Discussion

PRINCIPLE FINDINGS

The results of this retrospective, uncontrolled, observational study show that prolotherapy helped to decrease pain and stiffness in the patients’ treated joints and improved their quality of life that had been compromised due to unresolved ankle pain. The Hackett-Hemwall dextrose prolotherapy gave 90% of them at least 50% pain relief. All (100%) experienced at least 25% or more pain relief. One hundred percent of patients stated their pain was less and their life improved with prolotherapy. Notable improvements in quality of life issues including stiffness, crepitation, range of motion, walking ability, depression, anxiety, sleep, exercise ability, and medication usage was also observed with prolotherapy.

When the data was analyzed for just the 63% (12) of patients who stated their doctors said there were no other treatment options available, significant improvements in pain, stiffness, and exercise ability with Hackett-Hemwall dextrose prolotherapy was also observed.

STRENGTHS AND WEAKNESSES

Our study cannot be compared to a clinical trial in which an intervention is investigated under controlled conditions. Instead, its aim was to document the response of patients with unresolved ankle pain to the Hackett-Hemwall technique of dextrose prolotherapy at a charity medical clinic. Clear strengths of the study are the numerous quality of life parameters that were examined. Quality of life issues such as range of motion, stiffness, athletic (exercise) ability, sleep, anxiety and depression, in addition to their pain levels, are important factors affecting the person with unresolved ankle pain. Decreases in medication usage were also documented. The improvement in such a large number of variables treated solely by prolotherapy is likely to have resulted from prolotherapy. So while there is no medical test to document pain improvement or the progress with prolotherapy, the patients’ increased abilities to exercise and sleep, and their ability to become less dependent on pain medications are measurable changes.

The quality of the cases treated in this study is also a strength. The average person in this study had unresolved ankle pain for three years and four months and had seen over three physicians. Twelve (63%) patients were told by their MDs that there was no other treatment option for their pain. So clearly this patient population represented chronic unresponsive ankle pain. Follow-up time on average of twenty-one months since their last prolotherapy session and having the improvements from the prolotherapy endure, also represented clear strengths and an indication that the positive changes were due to prolotherapy.

Because this was a charity medical clinic with limited resources and personnel, the only therapy initiated was prolotherapy. The prolotherapy treatments could only be given every three months whereas in private practice, the Hackett- Hemwall technique of dextrose prolotherapy is typically given every four to six weeks. If a patient is not improving or has poor healing ability, the prolotherapy solutions may be changed and strengthened and the client is advised on additional measures to improve their overall health. This can include advice on diet, supplements, exercise, weight loss, change in medication, additional blood tests and/or other medical care. Patients are typically weaned immediately off anti-inflammatory and opioid medications that inhibit the inflammatory response that is needed to produce a healing effect from prolotherapy. Since this was not done in this study, the results at this charity clinic are an indication of the minimum level of success with Hackett-Hemwall dextrose prolotherapy. This makes the results even that much more impressive.

A shortcoming of our study is the subjective nature of some of the evaluated parameters. Subjective parameters of this sort included pain, stiffness, anxiety, and depression levels. The results relied on the answers to questions by the patients whose respective changes in their answers were documented pre- and post-prolotherapy. A lack of X-ray and MRI correlation for diagnosis and response to treatment also represents a potential weakness. Lack of physical examination of documentation in the patients’ charts made categorization of the patients into various diagnostic categories impossible.

INTERPRETATION OF FINDINGS

Hackett-Hemwall dextrose prolotherapy was shown to be very effective in eliminating pain and stiffness and improving the range of motion and quality of life in this group of patients with unresolved ankle pain. This included the subgroup of patients told by their MDs that there were no other treatment options for their pain or that surgery was their only option. Current conventional therapies for unresolved ankle pain include medical treatment with analgesics, non-steroidal antiinflammatory drugs, anti-depressant medications, steroid shots, trigger point injections, muscle strengthening exercises, bracing, physiotherapy, weight loss, rest, massage therapy, manipulation, acupuncture, surgery, education and counseling. The results of such therapies are typically short term and often leave the patients with residual pain.

While the exact cause of chronic ankle pain is still debated, this study did show that the Hackett-Hemwall technique of dextrose prolotherapy improves not only the pain level of those with chronic ankle pain, but also a host of other quality of life measures. This treatment to the ankle involves injections into all of the various ligaments that stabilize the part of the ankle where the person is experiencing symptoms. For lateral ankle pain this involves the ligaments of the lateral ankle complex, including the anterior talofibular, calcaneofibular, and posterior talofibular. For anterior ankle pain that is higher, the syndesmotic ligament complex is injected. The ligaments involved include the anterior tibiofibular, posterior tibiofibular, and the distal interosseus membrane between the tibia and fibula. For medial ankle pain, the deltoid ligament with its complex of very strong thick ligaments is injected. Prolotherapy gets at both the superficial and deep deltoid ligaments including the posterior tibiotalar and anterior tibiotalar ligaments.

Prolotherapy is the injection of a solution for the purpose of tightening and strengthening weak tendons, ligaments, or joint capsules. Prolotherapy works by stimulating the body to repair these soft tissue structures. It starts and accelerates the inflammatory healing cascade by which fibroblasts proliferate. Fibroblasts are the cells through which collagen is made and by which ligaments and tendons repair. Prolotherapy has been shown in one double-blinded animal study in a six-week period to increase ligament mass by 44%, ligament thickness by 27%, and the ligament-bone junction strength by 28%.¹⁵ In human studies on prolotherapy, biopsies performed after the completion of prolotherapy showed statistically significant increases in tendon and ligament collagen fibers and diameters by 60%.^{16, 17} Its primary use is in pain management associated with tendinopathies and ligament sprains in peripheral joints.^18,19 It is also being used in the treatment of spine and joint degenerative arthritis.^{20, 21} Some before and after prolotherapy X-ray studies document the reversal of osteoarthritis.^{22, 23}

One explanation for the lack of response of chronic ankle pain sufferers to traditional conservative therapies is that their underlying problem, ligament laxity, is not being addressed. Ligament injury has been implicated as the cause of degenerative osteoarthritis not just the ankle but in joints in general.^24-26 Since prolotherapy is given at the ligament/ bone interface, it presumably stimulated ankle ligament repair in this patient population, causing a marked decrease in pain and improvement in patients’ quality of life. The question of whether or not ankle degenerative changes are reversed with prolotherapy is left for further research.