Study Strengths and Limitations

By virtue of its design, this pilot study cannot be compared to randomized placebo-controlled clinical trials. Instead, its aim was to document the response of patients with unresolved low back pain to the Hackett-Hemwall technique of dextrose Prolotherapy at a charity medical clinic.

Multiple quality of life measures were assessed, including mobility, stiffness, range of motion, and activities of daily living, which, in addition to pain level, are important factors affecting the individual with unresolved low back pain. Decreased reliance on pain-relief medication was also documented.

Because this data was collected from patients at a free clinic, no control group was used to validate the data collected, and no imaging studies are available to corroborate patient reports or provide clinical proof of improvements. Instead, the authors relied on the objective observations of the patients themselves regarding levels of pain and if and how their daily functioning improved. Given the size of the study group, it is likely that Prolotherapy, rather than other, concomitant factors not controlled for, is responsible for the improvements seen.

The individuals participating in this study represent a typical cross-section of chronic low back pain patients, including gender, age, location and levels of pain/stiffness, and years of affliction. Before seeking treatment at the clinic, participants averaged four years and ten months of low back pain and had seen at least three physicians to resolve the problem. Prior to Prolotherapy, fifty-five (38%) of the patients said they were told there were no other treatment options for their pain and twenty-six (18%) of the patients said their medical doctor(s) believed that surgery was their only option. Adding to the study’s validity is the length of time between each patient’s final treatment and the follow-up interview. In the authors’ view, the one-year time frame was sufficient to gauge Prolotherapy’s long-term effectiveness.

Because this was a charity medical clinic with limited resources and personnel, the only therapy provided was Prolotherapy, and treatments were given only at three-month intervals. In private practice, the Hackett-Hemwall technique of dextrose Prolotherapy is typically given every four to six weeks and often used in conjunction with a dynamic whole-body approach to pain relief. In patients who show little progress or who demonstrate poor healing capacity, the injection proliferants may be changed and strengthened, or additional actions recommended to improve overall health. Such complementary measures may include advice on diet, supplements, exercise, weight loss, changes in medications, additional blood tests, and other medical care. Most private-practice clients are also immediately weaned off of anti-inflammatory and narcotic medications that inhibit the inflammatory response needed to obtain a healing effect from Prolotherapy. Though cessation of medication use was highly recommended for all clinic study participants, not all patients were able to comply. Taking into account the lack of complementary therapies used during this pilot study, the results may indicate only the lowest level of success possible with Hackett-Hemwall Prolotherapy.

Like all case studies lacking a control group to limit variables impacting outcomes, our study results are a snapshot only of the parameters evaluated and are necessarily subjective. The results are based solely on the answers provided by the participants to the questions posed by the questionnaire. No radiograph or MRI correlation for diagnosis and response to treatment is available, and a lack of physical examination documentation in the patients’ charts made categorization of participants into various diagnostic parameters impossible. Medication use, level of activity, and other pain management care during the course of treatment are variables that could influence results. What was documented were simple outcome measures that occurred prior to and following treatment with Prolotherapy.