Prolotherapy Research - Unresolved Elbow Pain

Results for Those Whose MDs Said No Other Treatment Option Was Available
As previously noted, 42% (15) of patients prior to prolotherapy were told that no other treatment options existed for their pain. As a subgroup, they suffered with pain for an average of 59 months. In analyzing these patients, they had a starting average pain level of 6.9 and, after prolotherapy,apain level of 2.2. Prior to prolotherapy, they rated their elbow stiffness a level of 4.7 and, after prolotherapy treatment, a level of 1.9. Fourteen of fifteen (93%) had 50%, or greater, pain relief.

In regard to exercise ability for this subgroup, before prolotherapy treatment, only 33% could exercise greater than 30 minutes because of elbow pain, but this increased to 80% after prolotherapy treatment.

Statistical Analysis
Amatched sample paired t-test was used to calculate the difference in responses between the before and after measures for pain and stiffness for the 36 patients and the subgroup of 15 patients who were told by their medical doctor(s) that there were no other treatment options available. Using the paired t-test, all p values for pain and stiffness for the two groups reached statistical significance at the p < .000001 level (see Table 2).

DISCUSSION

Principle Findings
The results of this retrospective, uncontrolled, observational study show that prolotherapy helps decrease pain and stiffness and improve the quality of life in patients with unresolved elbow pain. The Hackett-Hemwall dextrose prolotherapy gave 64% percent of patients greater than 75% pain relief with 94% of them having 50% or more of their pain relieved. One hundred percent of the patients stated their pain and their life was better after prolotherapy. Notable improvements in other quality of life issues—including range of motion, depression, anxiety, sleep, exercise ability and medication usage—was also seen with prolotherapy.

Data analysis for the 42% (15) of patients whose doctors reported no other treatment options were available, revealed large improvements in levels of pain, stiffness, and exercise ability following Hackett-Hemwall dextrose prolotherapy treatments. 

Strengths and Weaknesses
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 elbow pain to the Hackett-Hemwall technique of dextrose prolotherapy. Clear strengths of the study are the numerous quality of life parameters that werestudied. Quality of life issues such as range of motion, stiffness, athletic (exercise) ability, sleep, anxiety, and depression, in addition to pain level, are important factors affecting the person with unresolved elbow pain. Decreases in medication usage werealso documented. The improvement in such a large number of variables treated solely by prolotherapy is likely to have resulted from prolotherapy treatments. So while thereis no medical test to document pain improvement or the progress with prolotherapy, an increased ability to exercise, sleep, and use less medications are objective changes.

Astrength of this study is the quality of the cases treated. The average patient in this study experienced unresolved elbow pain for four years and one month and had already seen over two physicians for their condition. Fifteen (42%) of the patients were told by their MD(s) that no other treatment option was available for their pain. Clearly, this patient population represented chronic unresponsive elbow pain. Having an average follow-up period of thirty-one months—along with reports of lasting improvements in their quality of life since their last prolotherapy session and an indication that the changes were due to prolotherapy.

Because this was a free clinic with limited resources and personnel, the only therapy provided was prolotherapy. The prolotherapy treatments could only be given every three months. 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/or strengthened. The patient may also be advised of additional measures to improve their overall health, which may include advice on diet, supplements, exercise, weight loss, changes in medications, additional blood tests, and/or other medical care. Patients are often weaned immediately off anti-inflammatory and opioid medications that inhibit the inflammatory response needed to achieve a healing effect from prolotherapy. Since this was not done in this study, the results from this clinic are likely an indication of the lowest 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 included pain, stiffness, anxiety, and depression levels since the results relied on the answers to our questions by the patients. What were documented were the changes in these parameters that occurred with prolotherapy.

There was also a lack of X-ray and MRI correlation for diagnosis and response to treatment. A lack of physical examination 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 quality of life in this group of patients with unresolved elbow pain in this retrospective pilot study. This included the subgroup of patients told by their MD(s) that no other treatment options for their pain existed. Current conventional therapies for unresolved elbow pain include medical treatment with analgesics, non-steroidal anti-inflammatory drugs, anti-depressant medications, steroid injections, trigger point injections, muscle strengthening exercises, bracing, physiotherapy, weight loss, rest, massage therapy, manipulation, surgical treatments, acupuncture, education and counseling. The results of such therapies often leave the patients with residual pain.^33,34,35 Because of this, many patients with chronic elbow pain try alternative treatments for their pain. Simply put, patients who either cannot find relief with traditional therapies or do not like their options—especially if surgery is recommended—search for alternatives. One of the treatments such chronic elbow pain patients are trying instead of surgery is prolotherapy.³⁶

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’s own mechanisms 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 over a six-week period to increase ligament mass by 44%, ligament thickness by 27% and the ligament-bone junction strength by 28%.³⁷ In human studies on prolotherapy, biopsies performed after the completion of prolotherapy showed statistically significant increases in tendon and ligament collagen fiber and diameter of about 60%.^38,39 Ligament injury has been implicated as the cause of degenerative osteoarthritis in joints.⁴⁰ This is significant as it relates to chronic elbow pain, because the main potential sources of the pain arepresumed to be either of muscle origin, or from a tendon or ligament that cannot heal. For lateral elbow pain, this is either the biceps tendon, wrist flexor muscle attachments (lateral epicondyle), or radial (lateral) collateral ligament. For medial elbow pain, the structures include the ulnar collateral ligament or wrist flexor muscle attachments (medial epicondyle).^41,42 Because prolotherapy induces repair of ligaments and tendons at the muscle origin, it can provide a good alternative for those who suffer from chronic elbow pain.