Prolotherapy Research - Unresolved Knee Pain

Results

Patient Characteristics
From a total of 120 patients with unresolved knee pain whose charts were analyzed and who were interviewed via phone, 80 met the inclusion criteria. The main reasons for exclusion were inability to complete treatments due to travel/distance (45%); stopped treatments because of their medical doctor’s recommendation (i.e. needed treatments more frequently or other medical problems) or on their own (30%); inability or unwillingness to answer survey (15%); and other (10%).

A total of 119 knees from 80 patients met the inclusion criteria. Of these, 60% were female and 40% were male. The average age of the patients was 54 years-old. Patients reported an average of five years of pain, 30% had pain for greater than six years, and 19% had pain for between four and six years. Forty-seven percent of patients came because of financial concerns and 43% came upon the recommendation of a friend or family member. The average patient saw 2.3 M.D.’s before receiving Prolotherapy. Thirteen percent were told by one of their physicians that surgery was the only answer to their pain problem, and 38% of patients were told by their physicians that there were no other treatment options for their chronic knee pain. Twenty-one percent were taking one pharmaceutical drug for pain. Twentythree percent were taking two or more drugs for pain. (See Table 1.)

Treatment Outcomes
Patients received an average of four Prolotherapy treatments per knee. The average time of follow-up after their last Prolotherapy session was 15 months.

Patients were asked to rate their pain, stiffness, and crunching sensation on a scale of 1 to 10, with 1 being no pain/stiffness/crunching and 10 being severe/crippling pain/stiffness/crunching. The 119 knees had an average starting pain level of 6.5, starting stiffness level of 4.7, and starting crunching level of 3.8. Patients were asked to rate their mobility on a scale of 1 to 7, with 1 being no motion, 2 through 5 were percentages of normal motion with 2 being 1-24%, 3 being 25-49%, 4 being 50-74% and 5 being 75-99% of normal motion. Normal motion was 6, and 7 was excessive motion or hyper mobility. The average starting mobility level was 4.7.

The patients reported, after Prolotherapy, that their average ending pain level was 2.3. (See Figure 2.) Average ending mobility was 5.4, average ending stiffness 2.0, and average ending crunching 2.1. Of the patients who started with serious pain (level 8 or more), 93.5% ended with less than minimal pain (a level of 3 or less). The percentage of patients who had a decrease in their pain level was 95%. Of these patients, 83% had a significant reduction in pain of at least 50% or higher. (See Figure 3.) Eighty-four percent of patients finished with only minor restrictions in motion (75% or greater of normal motion). More than 83% of patients reported a minimal stiffness level (a level of 3 or less) after completion of the treatments. Eighty percent of patients reported improvements in the crunching level of their knees and 90% of patients were able to decrease their medication usage by 50% or more.

In regard to quality of life issues, prior to receiving Prolotherapy, none of the participants reported normal walking ability. Eight percent used a cane/walker or wheelchair for mobility. Twelve percent said they could walk for a block or less. Twenty-three percent could walk between one and three blocks. Fifty-seven percent stated they could walk more than three blocks, but not as much as they would like. All patients reported improvements in walking ability after Prolotherapy with 65% having normal walking ability, and 91% could walk three blocks or more. (See Figure 4.) Eighty percent reported that their progress had very much continued (75-99%) after the Prolotherapy sessions were stopped.

Concerning athletic ability prior to Prolotherapy, 36% said they could do no athletics, 13% said they could engage in less than 10 minutes, 22% reported they could engage in less than 30 minutes, but all 100% ranked athletic ability as at least somewhat compromised. All patients stated they had some improvements in athletic ability, with 38% getting back to completely normal athletic ability, and 80% stating that those improvements very much continued after the Prolotherapy sessions ended. After Prolotherapy, 78% stated they could now do at least 30 minutes of exercise. (See Figure 5.)

Before Prolotherapy, 16% noted some dependency on another person for activities of daily living; 35% worked full-time, 10% worked part-time, 9% were disabled and unable to work, and 25% were retired; all participants noted some overall disability with 52% having a greater than 50% disability. After Prolotherapy, 97% of patients were totally independent, 39% worked full-time, 11% worked part-time, 4% were disabled and unable to work, and 23% were retired; 29% had no disability whatsoever, with only 13% having a greater than 50% disability. Ninety-four percent of the patients felt that their improvements in disability have mostly continued (50% or greater) after Prolotherapy.

Seventy-four percent of patients had trouble sleeping prior to Prolotherapy with 82% saying they could sleep much better after Prolotherapy. Ninety-two percent stated that the improvement in sleep has at least mostly continued after Prolotherapy (50% or greater). Before Prolotherapy, 41% of patients were depressed and 49% were anxious. After Prolotherapy, 90% of patients were not depressed, and 85% were not anxious. (See Figures 6 & 7.)

To a simple yes or no question: Has Prolotherapy changed your life for the better? 96% of patients treated answered yes. In quantifying the response, 43% felt their life was at least radically better with Prolotherapy. Eighty-eight percent rated Prolotherapy at least very successful in treating their condition (50% or greater improvement) with 50% noting the Prolotherapy to be extremely successful (75% or greater improvement). The percentage of patients able to decrease their additional pain-related treatments including chiropractic, physical therapy, acupuncture, and massage after Prolotherapy was 86%. The percentage of patients able to decrease their medication usage by 50% or more was 90%.

Ninety-four percent of patients know of others who have benefited from Prolotherapy. Ninety-seven percent of patients have recommended Prolotherapy to someone. Eighty-seven percent noted that the results of Prolotherapy have mostly continued (at least 50% retained), and 52% of patients noted that their overall results have very much continued to the present (75% to 99%). Seventy-eight percent noted there were reasons besides the Prolotherapy effect wearing off that were causing their continued pain and/or disability. Of the 78%, 42% of these believe they stopped Prolotherapy too soon (before the pain was totally gone), 20% re-injured the area that had received Prolotherapy, 13% had a new area of pain, 10% had increased life stressors, and 15% had other explanations for the pain. Of the clients whose pain recurred after Prolotherapy was stopped, 81% are planning on receiving more Prolotherapy.

Statistical Analysis
A matched sample test was used to calculate the difference in responses between the before and after measures for pain, stiffness, and crunching. Using the matched sample test on all three variables, all p values reached statistical significance at the 1% level. The p values for pain, stiffness, and crunching were all 0. (See Table 2.) Analysis and calculation of the p-value was done by an independent third party who had no previous knowledge of Prolotherapy.

As previously noted, 38% of patients were told prior to Prolotherapy that no other treatment options existed for their pain. In analyzing these patients, 53% achieved least 75% pain relief with Prolotherapy. All patients stated they had achieved at least some relief of their pain with Prolotherapy. Thirteen percent of patients, prior to Prolotherapy, were told by their physician that surgery was their only option and 90% of them received at least 75% relief from their pain.




To further analyze the data, we asked the question “Were there any characteristic differences in patients who had excellent pain relief with Prolotherapy (greater than 75% of their pain relieved) versus those who had minimal pain relief with Prolotherapy (less than 25% pain relief)?” Figure 8 represents the effectiveness of Prolotherapy compared to how many years the patient had been in pain. As illustrated, 85% of the patients who had pain three years or less prior to Prolotherapy reported excellent results with Prolotherapy (greater than 75% relieved). In regard to patients who had four or more years of pain prior to getting Prolotherapy, 10% experienced minimal pain relief (less than 25% relief) with Prolotherapy. Of patients who started with almost no motion in their knees, 85% had minimal pain relief with Prolotherapy. Of patients whose starting motion was at least 50% of normal, 72% reported excellent pain relief with Prolotherapy. (See Figure 9.)

Another characteristic analyzed was stiffness. In this study, stiffness was measured on a scale of 1 to 10 with 1 being little to no stiffness and 10 being extreme stiffness. As seen in Figure 10, 76% of patients who rated their starting stiffness level as a 7 or less had excellent pain relief following Prolotherapy. Those who had minimal results with Prolotherapy was only 3.4%. But when the initial stiffness level was 8 or more, 14% had minimal results. Using the same scale, patients with an initial crunching level of 6 or less only 3.5% had minimal results with Prolotherapy, while 30% of those, with a level of 7 or more, reported minimal results. (See Figure 11.)

When patients stated their starting walking level was somewhat compromised (able to walk more than three blocks) or not compromised at all, 80% had excellent results and only 1.7% had minimal results with Prolotherapy. When starting walking ability was definitely compromised or worse (at least 25% or greater compromised), 22 % of patients had minimal pain relief. (See Figure 12.)



When a patient’s starting work situation was examined, 36 of the 37 patients that worked had excellent pain relief with Prolotherapy. In regard to those who were disabled at the time of their first Prolotherapy treatment, 44% had excellent pain relief with Prolotherapy. All of the patients who started extremely depressed and on medications reported 100% excellent pain relief with Prolotherapy. Of those who were very depressed, but not on medication, 17% of them reported excellent pain relief.