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 at which the primary treatment modality offered was Hackett-Hemwall dextrose prolotherapy for pain control. Dextrose was selected as the main ingredient in the prolotherapy solution because it is the most common proliferant used in prolotherapy, is readily available, inexpensive (compared to other proliferants), and has a high degree of safety.¹⁴ The clinic met every three months until July 2005. All treatments were provided at no cost to the patients.

PATIENTS

Patients who received prolotherapy for their unresolved ankle pain in the years 2004 to 2005 at the charity clinic were called by telephone and interviewed by a data collector (D.P.) who had no prior knowledge of prolotherapy. General inclusion criteria were an age of at least 18 years, possessing unresolved ankle pain that typically responds to prolotherapy, and an ability to undergo at least four prolotherapy sessions, unless the pain remitted with fewer prolotherapy sessions. Typical ankle conditions that respond to prolotherapy include ankle instability, ankle ligament sprain, and ankle degenerative arthritis.

INTERVENTIONS

The Hackett-Hemwall technique of prolotherapy was used to treat each ankle. Each patient received 20 to 30 injections of a 15% dextrose, 0.2% lidocaine solution with a total of 15 to 30 cc of solution used per ankle. Injections were given into and around the areas on the ankle that were painful and/or tender to touch. The typical areas injected, each with 0.5 to 1 cc of solution, can be seen in Figure 1. Tender areas injected were on the lateral and medial malleolus, talus, calcaneus, and into and around the tibiotalar joint. The tender areas of the attachments of the deltoid, anterior and posterior talofibular, and calcaneofibular ligaments were also injected. As much as their pain would allow, the patients were asked to cut down or stop the pain medications they were taking.

Figure 1. Typical Prolotherapy injection sites for Hackett-Hemwall Prolotherapy of the ankle.

OUTCOMES

D.P. was the sole person obtaining the patient follow-up assessment information during the telephone interviews approximately 21 months after they were treated. They 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 ankle 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 treatment sessions stopped.

ANALYSIS

The patients’ responses to the telephone questionnaire were gathered and analyzed before prolotherapy and then compared with the responses to the same questions after prolotherapy. The responses were also analyzed in a subset of patients who answered “yes” to the following statement: “Before starting prolotherapy it was the consensus of my MD(s) that there were no other treatment options that he or she knew of to get rid of my chronic ankle pain.”

PATIENT CHARACTERISTICS

Complete data was obtained on a total of 19 ankle patients who met the inclusion criteria. Of these, 63% (12) were female and 37% (7) were male. The average age of the patients was 52 years old. Patients reported an average of 3.3 years (40 months) of pain and on average saw 3.3 MDs before receiving prolotherapy. The average patient was taking 1.0 pain medication. Sixtythree percent (12) stated that the consensus of their medical doctor(s) was that there were no other treatment options for their chronic pain. Eleven percent (2) stated that the only other treatment option for their chronic ankle pain was surgery (See Table 1).