Patients and Methods

Framework and Setting

In October 1994 the primary authors (R.H., M.H.) started a Christian charity medical clinic called Beulah Land Natural Medicine Clinic in an impoverished area in southern Illinois. The primary modality of treatment offered was Prolotherapy for pain control. Dextrose was selected as the main ingredient in the Prolotherapy solution because of it being readily available, inexpensive (compared to other proliferants), and having a high safety profile. The clinic met every three months until July 2005. All treatments were given free of charge.

Patients

Patients who received Prolotherapy for their unresolved shoulder pain in the years 2001 to 2005 were interviewed via telephone by an independent data collector (D.P.) who had no prior knowledge of Prolotherapy. General inclusion criteria were an age of at least 18 years, having an unresolved shoulder condition more than six months that typically responds to Prolotherapy, and a willingness to undergo at least four Prolotherapy sessions, unless the pain remitted with fewer Prolotherapy sessions.

Interventions

The Hackett-Hemwall technique of Prolotherapy was used. Each patient received 20 to 40 injections with a 15% dextrose, 0.2% lidocaine solution for a total of 20 to 30cc of solution used per shoulder. Each patient was given an intraarticular injection of 5 to 10cc of solution. Around the shoulder, tender areas were also injected, and 0.5 to 1cc of solution was used per extra-articular injection. (See Figure 1.) Tender areas injected on the anterior and superior portions of the shoulder could include the acromioclavicular joint and ligaments, rotator cuff tendon attachments, coracoacromial ligaments, as well as the biceps tendons and glenohumeral ligament attachments. No other therapies were used. As much as the pain would allow, the patients were asked to reduce or stop nonsteroidal anti-inflammatory and narcotic medications.

Outcomes

The independent data collector (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 previous treatments before starting Prolotherapy. Their response to Prolotherapy was also detailed with an emphasis on the effect Prolotherapy had on their need for subsequent treatments and their quality of life. Specifically, patients were asked questions concerning years of pain, pain intensity, overall disability, number of physicians seen and medications taken, quality of life concerns, psychological factors, and whether the response to Prolotherapy continued after the Prolotherapy sessions were finished.

Analysis

For the analysis, patient percentages of the various responses were calculated by another independent person (D.G.) who had no prior knowledge of Prolotherapy. These responses gathered from clients before Prolotherapy were then compared with the responses to the same questions after Prolotherapy. A matched sample t-test was used to determine if there were statistically significant improvements in the before and after Prolotherapy measurements for pain, stiffness, and crunching sensations. Further analyses were done with those patients who stated their medical doctors said that surgery was their only option or that there were no other treatment options for their pain.