Methods

A. PATIENT DATA

A total of 145 patients agreed to participate in the study. Of these, 63% (92) were female and 37% (53) were male, with an average age of 57 years. Patients reported an average of four years and ten months of pain prior to treatment; 55% reported four or more years of pain; and 39% reported six or more years. As a group, they were taking an average of 1.1 pain medications with 27% taking one and 27% taking two or more pharmaceutical drugs for pain. The average patient saw three medical doctors before receiving Prolotherapy. General inclusion criterion included unresolved low back pain, a willingness to undergo at least four Prolotherapy sessions unless the pain resolved with less treatment sessions, and age of at least 18 years. (See Table 1.)

B. TREATMENT PROTOCOL

This pilot study was conducted at Beulah Land Clinic, a free medical clinic located in southern Illinois, between the years 2001 and 2005. The clinic met every three months until July 2005, and all treatments were provided free of charge. Follow-up with patients was completed, on average, one year following treatment.

Dextrose Prolotherapy, using the Hackett-Hemwall technique, was used on all patients for an average of one year. All lower-back ligaments were treated with a dextrose solution chosen as the proliferant because of its ready availability, low cost, and high safety profile. Each patient received 60 to 90 injections of a 15% dextrose, 0.2% lidocaine solution with a total of 60 to 90cc of solution per lower back treatment. Injections were given into and around the sacroiliac joints, as well as tender areas in the lower back. Thus, all soft tissue structures responsible for the intervertebral disc and skeletal stability at the vertebral-sacrum-iliac junction were treated on each patient at each visit.

Injected sites included the sacroiliac, iliolumbar, sacrotuberous, lumbosacral, supraspinus and interspinus, sacrococcygeal and sacrospinus ligaments, as well as the gluteal and pyriformis muscle attachments on the iliac crest. Each site was injected with 0.5 to 1cc of solution. (See Figure 2.) An average of four lower back treatments, given every three months, was provided to each patient. Because nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the expected inflammatory process, patients were asked to discontinue use of pain medications during therapy, if possible.

Figure 2. Typical areas injected with Prolotherapy during low back Hackett-Hemwall dextrose Prolotherapy.

C. DATA COLLECTION

Pre- and post-study data was collected via telephone questionnaire by an independent data collection provider with no prior knowledge of Prolotherapy. Evaluation included current levels of pain/stiffness, disability, range of motion, medication use, quality of life measures, psychological factors, and whether the benefits of Prolotherapy continued after the treatment was stopped. Follow-up data was collected an average of 12 months following each patient’s final treatment.

Patients were asked to rate the following: (1) level of pain and stiffness on a numerical scale from 1 to 10, with 1 indicating no pain/stiffness and 10 indicating severe crippling pain/stiffness; (2) level of disability as a percentage of normal daily activities they could perform prior to and following treatment; (3) range of motion on a numerical scale from 1 to 7, with 1 indicating no motion, 2 through 5 ranges of low-normal motion, 6 completely normal motion, and 7 excessive motion; (4) mobility ; (5) exercise time; (6) depressed and anxious feelings and (7) pre- and post-study use of pain medication.

D. ANALYSIS

Patient percentages of the various responses were calculated before and after Prolotherapy. The patient percentages were also calculated for clients who answered yes to either of the following two questions: Before starting Prolotherapy it was the consensus of my medical doctor(s) that there were no other treatment options that he or she knew of to get rid of my chronic pain? and Before starting Prolotherapy my only other treatment option was surgery?