07 Jun CAN ANY RESEARCH PROVE THAT PROLOTHERAPY WORKS?
When trying a new therapy, doctors would ask patients if they felt better. This was before double-blinded studies began. If patients showed improvement it was accepted and presumed that the therapy was effective. With a new therapy, of course it was taught from doctor to doctor and then progressed to medical schools. So if this is how medical therapies were judged, then it is obvious Phototherapy should be taught in every medical school across the nation. So why isn’t it?
Today’s technology with allopathathic medical research, states that double-blinded methods be used with all therapies. Therefore, neither the physician nor the patient is aware which therapy is used. With medications, a sugar pill is used a placebo and pills can be made to look exactly alike therefore the research is much easier. There is no known adequate placebo for Phototherapy and most surgeries, and this is very unfortunate.
When a patient is experiencing joint pain, Prolotherapy may involve multiple injections into area. The injection of Prolotherapy into the ligament/bone interface and joint, induces inflammation that increases fibroblasts in the collage tissue, tendon, ligament, and of course joint tissue.
With the increase in collagen, the ligament, tendon, and/or joint will gain in strength and eliminate the patient’s pain. Typically, a saline solution is being used as a placebo in place of the usual phototherapy solutions in today’s research.
Phototherapy injections versus placebo injections, the techniques are identical. To help lessen the pain of the Phototherapy injections researchers may choose to inject lidocaine or anesthetics into the skin. Placebo injections involve injecting saline solution into the damaged joint. With this method, sticking a needle into the affected site as a placebo, is not a true placebo, but is actually called acupuncture. Dry needling into an affected area can also help diminish or eliminate pain.
The conclusion was that physiological saline is considered to be a more appropriate fluid for injection therapy than local anaesthetics since it is less likely to produce side-effects. The study, therefore, raises questions about the mechanism by which local injections into muscles relieves pain, since there is the possibility that a similar effect might also be achieved by merely inserting a needle into the trigger points .2 One wonders if the reason saline helps with muscle pain is because it induces a mild inflammatory reaction. Such a reaction deems the therapy then Prolotherapy. There have been other studies also to show the pain-reducing effects of saline or just plain sterile water injections.3,4 Also, what worse back pain can there be than labor pain? Subcutaneous injections of sterile water into the area of back pain in women in labor can significantly reduce their pain.5,6,7
In summary, sticking a needle through the skin eliminates pain (acupuncture), sticking a needle through muscles eliminates pain (dry needling), sticking a needle into the skin and injecting water into it eliminates pain, and saline injections into muscles eliminates pain. So if one was to do a Prolotherapy study it would be impossible to have a placebo group because the placebo group even if they were injected with nothing would still be getting a treatment that eliminates pain.
The reason I went through this whole explanation is that the latest study on Prolotherapy used saline injections as the placebo group. The study was printed in Spine and was entitled Prolotherapy Injections, Saline injections, and Exercises for Chronic Low-Back Pain: A Randomized Trial.8 The null hypothesis was that Prolotherapy injections and exercises would be no more effective than the control treatment.
The authors did a good job to assure that their null hypothesis would be true because the control treatment was a treatment. In other words, the control group in this case involved the person getting the exact same shots as the person getting ‘Prolotherapy’ except the solution was different. The Prolotherapy group received injections of hypertonic dextrose and the control group received injections of saline. How much different of an inflammatory reaction do you think would occur between the two. Not too much, but some. The results showed that at 12 months, the proportions achieving more than 50% reduction in pain from baseline by injection group were glucose-lidocaine: 0.46 versus saline: 0.36. The conclusion of the study was that 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.
So in summary, ligament injections work to eliminate the pain. Since the ‘Prolotherapy’ solution did not significantly eliminate pain better than the saline group in this study, some are reporting that this study shows that Prolotherapy doesn’t work.
I wrote to the primary author Dr. Michael Yelland and he wrote me back and said, “Our results may be interpreted as negative by those who focus solely on the lack of significant differences between groups and choose not to notice the sustained and significant reductions in pain and disability lasting two years.9 I let him know that the results of this study in regard to the dextrose Prolotherapy group are far inferior to what achieve (50% pain reduction in this study, versus 75% cure rate with Hackett-Hemwall Prolotherapy!). I encouraged him or his colleagues in Australia to contact me about getting additional Prolotherapy training for him or his colleagues but haven’t heard back.
In this study the amount of solution injected was far less than is used in a typical Prolotherapy treatment by a Hackett-Hemwall Prolotherapist (30cc versus 80cc). In this study the deep s/i ligaments were not injected routinely whereas in Hackett-Hemwall Prolotherapy they are typically included in a comprehensive low back treatment. In this study, injections were performed through an anesthetized wheal of skin over each site. Thus, an intradermal injection of anesthetic was done over the area of pain in both the Prolotherapy group and the control group. As I alluded to above, this is an active treatment for pain. It has been shown in various studies to decrease pain, so the ‘placebo’ group in this study was an active treatment group. In this study if no improvement was noted by the fifth session of injections, the deeper interosseous sacroiliac ligaments on the affected sides or sides were also treated. Again, this area is typically done at all visits with Hackett-Hemwall Prolotherapy.
So what did this study show? At 12 months, the proportions of all participants who rated their pain and disability as better than at enrollment were 76% in the Dextrose-Prolotherapy group and 68% in the Saline-Prolotherapy group. I am calling it Saline-Prolotherapy group because the technique of Prolotherapy was used. In other words, a needle was used to inject solution into the bone-ligament interface and such a ‘trauma’ would induce a mild inflammatory reaction. At 12 months, the proportions of participants who achieved at least a 50% reduction of pain in each group were glucose-lidocaine Prolotherapy of 46% and Saline- Prolotherapy 36%.
The latest study on Prolotherapy once again showed that Prolotherapy works at eliminating pain. The study looked at two different solutions: hypertonic dextrose and saline. Hypertonic dextrose eliminated pain slightly better than saline but it was not statistically significant.
In this study, and others regarding Prolotherapy, the difficulty lies in the fact that there is not a placebo group that can satisfy the true requirements of a placebo. A placebo is to have no biological effect. Studies have shown that sticking a needle into an area of pain with or without injecting a substance into the area has a biological effect and helps eliminate the pain. As such, Prolotherapy studies can just compare one solution to another. As long as the studies show that both solutions work, as the latest study has, instead of allopathic physicians claiming Prolotherapy doesn’t work (because the Prolotherapy solution group did not reduce pain significantly more than the control injection group), they should accept the fact that simple solutions can eliminate people’s pain as long as the technique of Prolotherapy is used. Injecting sugar or saline-type solutions into the ligament/bone interface eliminates chronic pain. This is consistent with the current thinking among Prolotherapy physicians that the chronic pain that people suffer from is at the ligament/bone interface called the fibro-osseous junction. Prolotherapy by inducing a mild inflammatory reaction in the area helps it to repair. Once this interface is strong the person’s chronic pain is eliminated.
1. Garvey, T. A prospective, randomized, double-blind evaluation of trigger point injection therapy for low back pain. Spine. 1989; 14: 962-964.
2. Frost, F. A control, double-blind comparison of mepivicaine injection versus saline injection for myofascial pain. The Lancet. 1980; March 8, pp. 499-501.
3. Jenson, M. Improved patient compliance after trigger point injections using a 0.9% sodium chloride compared to bupivacaine 0.025% for patients with myofascial pain syndrome. The Pain Practitioner. 2001; Fall, pp. 4-6.
4. Byrn, C. Subcutaneous sterile water injections for chronic neck and shoulder pain following whiplash injuries. The Lancet. 1993; 341: 449-452.
5. Trolle, B. The effect of sterile water blocks on low back pain labor pain. Am J Obstet Gynecol. 1991; 164: 1277-81.
6. Ader, L. Parturition pain treated by intracutaneous injections of sterile water. Pain. 1990; 41: 133-8.
7. Byrn, C. Subcutaneous sterile water injections for chronic neck and shoulder pain following whiplash injuries. The Lancet. 1993; 341: 449-452.
8. Yelland, Michael. Prolotherapy Injections, Saline Injections, and Exercises for Chronic Low-Back Pain: A Randomized Trial. Spine; 2004: 9-16.