Patients and Methods

Framework and Setting

In October 1994, the primary authors started a Christian charity medical clinic called Beulah Land Natural Medicine Clinic in an impoverished area in southern Illinois. 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, is inexpensive compared to other proliferants, and has a high safety profile. The clinic met every three months until July 2005. All treatments were given free of charge.

Patient Criteria

General inclusion criterion were an age of at least 18 years, having an unresolved hip pain condition greater than six months that typically responds to Prolotherapy, and a willingness to undergo at least four Prolotherapy sessions, unless the pain remitted with less number of Prolotherapy sessions.

Interventions

The Hackett-Hemwall technique of dextrose Prolotherapy was used. Each patient received 40 to 60 injections of a 15% dextrose, 0.2% lidocaine solution with a total of 50 to 60cc of solution used per hip. Each patient was given an intraarticular injection of 5 to 10cc of solution via the lateral or posterior approach. Injections were given at the bony attachments of the following structures around the hips including: the greater trochanter, intertrochanteric crest, neck of femur and dorsal ilium; ischiofemoral and ilofemoral ligaments; tensor fasica lata; and gluteus medius, pyriformis, gemellus superior, quadrates femoris, obturator internus, gemellus inferior and vastus lateral muscles. These typical tender spots each injected with 0.5 to 1cc of solution, can be seen in Figure 1. No other therapies were used. As much as the pain would allow, the patients were asked to reduce or stop other pain medications and therapies they were using.

Data Collections

Patients who received Prolotherapy for their chronic hip pain in the years 2001 to 2005 were called by telephone and interviewed by an independent data collector (D.P.) who had no prior knowledge of Prolotherapy. D.P. was the sole person obtaining the patient information during the telephone interviews. The patients were asked a series of detailed questions about their pain and previous treatments before starting Prolotherapy. Their response to Prolotherapy treatments was also documented in detail with an emphasis on the effect the treatments had on their need for subsequent pain treatments and their quality of life. Specifically, patients were asked questions concerning years of pain, pain intensity, overall disability, number of physicians seen, medications taken, stiffness, walking and exercise ability, activities of daily living, quality of life concerns, psychological factors and whether the response to Prolotherapy continued after their last Prolotherapy session.

Statistical Analysis

For the analysis, patient percentages of the various responses were calculated using Microsoft Excel by an independent computer consultant (D.G.), who also had no previous knowledge of Prolotherapy. These 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 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. 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, stiffness, and range of motion in the above three groups (total hips and two subgroups above).

Patient Characteristics

Complete data was obtained on 61 patients representing 94 hips. Of the 61 patients, 72% (44) were female and 28% (17) were male. The average age of the patients was 62 years-old. Patients reported an average of five years, three months of pain. Fifty-four percent had pain longer than four years and 39% had pain longer than six years. The average patient saw three doctors before receiving Prolotherapy. Twelve percent saw six or more doctors and another 22% saw four or five doctors for their chronic hip pain. The average patient was taking 1.1 pain medications. Thirteen percent stated that the consensus of their doctor(s) was that surgery was the only answer to their pain problem, and 33% of patients were told by their doctor(s) that there were no other treatment options for their chronic pain. (See Table 1.)

Treatments Outcomes

Patients received an average of 4.7 Prolotherapy treatments per hip. The average time of follow-up after their last Prolotherapy session was 19 months.

Pain, Crunching Sensation, Stiffness. Patients were asked to rate their pain, crunching sensation and stiffness on a scale of 1 to 10 with 1 being no pain/crunching/ stiffness and 10 being severe crippling pain/crunching/ stiffness. The 61, representing 94 hips had an average starting pain level of 7.0, crunching sensation of 2.0 and stiffness of 4.4. Their average ending pain, crunching and stiffness levels were 2.4, 1.2, and 2.0 respectively. Fifty four percent had a starting pain level of eight or greater, while only 5% had a starting pain level of three or less, whereas after Prolotherapy only 2% had a pain level of eight or greater while 77% had a pain level of three or less. (See Figure 2.)

Range of Motion. Patients were asked to rate their range of motion on a scale of 1 to 7 with 1 being no motion, 2 through 5 were fractions of normal motion, 6 was normal motion, and 7 was excessive motion. The average starting range of motion was 4.3 and ending range of motion was 5.1. Before Prolotherapy 30% had very limited motion (49% or less of normal motion), this decreased to only five percent after Prolotherapy. Prior to Prolotherapy only 36% had 75% or greater of normal range of motion but this improved to 75% after Prolotherapy. (See Figure 3.)


Pain Medication Utilization. Sixty percent discontinued pain medications altogether after Prolotherapy. In all, 75% of patients on medications at the start of Prolotherapy were able to decrease them by 75% or more after Prolotherapy. None of the patients had to increase pain medication usage after stopping Prolotherapy. Before Prolotherapy the average patient was taking 1.1 pain medications but this decreased to 0.3 medications after Prolotherapy. Before Prolotherapy 23% of patients were on two or more pain medications, but this decreased to 2% after Prolotherapy. Sixty-nine percent of clients using additional pain management therapies before Prolotherapy were able to decrease them by 75% or more after treatment.

Walking Ability. Before Prolotherapy, 59% of patients experienced compromised walking ability, but this decreased to 39% after Prolotherapy. Specifically, 38% could walk three blocks or less before Prolotherapy, but this decreased to 10% after Prolotherapy. While 27% of patients could walk less than one block before Prolotherapy, all could walk greater than that distance after Prolotherapy. (See Figure 4.)


Exercise and Athletic Ability. In regard to exercise or athletic ability prior to Prolotherapy, 30% reported totally compromised ability (couldn’t do any athletics), seven percent ranked it as severely compromised (less than 10 minutes), 23% ranked it as very compromised (less than 30 minutes) and a total of 84% ranked it as at least somewhat compromised. After treatments, 80% of patients were able to do 30 or more minutes of exercise with 40% not being compromised at all. (See Figure 5.)


Disability. In regard to quality of life issues prior to receiving treatment, 40% had an overall disability of at least 50% (could only do about half of the tasks they wanted to). This decreased to 11% after Prolotherapy. Sixty-seven percent noted they had at least a 25% overall disability prior to treatments and this decreased to 24% after.

Before receiving Prolotherapy, five of the patients were dependent on someone for activities of daily living (dressing self and additional general self care). All five regained complete independence after Prolotherapy. Before Prolotherapy 11% considered themselves completely disabled in regards to their work situation, but this decreased to seven percent after Prolotherapy.

Depression and Anxiety. Prior to Prolotherapy, 46% of patients had feelings of depression and 52% had feelings of anxiety. After treatments, only 13% had depressed feelings and 21% had feelings of anxiety.

Sleep. Seventy-two percent of patients reported their pain interrupted their sleep prior to Prolotherapy treatments and 71% subsequently experienced improvements in their sleeping ability.

Quality of Life. To a simple yes or no question: Has Prolotherapy changed your life for the better? 98% of patients treated answered “yes.” In quantifying the response:

• Seventy-five percent felt their life was at least very much better from Prolotherapy.
• Sixty percent stated that the results from Prolotherapy have very much continued (>75%) to this day.
• Ninety-eight percent felt that they still have some benefits from the Prolotherapy they received.

• stopped Prolotherapy treatments too soon (before pain completely gone) – 50%
• re-injury – 12%
• new area of pain – 14%
• had increased life stressors – 10%
• had other explanations for the pain – 14%

Of the patients whose pain recurred after Prolotherapy was stopped, 80% were planning on receiving additional Prolotherapy treatments.

Patient Satisfaction. Eighty-five percent of patients knew someone who had received and benefited from Prolotherapy. In fact, seventy-five percent came to receive their first Prolotherapy session because of the recommendation of a friend. Eighty-nine percent of patients treated considered the Prolotherapy treatment to be very successful (greater than 50% pain relief). (See Figure 6.) Ninety-seven percent noted the Prolotherapy was at

Subgroup Analysis

Patient percentages were also calculated for patients who answered “yes” to either of the following two statements:

1. “Before starting Prolotherapy it was the consensus of my medical doctor(s) that there were no other treatment options that he/she knew to get rid of my chronic pain.” and
2. “Before starting Prolotherapy my only other treatment option was surgery.”