Prolotherapy Research - Unresolved Elbow Pain

Patients and Methods

Framework and Setting
The primary authors of this paper started a Christian medical clinic called BeulahLand Natural Medicine Clinic in an impoverished area in southern Illinois. Hackett-Hemwall dextrose prolotherapy was the primary modality of treatment offered for pain control at the clinic. All treatments were given free of charge and the clinic was staffed by volunteer MDs, RNs, MAs and administrative staff. The clinic met every three months from October, 1994 through July, 2005.

Patients
Patients who received prolotherapy for their unresolved elbow pain in the years 2000 to 2005 werecalled by telephone and interviewed by a data collector (D.P.) who had no prior knowledge of prolotherapy.General inclusion criteria werean age of at least 18 years, having an unresolved elbow pain condition that typically responds to prolotherapy, and a willingness to undergo at least four prolotherapy sessions (unless the pain remitted with fewer prolotherapy sessions). Typical elbow conditions that respond to prolotherapy include medial and lateral epicondylitis or
tendinosis, bicepital tendinitis, elbow oteoarthritis, as well as elbow ligament sprains. Patients not included in this study were those who were thought to have ulnar nerve entrapment.

Interventions
The Hackett-Hemwall technique of prolotherapy was used. Each patient received 20 to 30 injections of a 15% dextrose and 0.2% lidocaine solution. Dextrose was selected as the main ingredient in the prolotherapy solution since it is readily available, inexpensive (compared to other proliferants), has a high safety profile and is the most common proliferant used in prolotherapy. A total of 15 to 30cc of solution was used per elbow. Injections were given into and around the areas on the elbow that were painful and/or tender to touch. The typical spots
injected, each with 0.5 to 1cc of solution, can be seen in Figures 1a and 1b. Tender areas injected included the epicondyles and ligament attachments around the elbows. In general, the most tender spots werebasically 3⁄4 inch from the medial and lateral epicondyle where the various ligament attachments are located. These elbow ligaments were the primary focus of the treatment (see Figure 2). The patients were asked to reduce the amount of, or eliminate, the pain medications they were taking.

Data Collection
D.P. was the sole person obtaining the patient information during the telephone interviews. The patients were asked a series of questions about their pain and various symptoms before starting prolotherapy. Their response to prolotherapy was also detailed with an emphasis on the effect prolotherapy had on their elbow pain, stiffness, and quality of life. Specifically, patients were asked questions concerning years of pain, pain intensity, stiffness, number of physicians seen and medications taken, quality of life concerns, psychological factors, and whether the response to prolotherapy continued after the prolotherapy sessions stopped.

Statistical Analysis
For the analysis, patient percentages of the various responses were calculated by an independent computer consultant (D.G.) who also had no previous knowledge of prolotherapy. The responses gathered from patients before prolotherapy were then compared with the responses to the same questions after prolotherapy. The patient percentages were also calculated for patients who answered “yes” to the following question, “Before starting prolotherapy was it the consensus of your MD(s) that no other treatment options existed to cureyour chronic elbow pain?” A matched sample paired t-test was used to determine if there were statistically significant improvements in the before-and-after prolotherapy measurements for pain and stiffness in the above two groups (total elbows and subgroup above).

Patient Characteristics
Complete data was obtained on a total of 36 patients who met the inclusion criteria. Of these, 69% were female (25) and 31% were male (11). The patients’ average age was 53 years-old. Patients reported an average of four years and one month of pain and, on average, patients saw 2.4 MDs before receiving prolotherapy. The average patient was taking one pain medication. Forty two percent (15) stated that the consensus of their medical doctor(s) was that there were no other treatment options for their chronic pain. The demographics of the patients can be seen in Table 1.