Discussion
Principle Findings
The results of this retrospective, uncontrolled, observational study, show that Prolotherapy helps decrease pain and improve the quality of life of patients with unresolved knee pain. Decreases in pain, stiffness, and crunching levels reached statistical significance with Prolotherapy. The percentage of patients with less knee pain was 95%, and 99% reported long term improvements in stiffness after Prolotherapy. Eighty-six percent of patients decreased their need for additional pain therapies, including medication usage by 90% or more, after Prolotherapy. Eighty-two percent showed an improvement in sleep. For those with depression and anxiety, 86% were less depressed and 82% were less anxious. In regard to activities of daily living, Prolotherapy improved walking ability in 84%, athletic ability in 76%, and dependency on another person in 75% of patients treated. Of the patients treated with the Hackett-Hemwall technique of dextrose Prolotherapy, 95% felt an overall improvement in their quality of life. Ninety-four percent of patients noted their improvement in overall disability has mostly continued since their last treatment.
Strengths and Limitations
Our study cannot be compared to a clinical trial in which an intervention is investigated under controlled conditions. Instead, it is aimed to document the response of patients with unresolved knee pain to Prolotherapy at a charity medical clinic. Clear strengths of the study are the numerous quality of life parameters that were studied. Such quality of life issues as walking ability, stiffness, range of motion, activities of daily living, athletic ability, dependency on others, sleep, anxiety and depression, in addition to pain level, are important factors affecting the person with unresolved knee pain. The improvement in such a large number of knees treated solely by Prolotherapy, even though subjective, is likely to have resulted from the Prolotherapy.
Another strength of this study is that the study population received only Prolotherapy as a treatment for their knee pain; no other treatment modalities were used. Because of the number of patients coming to each clinic (anywhere from 250 to 500), it was impossible to perform numerous modalities on each of them. The financial constraints onthe patient population also precluded them from getting other therapies. Thus, their improvement most likely stems from the Prolotherapy, not any other treatment.
A weakness of this study is that most Prolotherapists using the Hackett-Hemwall method of Prolotherapy see patients every four to six weeks, which is in tune with the normal healing time of ligaments and tendons. Because this was a charity clinic that required numerous volunteers to run it, it was only possible to provide care once every quarter (every three months). Because of this extended follow-up time, the actual cure rates of pain were below what others have found with Prolotherapy.Hackett G. Ligament And Tendon Relaxation Treated By Prolotherapy. Third Edition. Springfield, IL: Charles C. Thomas, Publisher. 1958.<br><br>33. Hackett G. Referred pain and sciatica in diagnosis of low back disability. Journal of American Medical Association. 1957;163:183-185.<br><br>34. Hackett G. Joint stabilization. American Journal of Surgery. 1955;89:968-973.</p>', 230)" onmouseout="hideddrivetip()" href="/prolotherapy/cartilage-regeneration-conclusion#references">[32,33,34] If the Prolotherapy treatments were received more frequently, we would expect the cure rates of pain to be even greater.
Another weakness of this study is that there was not a control group. Because the average person in this study had pain for an average of five years and was an average age of 54, their unresolved knee complaints most likely stem from a chronic degenerated knee. Since these conditions are almost universally progressive and often don’t spontaneously improve, a control group, while helpful, does not negate the results of the study.
An important limitation of our study is the subjective nature of the evaluated parameters. Another limitation is the lack of X-ray and MRI correlation for diagnosis and response to treatment. There was also a lack of physical examination documentation in the patients’ charts to include in the study.
Interpretation of Findings
It is estimated that 80% of people over the age of 50 suffer from some degree of progressive osteoarthritis. Generally speaking, weight-bearing joints, such as the hips, spine, knees, and hands are most commonly involved.cartilage loss in osteoarthritis of the knee. Annals of the Rheumatic Diseases. 1992;51:932-937.</p>', 230)" onmouseout="hideddrivetip()" href="/prolotherapy/cartilage-regeneration-conclusion#references">[35,36] These joints are especially prone to degeneration as a result of the greater wear and tear they experience than other tissues through the body.osteoarthritis of the knee. Annals of the Rheumatic Diseases. 1994;53:90-93.</p>', 230)" onmouseout="hideddrivetip()" href="/prolotherapy/cartilage-regeneration-conclusion#references">[37]
Current conventional therapy of painful osteoarthritis of the knee include: medical treatment with analgesics, non-steroidal anti-inflammatory drugs, and intraarticular corticosteroid or Hyaluronan injections, muscle strengthening exercises, weight loss, the use of assisted devices, such as canes and orthotics, surgical treatment that range from arthroscopic joint debridement to totaljoint replacement, and education and counseling. Many times the results of such therapies leave patients with residual pain.osteoarthritis. The Journal of Rheumatology. 1993;20:16-18.<br><br>40. Stovitz S. NSAIDs and musculoskeletal treatment. The Physician and Sports Medicine. 2003;31:35-52.</p>', 230)" onmouseout="hideddrivetip()" href="/prolotherapy/cartilage-regeneration-conclusion#references">[38,39,40] Because of this; many patients with osteoarthritis are searching for alternative treatments for their pain. One of the treatments they are trying is Prolotherapy.
Prolotherapy is a treatment being performed by more physicians based on positive anecdotal evidence, yet large studies on long term outcomes are limited. From at least one source, some 450,000 Americans have undergone Prolotherapy.[41] There have been numerous studies on animals’ knees showing the efficacy with ProlotherapySurgery. Oak Park, IL: Beulah Land Press. 2004;pp.56-58.<br><br>44. Maynard J. Morphological and biochemical effects of sodium morrhuate on tendons. Journal of Orthopedic Research. 1985;3:236-248.<br><br>45. Schmidt C. Effect of growth factors on the proliferation of fribroblasts from the medial collateral and anterior cruciate ligaments. Journal of Orthopedic Research. 1995;13:184-190.<br><br>46. Hauser R. Prolo Your Sports Injuries Away! Oak Park, IL: Beulah Land Press, 2001;pp.264-287.</p>', 230)" onmouseout="hideddrivetip()" href="/prolotherapy/cartilage-regeneration-conclusion#references">[42-46], but only two in humans.arthritis with and without ACL laxity. Alternative Therapies 2000;2:68-70.</p>', 230)" onmouseout="hideddrivetip()" href="/prolotherapy/cartilage-regeneration-conclusion#references">[47,48] The studies showed Prolotherapy resulted in significant improvements in knee osteoarthritis, including improvements in pain, swelling complaints, and knee buckling frequency. Radiographic improvements in the knee osteoarthritis also occurred.[49] This observational study was the first to show Prolotherapy helps not only the physical components of unresolved knee complaints such as pain, stiffness, range of motion and crunching sensations, but also helps numerous quality of life functions including walking ability, sleep, athletic ability, activities of daily living, and feelings of depression and anxiety. This study also showed that 15 months after their last Prolotherapy session, the vast majority of improvements continued. In this study population, Prolotherapy reduced the patients’ subjective overall disability, medication usage, other pain therapy treatments needed, as well as depressed and anxious feelings. Prolotherapy improved the patients walking and exercise ability, sleep, activities of daily living, and work situation. For the vast majority of the patients, Prolotherapy had a long lasting effect and changed their lives for the better.
In regard to the question, who is a good Prolotherapy candidate? this study compared patients who had great pain relief (greater than 75%) to those that had minimal pain relief (less than 25%) with Prolotherapy. This observational study showed that patients at initial presentation did better with Prolotherapy if they had pain less than three years, starting range of motion of 50% or more of normal, stiffness and crunching level of 7 or less, saw three or fewer M.D.’s prior to Prolotherapy, had an overall disability of 50% or less, could walk greater than 3 blocks, had employment and they were on medications if they were extremely depressed. (See Table 3.)
