Results

A. PAIN/STIFFNESS

Pre-study data of all 145 subjects revealed an average pain level of 5.6 and stiffness level of 6.1 on a 10-point numerical pain scale. Post-study data showed pain and stiffness levels were 2.7 and 2.6, respectively. Prior to Prolotherapy, 58% of the patients rated their pain as a level 8 or higher. After Prolotherapy, only 4% rated it that high. Eighty-one percent had a pain level of 3 or less after Prolotherapy, and 69% reported greater than 75% relief of their pain. A full 96% dropped their pain levels by half or more. (See Figure 3.) The improvements in both pain and stiffness levels were significant. (See Figures 4 & 5.)

Figure 3. Percent of patients who reported 50% or greater pain relief after receiving Hackett-Hemwall dextrose Prolotherapy.

Figure 4. Pain levels before and after Hackett-Hemwall dextrose Prolotherapy.

Figure 5. Stiffness levels before and after Hackett-Hemwall dextrose Prolotherapy.

B. RANGE OF MOTION

The average pre-treatment range of motion was 4.2, and the final range of motion was 5.0. Before Prolotherapy, 36% had 49% or less of normal motion, decreasing to only 6% after Prolotherapy. Eighty percent of patients surveyed in the follow-up reported that the improvements in their pain and stiffness levels were still evident one year after treatment. In regard to range of motion, prior to Prolotherapy, 35% noted less than half of normal back motion, but this improved to 7% after Prolotherapy. Before Prolotherapy only 42% noted a slight restriction of motion or normal motion, whereas after Prolotherapy this increased to 80%. (See Figure 6.)

Figure 6. Starting vs ending range of motion levels before and after Hackett-Hemwall dextrose Prolotherapy.

C. MOBILITY

More than 81% of participants showed improvements in mobility following therapy. Prior to treatment, 53% reported difficulty walking and 18% reported they could walk less than one block before Prolotherapy. After Prolotherapy, these numbers dropped to 32% and 2%, respectively. (See Figure 7.) Pre-treatment, 14% of the patients were dependent on someone for activities of daily living (dressing and other general self-care). This went down to 4% after Prolotherapy. There were 12 patients prior to Prolotherapy that rated their dependency on someone else as greater than “minimum” assistance (i.e., needing help with greater than 25% of daily activities). Following treatment, only one patient reported needing that level of help. At one year follow-up, all patients stated that their initial improvements in mobility had continued since receiving Prolotherapy.

Figure 7. Walking ability before and after Hackett-Hemwall dextrose Prolotherapy.

D. ANALYSIS

In regard to exercise or athletic ability prior to Prolotherapy, 31% said they could do no athletics, 14% said they could engage in less than 10 minutes, 19% said they could engage in less than 30 minutes, and a total of 83% ranked it as at least somewhat compromised. After Prolotherapy, 78% of patients were able to do 30 or more minutes of exercise with 38% not being compromised at all. Seventy-three percent of clients stated that the improvement they received with Prolotherapy, in regard to athletic ability, has very much continued. (See Figure 8.)

Figure 8. Athletic ability before and after Hackett-Hemwall dextrose Prolotherapy.

E. ANXIETY AND DEPRESSION

Prior to Prolotherapy, 57% had feelings of anxiety. After Prolotherapy, only 22% had feelings of anxiety. Before Prolotherapy, 49% had feelings of depression and after Prolotherapy, only 13% had depressed feeling. (See Figure 9.) According to the patients, 75% of the improvements in depression and anxiety have very much continued. In regard to sleep, 72% of patients felt their pain interrupted their sleep. After Prolotherapy, 86% had improvements in their sleeping ability and 80% of patients stated that improvement has very much continued.

Figure 9. Depression levels before and after receiving Hackett-Hemwall dextrose Prolotherapy.

F. MEDICATION USE

Ninety-one percent of patients reported reliance on medication to manage their pain prior to Prolotherapy. Following completion of all injection treatments, 75% reported needing no pain medications. The average number of pain medications used per patient decreased from 1 to 0.3 after the study. For those patients who continued to need medication, 97% of them were able to decrease their use by 50% or more.

G. OVERALL RESULTS

To a simple yes or no question: “Has Prolotherapy changed your life for the better?” 97% of patients treated answered “yes.” When asked, “Are there reasons besides the Prolotherapy effect wearing off that are causing your continued pain/disability?” 80% answered “yes.” The patients noted the reasons for some of their returning back pain as the following: 52% said they stopped Prolotherapy treatments too soon (before the pain was completely gone), 16% re-injury, 12% new area of pain, 10% had increased life stressors, and 10% had other explanations for the pain. Of the patients whose pain recurred after Prolotherapy was stopped, 85% are planning on receiving more Prolotherapy.

Ninety percent of patients knew someone who had received Prolotherapy. Seventy-one percent came to receive their first Prolotherapy session because of the recommendation of a friend. Ninety percent of patients treated considered the Prolotherapy treatment they received to be very successful. Ninety-nine percent noted that the Prolotherapy had been at least somewhat successful. Only one patient of the 145 noted that it made no change. No one said the Prolotherapy treatments made them worse. Ninety-four percent have recommended Prolotherapy to someone else.

H. RESULTS FOR THOSE WHO WERE TOLD THERE WAS NO OTHER TREATMENT FOR THEIR PAIN

As previously noted, 38% of patients (55 in number) prior to Prolotherapy were told that there were no other treatment options for their pain. In analyzing these patients, they had a starting average pain level of 7.1 and after Prolotherapy a pain level of 3.1. Prior to Prolotherapy, 58% of the patients rated their pain as a level 8 or higher. After Prolotherapy only 4% rated it that high. Results with stiffness were similar with an average starting level of 7.0 and an ending level of 3.1. The improvements in both pain and stiffness levels were significant. As a group, prior to Prolotherapy, 55% stated that they could not do at least 50% of the tasks they wanted to do. This decreased to 11% after Prolotherapy. In regard to range of motion prior to Prolotherapy, 35% noted less than half of normal back motion, but this declined to 7% after Prolotherapy. Before Prolotherapy only 42% noted a slight restriction of motion or normal motion, whereas after Prolotherapy this increased to 80%. Sixty-four percent had compromised walking ability and 20% could walk less than one block before Prolotherapy. After Prolotherapy, only 35% had compromised walking ability and 4% could walk less than one block. Before Prolotherapy 40% could not exercise at all, whereas after Prolotherapy this was down to 4%. Only 7% ranked their exercise ability as not compromised before Prolotherapy, but after Prolotherapy 58% rated it as not compromised. (See Figure 10.) For those patients on pain medication, 97% of them were able to decrease it by 50% or more. Seventy-eight percent of them were able to decrease their need for additional pain therapies by 50% or more. Before Prolotherapy, 60% felt at least some depression and 71% some anxiety. This decreased to 20% who felt depression and 31% who were anxious after Prolotherapy.

Figure 10. Exercise ability before and after Hackett-Hemwall dextrose Prolotherapy in patients told that no other treatment options existed for their back pain.

In this group of patients, 87% noted that their overall results from Prolotherapy have mostly continued to this day (greater than 50%). Eighty-nine percent of these patients rated the Prolotherapy treatment to be very successful with 62% receiving 75% or greater pain relief. Eighty-nine percent received greater than 50% pain relief with Prolotherapy. In response to the question “Has Prolotherapy changed your life for the better?” 94% answered “yes.”

RESULTS IN THE SURGERY ONLY OPTION GROUP

In regard to the question “Before starting Prolotherapy my only other treatment option was surgery?” 18% of the patients (26 in number) answered “yes.” In analyzing data on these patients, they started out with an average pain level of 6.0, which decreased to 2.1 after Prolotherapy. Eighty-one percent had a pain level of 3 or less after Prolotherapy. Their starting stiffness level was 6.1 and ending was 2.0. Both pain and stiffness improvements were significant. (See Figures 11 & 12.) Sixty-nine percent stated they had greater than 75% pain relief and a full 96% (25 of 26) had 50% or greater pain relief with Prolotherapy. Sixty-five percent noted they could only exercise 10 minutes or less before Prolotherapy, but after Prolotherapy this decreased to 6%. Before Prolotherapy, 65% considered themselves at least somewhat depressed and anxious. This decreased after Prolotherapy to 19% somewhat depressed and 15% somewhat anxious. Seventy-six percent taking pain medications were able to decrease the dosage by 50% or more. The need for additional pain management care also lessened by 50% or more in 77% of the patients after Prolotherapy. Eighty-eight percent of these patients stated, in regard to their pain, that they were at least somewhat better due to Prolotherapy. Fifty percent noted that they were radically better. Twenty three (88.5%) of the patients recommended Prolotherapy to someone else. Eighty-one percent felt that their lives were significantly better because of Prolotherapy. All 100% said that Prolotherapy changed their life for the better.

Figure 11. Pain levels before and after Hackett-Hemwall dextrose Prolotherapy in patients who were told that surgery was their only option.

Figure 12. Stiffness levels before and after Hackett-Hemwall dextrose Prolotherapy in patients who were told that surgery was their only option.

STATISTICAL ANALYSIS

A matched sample paired t-test was used to calculate the difference in responses between the before and after measures for pain, for the entire 145 low back patients, as well as the subgroup of fifty-five patients who were told prior to Prolotherapy that nothing else could be done with their pain, as well as the subgroup of twenty-six patients who told by their medical doctor(s) that surgery was their only option. The paired sample t ratio was computed on this pre-post Prolotherapy study. The paired t ratios for all the groups were highly significant, using N pairs minus one as the degrees of freedom. For the entire 145 low back study participants the paired t ratio was significant (t(144) = 22.5 p<.000001). For the subgroup of low back patients who were told that there were no other treatment options the paired t was also highly significant (t(54) = 26.3 p<.000001). The paired t ratio was highly significant also for the subgroup of low back patients who were told that surgery was their only option (t(25) = 23.8 p<.000001. In summary, for all the low back participants, as well as the two subgroups, their low back pain was significantly reduced at the p<.000001 level by Hackett-Hemwall dextrose Prolotherapy.