Prolotherapy for low back pain – a look at the studies

Once patients come in to our Tulsa clinic for prolotherapy they often ask “why don’t more doctors know about this?”

There are several reasons but one of the primary is that there is a thought that there is no evidence that prolotherapy works. You have to understand that physicians are very busy and often don’t have or take the time to read the studies supporting or refuting the scientific evidence. Thus, we often rely on things like the Cochrane Database. the Cochrane Database reviews available literature and draws conclusions about a given topic.

In the case of prolotherapy the Cochrane Database states “When used alone, prolotherapy is not an effective treatment for chronic low-back pain.”(1) That makes it sound like prolotherapy isn’t effective.

However, I have seen the effectiveness of prolotherapy for years and I know just how well it works. The success rate of prolotherapy is in excess of 85%.

So we have a problem. The scientific review states that prolotherapy isn’t effective yet we know it is effective. So what is the real truth?

The answer lies in the studies that have been performed and those that were included in the Cochrane Database. Once you understand these studies it is clear how they came to the erroneous conclusion that prolotherapy doesn’t work.

The largest study on prolotherapy for the low back 110 patients were randomized to receive either saline injections (control group) or dextrose prolotherapy (test group).(3) At the end of the study they found that there was no significant difference between the control group and the test group so the Cochrane Database review inferred that prolotherapy didn’t work. That is typically the point of a randomized trial, to compare an intervention to placebo and see if it works.

The conclusion that prolotherapy doesn’t work based on this study brings up several issues.

First, you have to compare an intervention against a known placebo. Using saline injections cannot be a placebo because we know that there are potential effects. For example, we know that simply inserting a needle into the tissues has a therapeutic effect.(4) However, if you actually read the study you’ll discover that patients in both groups had pain for 14 years on average. You’ll also discover that both groups of patients were very happy with their results.

The authors of the study stated the correct conclusion about the results in the study: “In chronic nonspecific low-back pain, significant and sustained reductions in pain and disability occur with ligament injections, irrespective of the solution injected or the concurrent use of exercises.“(3) In other words prolotherapy works but so do saline injections in this study.

If prolotherapy works and saline injections also work then why not just use saline? Because there are other studies showing significant differences between saline and dextrose prolotherapy injections.(5) Scarpone demonstrated the effectiveness of prolotherapy and these results were sustained for at least 52 weeks.

Another important component of the Yelland study mentioned above (3) is that they limited the amount of solution injected to 10 mL and the average patient only received 7.5 mL. One of the important features of Hackett-Hemwall prolotherapy is its comprehensive approach. It is not uncommon that we will use in excess of 100 mL of solution for a low back prolotherapy procedure. How can we compare a procedure that is only using 10% of what we are using? It is ultimately a very different approach. You simply cannot say one works and one doesn’t when there is such a huge difference in the way these procedures are performed. Tulsa Prolotherapy Testimonials speak for themselves.

George Hackett, MD published a monograph in the 1956 stating a 90% success rate in over 4000 patients without a single complication. These results are consistent with what we see in our clinic.

Physicians today are very “evidence based.” We look for the scientific evidence to support a given therapy. The problem is that many of my colleagues often “throw the baby out with the bathwater.” In other words, a common thought is that if there is no evidence to support the therapy they won’t do it at all. I can’t tell you how many times I’ve heard “well there’s no evidence it works.”

A lack of evidence is NOT evidence against. In other words, just because there isn’t enough evidence to PROVE something works does not mean that it doesn’t work.

Studies on prolotherapy are difficult for several reasons. It is nearly impossible to ‘double blind’ where neither the prolotherapist nor the patient know if they are getting prolotherapy yet make sure that there is absolutely no benefit with the ‘control’ injection. That point is discussed above.

Second, large scale studies of this kind are very difficult and expensive. The bottom line is that there is no money to be made by performing this study so nobody is going to pay for it. That means we don’t have many studies that prove prolotherapy works. But again, a lack of evidence isn’t evidence against.

In fact, there is danger in not using certain therapies simply because there aren’t sufficient studies proving their effectiveness. This point is well made by a study published in the British Medical Journal (BMJ). The authors reviewed studies on the use of parachutes to prevent death in sky-diving and airborne activities. They found no studies proving the effectiveness and stated:

“As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomized controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organized and participated in a double blind, randomized, placebo controlled, crossover trial of the parachute.“(6)

I think it is funny that the authors basically told those who ignore observational data in absence of randomized controlled trials to go jump out of an airplane without a parachute.

We have to do better than this. We simply cannot throw the baby out with the bathwater!

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When it comes to chronic pain you have a few options. You can try physical therapy, medications, natural therapy, accupuncture, massage, chiropractic, surgery, and prolotherapy. There may be others not mentioned as well. Our recommendation is that patients seek the highest success procedure with the lowest cost and the least risk. We believe prolotherapy meets all of these criteria and is worthy of primary consideration.

Prolotherapy is very low-risk, extremely cost-effective, and it works. You have nothing to lose and everything to gain!