Retrospective, Prospective, Double blind and Histology Studies Showing the Effectiveness of Prolotherapy:

Pain Physician 2005; 8:67-72

Fluoroscopically Guided Cervical Prolotherapy for Instability with Blinded Pre and Post Radiographic Reading

A Case Series

Christopher J. Centeno, MD, James Elliott, MSPT, PhDc, Whitney L. Elkins, MPH, and Michael Freeman, PhD, MPH, DC

Conclusions : The results of this study demonstrate statistically significant correlations between proliferant injections, a reduction of both cervical flexion and extension translation, as well as a reduction in pain VAS score. Since patients with traumatic cervical instability have few viable treatment options other than surgical fusion, cervical proliferant injections under C-Arm fluoroscope may be a viable treatment option

Spine 29(1):9-16, 2004

This study helps prove the effectiveness of prolotherapy for low back pain.

In this prestigious journal, a randomized study by Yelland et al showed the effectiveness of prolotherapy as well as other solutions to help patients with low back pain.  According to the researchers this trials success rates in reducing pain and improving disability are at least as good as those reported for spinal cord stimulation, surgery, or multidisciplinary treatment for patient with low-back pain of shorter duration.. Additionally, they found significant reductions in the chronic low-back pain and disability 2 years after the injections were performed

Retrospective studies showing the effectiveness of prolotherapy:      

Ø     In 1974 Dr. Hemwall presented the results of 2007 prolotherapy patients. The results were: 1871 patients were treated with prolotherapy. 1399 (75.5percent) patients reported complete recovery or cure. 413 (24.3 percent) reported general improvement.  25 (0.2 percent) patients showed no improvement.

Ø     Hackett M.D. Low back pain British Journal of Physical Medicine 1956 19.25-33.  656 patients received a total of 18,000 injections.  12 years after the prolotherapy was completed 82% of the patients considered themselves cured.

Ø     George Hackett presented data in front of the AMA on June 1958 on prolotherapy and cervical whiplash. 1656 patients.   82% of patients considered themselves cured.

Ø     George Hackett, M.D. presented data in front of the AMA on June 1955 on prolotherapy and back pain.  563 patients.   82% of the patients considered themselves cured.

Ø     Schwartz R. Prolotherapy: A literature review and retrospective study Journal of Neurology, Orthopedic Medicine and Surgery 1991;12:220-223  He performed a retrospective study of 43 patients with chronic low back pain who had been unresponsive to other treatments, including surgery.  He gave prolotherapy treatment to the sacroiliac joint area over six weeks. 93 percent of the participants reported significant improvement. Only three of the patients reported no improvement.

Prospective studies showing the effectiveness of prolotherapy:

Ø     Merriman Prolotherapy versus intraoperative fusion in the treatment of joint instability of the spine and pelvis.  Journal of the International College of Surgeons, 1964 42:150-159.   Results: The success rate of the fusion was very variable.  The success rate of the prolotherapy was a 80-90% cure rate.

Ø     Reeves KD Hassanein K Long term effects of dextrose prolotherapy for anterior cruciate ligament laxity: A prospective and consecutive patient study.  Alt Ther Hlth Med 2003;9(2): Using simple dextrose injection into 16 knees with a loose ACL ligament, 10/16 knees were no longer loose by machine measurement at time of follow-up, and symptoms  were improved. Symptoms of osteoarthritis improved even in those who still tested loose

Double blind studies showing the effectiveness of prolotherapy

Ø     Ongley, M. A new approach to the treatment of chronic low back pain. Lancet July 18, 1987. 2:143-146. this is a  double-blind study in the most difficult cases of continuous low back pain patients who suffered for ten years or longer. They divided 81 patients who had surgery, medications, manipulations adjustments, exercise, physical therapy and other treatments, which failed to provide adequate relief for 10 or more years. One group was given manipulation and a reconstructive solution of dextrose, glycerine and phenol. The other group was given sham manipulations and normal saline injections. Great care was taken to insure that neither the patient nor the physicians knew which solution was injected. Both groups were given a total of six treatments. It was found that 88% of the group injected with the reconstructive solution had moderate to marked improvement. Treatment was far superior to the placebo group.

Ø     Klein A randomized double-blind trial of dextrose-glycerine-phenol injections for chronic low back  Journal of Spinal Disorders 1993 6:23-33.  Prolotherapy was shown to be effective versus placebo for treating low back pain.

Ø     Reeves KD Hassanein K  Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Alt Ther Hlth Med 2000;6(2):37-46  Results: Less than one ounce of simple 10% dextrose over 6 months in each joint resulted in  35% reduction of pain, 45% improvement in swelling and 67% improvement in knee buckling as well as a 13 degree improvement in knee range of motion. Treatment solution was superior to placebo solution. (P = .015)

Ø     Reeves KD Hassanein K  Randomized prospective placebo controlled double blind study of dextrose prolotherapy for osteoarthritic thumbs and finger (DIP, PIP and Trapeziometacarpal) joints: Evidence of clinical efficacy. Jnl Alt Compl Med 2000;6(4):311-320 Results: Less than 1 teaspoonful of simple 10% dextrose solution over 6 months in each joint resulted in a 42% improvement in pain and an 8 degree improvement in flexibility. Treatment solution was superior to placebo solution in pain improvement (p = .027) and in flexibility (p = .003)

Studies on the low incidence of complications of prolotherapy

Ø     In 1993 Dr. Dorman published a survey of prolotherapy injections performed by 95 respondents. ¹² These physicians reported on a total of 494,845 patients. Of these 343,897 patients were treated for low back, 98,430 for other areas of the spine, and 26.85 percent also reported non-spine peripheral joint injections. The cumulative years in practice of all the practitioners in the survey were 1092. Only 66 minor complications were reported. These included 24 reports of allergic reactions and 29 cases of pneumothorax (a condition caused by a needle placed into the lung cavity). All of these resolved without serious problems. There were also 14 reports of major complications, defined as the patient needing hospitalization or having transient or permanent nerve damage.

Histology studies in both humans and animals have proven that prolotherapy strengthens ligaments:

Ø     Liu, Y. An in situ study of the influence of schlerosing solution in a rabbit medial collateral ligaments and its junction strength Connective Tissue Research 1983 2:95-102. He found that after five injections the ligament mass increased in by 44 percent, the thickness by 27 percent, and the strength of the ligament bone junction increased by 28 percent. This study showed that prolotherapy actually causes tissue growth and strengthening.

Ø      Maynard J. Morphological and biomechanical effects of sodium morrhuate on tendons Journal of Orthopedic Research 1985 3: 236-248. treated rabbit tendons with sodium morrhuate.  He found that after six weeks the diameter of the tendons increased by 20 to 25 percent.

Ø     Dorman T. Treatment for spinal pain arising in ligaments using prolotherapy: A retrospective study   Journal of Orthopedic Medicine 1991 13(1):13-19 Drs. Dorman and Klein performed biopsies of posterior sacroiliac ligaments in three patients with chronic low back pain both before and after prolotherapy injections. They found that that after six weekly injections combined with mobilization and stretching exercises, that there was an increase in the average ligament diameter measured by electron microscopy from 0.055 micrometers to 0.087 micrometers. Light microscopy showed an increase in the collagen producing fibroblasts. In addition, the range of motion of the patients was significantly increased and their pain was significantly decreased as well.