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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 chronic shoulder pain. Decreases in pain, stiffness and crunching levels reached statistical significance to the p<.0000001 level with Prolotherapy, not only for the group as a whole but also for the 21% of the patients that were told that surgery was their only option and for the 39% that were told that their was no other treatment option for their pain. Ninety-nine percent of all patients had less shoulder pain, with 87% having 50% or greater of their pain relieved. In regard to pain medication, 87% decreased their need for it by 75% or more. Eighty-seven percent showed an improvement in sleep. For those with depressed and anxious feelings, 91% were less depressed and 75% were less anxious long term. In regard to overall disability, this decreased from 81% of the patients prior to Prolotherapy to 20% after it. In regard to athletic ability, only 39% of the patients could do more than 30 minutes of exercise prior to Prolotherapy but this increased to 78% after Prolotherapy. In 97% of patients with unresolved shoulder pain for an average of 20 months, the Hackett-Hemwall technique of dextrose Prolotherapy changed their life for the better. (See Table 5.)
Strengths and Weaknesses
Our study cannot be compared to a clinical trial in which an intervention is investigated under controlled conditions. Instead, it’s aimed to document the response of patients with unresolved shoulder 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 studied.
Quality of life issues such as overall disability, stiffness, range of motion, activities of daily living, athletic (exercise) ability, anxiety and depression, in addition to pain level, are important factors affecting the person with unresolved shoulder pain. Decreases in medication usage and additional pain management care were also documented. The improvement in such a large number of shoulders, treated solely by Prolotherapy, is likely to have resulted from Prolotherapy, especially when 61% of the patients were either told by their medical doctors that there was no other treatment for their pain or that surgery was their only option. Another strength is that many of the above parameters are objective. So while there is no one hundred percent definitive medical test to document pain improvement or the progress with Prolotherapy, an increased ability to exercise, have more range of motion and use less medications and other pain therapies are objective changes.
The quality of the cases treated in this study is also a strength. The average person in this study had unresolved shoulder pain for four years, eleven months and had seen over three physicians already. As noted earlier, fifty-seven (61%) of the patients were either told by their MD(s) that there was no other treatment option for their pain or that surgery was their only option. So clearly this patient population represented chronic unresponsive shoulder pain. Having a follow-up time on average of twenty months since their last Prolotherapy session also was a strength, because chronic joint pain typically doesn’t just spontaneously remit. The normal course is actually the opposite, progressively worse pain. So for this group of patients to have such a drastic improvement in their pain and for that improvement to last, gives credence to the notion that the improvement is from the Prolotherapy itself.
Because this was a charity medical clinic with limited resources and personnel, the only therapy that was used 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 strengthened or the patient is advised on additional measures to improve their overall health. This can include advice on diet, supplements, exercise, weight loss, changes in medications, additional blood tests, and/or other medical care. Often patients are weaned immediately off of anti-inflammatory and narcotic medications that inhibit the inflammatory response that is needed to get a healing effect from Prolotherapy. Since this was not done in this study, the results at this charity clinic are 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 of this sort included pain, stiffness, anxiety, and depression levels. The results relied on the answers to questions by the patients. Another shortcoming is the additional pain management care that they were receiving was not controlled. What was documented was the change that occurred in it 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’ chart made categorization of the patients into various diagnostic parameters impossible.
Interpretation of Findings
Musculoskeletal disorders of the shoulder are extremely common, with reports of prevalence ranging from one in three people experiencing shoulder pain at some stage of their lives to approximately half the population experiencing at least one episode of shoulder pain annually.39 Hackett-Hemwall dextrose Prolotherapy was shown to be very effective in eliminating pain and improving the quality of life in this group of patients with chronic shoulder pain. This included the subgroup of patients that were told by their physicians that there were no other treatment options for their pain or that surgery was their only option.
While the differential diagnosis for chronic shoulder pain can include rotator cuff impingement, glenohumeral joint osteoarthritis, rotator cuff tear, bursitis, calcific or bicipital tendinitis, labral tear, myofascial pain syndrome, adhesive capsulitis (frozen shoulder), in the vast majority of cases, the pain relates to degeneration of the rotator cuff.40,41 The incidence of rotator cuff degeneration increases as people age, although even rotator cuff tears may not always be symptomatic. The overall prevalence of tears of the rotator cuff on MRI is 34% among symptom-free patients of all age groups, being 15% for full-thickness tears and 20% for partial-thickness tears.42 In one study, only 28% of all rotator cuff tears were painful and in another study 54% of asymptomatic individuals older than 60 years had either a partial-thickness or full-thickness rotator cuff tear.43,44
The pathophysiological mechanism of this rotator cuff degeneration appears to multifactorial. Several authors have stressed the role of intrinsic tendon physiology as the main cause of degeneration.45,46 A zone of relative hypovascularity in the supraspinatus tendon approximately 1cm from the insertion site on the greater tuberosity, which corresponds to the critical zone where most rotator cuff degeneration and tears occur. This poor blood supply, coupled with chronic tendon overload leads to degeneration in the hypovascular region of the rotator cuff because of poor healing and these areas can eventually progress to rotator cuff tears. Another reason for rotator cuff degeneration is from impingement of the supraspinatus tendon. The supraspinatus tendon is clinically the most important rotator cuff tendon because it is involved, either alone or in combination with one or more additional tendons, in 95% of cuff tears.47
Because of this many patients with chronic shoulder pain are searching for conservative and alternative treatments for their pain.48-50 Searching for alternatives, simply put, are patients who meet the criteria for shoulder surgery but want a more conservative option. Even surgeons themselves often recommend a trial of conservative care for conditions such as rotator cuff tears and subacromial impringement syndrome before surgery is recommended.51,52 In many shoulder conditions, conservative care gives similar results as shoulder surgery with significantly less risk.53,54 Patients realize that total shoulder replacement surgeries, arthroscopic procedures and even cortisone shots carry with them significant risk including prosthesis failure, nerve injury, infection, tissue damage, post-op blood clot and potential for continued pain.55-59
One of the treatments that chronic pain sufferers are using instead of surgery and conventional pain medications including narcotics is Prolotherapy.60, 61 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.
For those patients suffering from chronic shoulder pain, histologic and MRI studies have shown that the pathophysiology is one of rotator cuff degeneration, not inflammation.62-64 In other words, chronic shoulder pain comes from tendon degeneration, in which collagen content within the tendon substance is either missing or changed.65,66 Since Prolotherapy is the injection of a solution for the purpose of tightening and strengthening weak tendons, ligaments or other structures involved in the stability and movement of a joint, it would be expected to be successful for those suffering from chronic shoulder pain.
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