Methods
Framework and Setting
In October 1994 the two authors started a Christian charity medical clinic, called Beulah Land Natural Medicine Clinic, in an impoverished area in southern Illinois. Prolotherapy was the primary modality of treatment offered for pain control. Dextrose was selected as the main proliferant in the Prolotherapy solution because of its availability, relative inexpensiveness (compared to other proliferants), and its high safety profile. The clinic met every three months until July 2005, and all treatments were given free of charge.
Patients
Patients who received Prolotherapy for their unresolved knee pain in the years 2003, 2004, and 2005 were called by telephone and interviewed by an independent data collector who had no prior knowledge of Prolotherapy. General inclusion criteria were an age of at least 18 years, presence of an unresolved knee condition that typically responds to Prolotherapy, and a willingness to undergo at least four Prolotherapy sessions, unless the pain remitted with less Prolotherapy sessions.
Interventions
The Hackett-Hemwall technique of Prolotherapy was used and each patient received 20 to 40 injections of a 15% dextrose, 0.2% lidocaine solution with a total of 20 to 30cc of solution used per knee. Each patient was given an intraarticular injection of 5 to 10cc of solution. Around the knee, tender areas were also injected, and 0.5 to 1.0cc of solution was used per extra-articular injection. Tender areas injected included the medial and lateral collateral ligaments, patellar ligament, and pesanserine tendon attachments. (See Figure 1.) No other therapies were used. As much as the pain would allow, the patients were asked to reduce or stop non-steroidal anti-inflammatory and narcotic medications.
Outcomes
The independent data collector 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 stopped.
Analysis
For the analysis, patient percentages of the various responses were calculated by another independent data collector, who also had no previous 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 test was used to determine if there were statistically significant improvements in the before and after Prolotherapy measurements for pain, stiffness, and crunching sensation. Further analyses were done comparing those clients who experienced great success with Prolotherapy (75% or greater pain relief) to those who had minimal success (24% or less of pain relief).
