recognized “main stream” U.S. physicians advocate its use and some have reported personally benefiting from it. Throughout this time Prolotherapy has been increasingly popular around the world and, and an extensive literature is developing.[3] [4] [5] As of the writing of this article in January 2000, the Internet offers 838 pages concerning this method.

Yet, despite the high frequency of ligament and tendon injuries, even in recent medical publications not specifically written about Prolotherapy, little attention is given to treating their specific needs. For whatever reason, recognition of the special nature of connective tissue injury is still not dominant in orthopedic surgical literature.[6][7][8]

THERAPEUTIC CONSIDERATIONS:

While Prolotherapy is most often considered in the treatment of vertebral pain, virtually all ligaments available to the needle have been injected.  Since the intention is to strengthen (and re-tension) weak ligaments, ideally the history and examination should demonstrate that the weakness exists. A clear case is the patient who is repeatedly successfully manipulated but for whom relief each time is only temporary – like a door that keeps opening after it is shut. In essence, if ligament laxity can be conceptualized and the patient’s pain is persistent despite other reasonable therapies, then Prolotherapy is a legitimate consideration. The facts should be presented to the patient. S/he decides.

Many ligaments in the back are deep. Unless the injections are performed under fluoroscopic control (which markedly increases the cost) precise needle placement is really a relative matter. Knowing the anatomy and, except in certain specific locations, placing the injection on bone fairly close about the ligaments is usually satisfactory. From that, the body’s innate abilities to heal begin. In essence, a field of healing is invoked.

DURATION AND TIMING OF THE INJECTIONS

Concerning the timing, the peak of injection activity passes during the first ten days while some healing continues for about a month. Some prefer to “keep the fire burning” and inject again at about eight to twelve days while others prefer to allow the whole process to play out first. My preference is with the former for a few reasons. Disability is expensive. Philosophically, a process in full activity should be allowed to continue if the temporary increased pain and tenderness of the procedure has cleared. It is common experience that it takes about three times for notable improvement to be evident, so I ask my patients to accept them before concluding about their value. I do not recommend continuing if there has been no effect by then.

In essence, the decision whether more than three injection treatments should be given depends on how improved the patient is at that time. It is, incidentally, not unusual for the patient to experience notable improvement from the first and for improvement to continue with subsequent treatments.

Of course, any untoward side effect requires immediate review. I do not consider the occasional sensation of “sunburn”, sometimes for several weeks, a complication.

When many deep injections are required, as in the low back, the procedure is likely to be sufficiently painful that some form of analgesia is administered beforehand. The use of narcotics and sedatives is common, which the clinician also appreciates so there is no unreasonable constraint on providing all the injecting deemed necessary. For the low back, I have sometimes injected as many as 60 sites (as many as possible through the same initial injection site).

MORE CONCERNING THE INDICATIONS

One of the most immediate questions asked when a “new” tool appears is how precise are its indications. The fast answer is a statistical one, and it will be given, but the reality is that injury is often complex, and fast answers are often incomplete. Most often, especially about the spine, several structures and processes are involved. Their proportions in the individual case may easily not be well understood. And there is always a hurdle concerning how carefully a particular case was studied and with what approaches.

An accurate fast answer is from one of Ongley’s studies.^vii He largely avoided individual variations, as do virtually all statistical studies: He took 81 patients with chronic low back pain with an average of 10 years duration and divided them into two random groups. The group treated with Prolotherapy had “greater than 50% improvement in disability scores, compared with 16 of 41 in the control group; and the number with zero disability scores at six months were 15 and  4, respectively. (p<0.003).” In other words, many in a random sample will be helped with Prolotherapy. This is consistent with how common ligamentous damage is among those who do not spontaneously recover.

So where does Prolotherapy fit in the hierarchy of treatment? Three fundamentals need to be answered:

·        How did the injury occur?

·        Are the biomechanics consistent with ligament injury?

·        Has function been impaired?

While the case of the hypermobile joint exists, as I described, and for which Prolotherapy is likely the only reasonable therapy, most cases are not that direct. So, in considering the complex of findings and how the patient is faring, it is rational to think of using Prolotherapy because ligament damage is common. It is certainly more enlightened to think of a treatment that is logical and uses the body’s rehabilitative abilities than to continue with ultrasound and unlimited medications. Prolotherapy may be the most conservative and scientific treatment available.

WHY IS PROLOTHERAPY “NEW”?

If the science is sound, why is Prolotherapy not (yet) standard? There are many answers. Most reflect attitudes and interests within the medical profession and economics considerably more than legitimate criticism.

• While Prolotherapy was emerging as viable therapy, herniation of the intervertebral disc was discovered as “the cause” of back pain. It consumed the attention of orthopedic surgery for decades. Surgeons operate. Prolotherapy became largely the isolated interest of physicians who largely practiced the medicine of orthopedics.

• Prolotherapy does not attract big money investment. Surgery, x-rays, special catheters, hospital or surgery center procedures generate large corporate profits. Prolotherapy requires an inexpensive solution and skill.

PARTICULARLY IMPORTANT COMMENTS:

Dr. Vert Mooney wrote the initial paper for a book on Prolotherapy.[9]  

“…Then a funny thing happened. Some of my patients who had failed to benefit from my traditional orthopedic surgical approach received some injections of proliferant solution. These made them better. I thought it must be a hoax or a placebo effect. Nonetheless, since I did not understand the material being injected, I had to investigate it further. To my surprise, a prospective scientific study on prolotherapy was about to be initiated in Santa Barbara, California. I was asked to monitor the study to vouch for the methods and result. I actually took on this role with a confidence that my scientific integrity would be able to squash this “hokey” concept of sclerosant injection into ligaments once and for all. I had heard of it, of course; the same concept had worked for the old-time vascular surgeons. However, none of my professors had ever talked about it, and I had never seen an exhibit at an academy meeting about it. What reason was there to believe it worked? But, I wondered, could it work? …To rule out all placebo effect, the results of this prospective study were not evaluated until 6 months after the completion of treatment. The study was described by the editor of the journal Spine as an “elegant study.” It clearly documented the benefits of prolotherapy over injection of local anesthesia. The editors of Spine, however, said they could not publish it, because they did not like the results! Although I was one of the founding editors of Spine, I resigned, and the paper was published elsewhere. (reference viii)

            This short story underscores the bias of the scientific community against innovative concepts that, by the nature of the tissue being evaluated in treatment, have poor capacity for objective measurement…”   

C. Everett Koop, M.D., ScD, Former United States Surgeon General, contributed this comment to a book on this subject.[10]

“…When I was 40 years old, I was diagnosed in two separate neurological clinics as having intractable (incurable) pain. My comment was that I was too young to have intractable pain… To make a long story short, my intractable pain was not intractable and I was remarkably improved (by Prolotherapy) to the point where my pain ceased to be a problem…”

CONCLUSION:

Prolotherapy is potentially valuable in the treatment of any structure whose ligaments or capsule have been damaged. Virtually every reachable joint has been injected. The book on how to maximize the usefulness of Prolotherapy will continue to be written for a long time.

When an injury does not have symptoms and signs clearly dictating another course of treatment, and major neurological abnormalities do not demand priority, but the patient’s condition is not improving, Prolotherapy needs to be considered.

Prolotherapy can be curative in other than joint related conditions. One patient I treated (an industrial case fully reported in my book) continued to have a particular pain at the edge of her left shoulder for years after a failed surgery. She continued to be distressed by the feeling that a spicule of bone was sticking into her skin from the inside. Bone detail x-rays were normal. Nothing abnormal was palpable. A series of Prolotherapy injections along the edge of the acromion (the edge of the shoulder) completely relieved it.