Prolotherapy as an Alternative to Surgery: A Prospective Pilot Study of 34 Patients from a Private Medical Practice

Introduction

Chronic pain is a recurring medical dilemma in the United States. It has been estimated that over one third of the American population suffers from chronic pain, and some studies indicate a much higher incidence of pain experienced regularly.^1-3 While chronic pain effects many areas of the body, low back pain is the most common form of chronic pain, with an estimated 80% of people suffering from back pain at some point in their lives.⁴ After back pain, knee and shoulder pain are the most often reported musculoskeletal complaints according to one study.⁵ Businesses in the United States alone lose 61.2 billion dollars per year in loss of productivity because of employee disability due to chronic pain.⁶

This rise in chronic pain is accompanied by an increase in surgical procedures as a pain treatment. Common surgeries that are used to intervene for the pain are knee and shoulder arthroscopy, back, neck or ankle fusion, and knee and hip joint replacement. From the years 1990 to 1996 total hip replacement surgery increased by 23%, one in seven of them were revision surgeries.⁷ In a study looking at total hip and knee replacements performed annually from 2000 to 2004, the number of hip replacements increased from 164,458 to 225,900, and knee replacements increased from 281,534 to 431,485, a jump of 37% and 53% respectively. The same study projected in 2015 that the number of total hip replacement surgeries will reach nearly 600,000, and total knee replacements will reach nearly 1.4 million.⁸ (See Figure 1.) Another study by Cowen, published in Neurosurgery in 2006 states from 1993 to 2003 spinal fusions rose from the 41st most common inpatient procedure to the 19th most common, with cervical fusions increasing by 89%, thoracolumbar fusions by 31% and lumbar fusions by 134%.⁹ A definite increasing trend is seen with musculoskeletal surgical procedures.

With the increase in surgical procedures comes significant increases in healthcare costs, as a total hip replacement has an average cost of $39,299, while a total knee replacement can cost $35,000 or more.^{10, 11} Health care costs associated with knee replacement surgery amounts to around $2 billion annually nationwide and if the hospital charges grow with inflation that cost is estimated to amount to nearly $80.2 billion for all primary revised hip/knee replacement surgeries by 2015.¹² Spinal-fusion surgery has an average hospital bill of more than $34,000, not including professional fees.¹³ Surgical cost is only one limiting consideration relating to chronic pain.

While surgery for pain is sometimes a necessary treatment, it carries risk. A relatively common complication associated with surgical procedures is the need for revision surgery. Statistics from The Hospital for Special Surgery showed that in 1973 the need for hip replacement revisions were fewer than 1%, but by 1983 revision rates had risen to 10%.¹⁴ A later study published in the same journal saw the revision rate between 1990 and 2002 for total hip arthroplasties increase by 3.7 per 100,000 procedures, along with total knee revision arthroplasties increasing by 5.4 procedures for every 100,000.¹⁵ The most common causes of revision total hip arthroplasty are hip instability, mechanical loosening, and infection. (See Figure 2.) Given this trend, it is projected that from the years 2005 to 2030, the hip revision rate will increase by 137% and knee revision rates will have increased by 601%.¹⁶

Revision surgery is only one risk associated with musculoskeletal surgery. Many patients have concerns about other possible risks that accompany surgery which include peri-operative risks such as deep vein thrombosis, along with more intermediate and long-term risks including loosening and wearing of the prosthesis and pseudarthrosis.^17-19 Dislocation is also of concern to hip arthroplasty patients, as it is a regular occurrence and the risk increases with each revision surgery required.^20-24 The need for a blood transfusion is common and of concern, as patients may lose a significant enough amount of blood during a joint replacement surgery to require a transfusion.^25-27 Spinal fusions are sometimes recommended for back pain, but the fusion success rate is sub-optimal and the patient may still experience post-fusion pain, in addition to a long recovery time.^28-30 Artificial discs also present problems by leaving patients with persistent pain symptoms after implantation.^{31, 32} In addition, lumbar fusion failures have been shown to cause radiculopathy, degeneration in adjacent discs, and nerve injuries.^33-36 In relation to the knee, various studies showing arthroscopic debridement and arthroscopy report no benefit for knee osteoarthritis and often leave the patient with chronic pain and complications.^37-40 Ankle replacement surgery has been used for patients with ankle pain, but also reports historically high complication rates, along with a number of failures.^41-43

Because surgery carries risks and complications and often does not cure pain symptoms, patients are seeking alternatives with the same or greater results. Prolotherapy is one alternative that patients are now turning to. Prolotherapy works by initiating a brief inflammatory response, which causes a reparative cascade to generate new collagen and extra cellular matrix giving connective tissue their strength and ability to handle strain and force.^{44, 45} This healing cascade produces fibroblasts, which is critical for the repair of tendons and ligaments. Simply put, the affect of Prolotherapy is similar to that of an injury except with Prolotherapy there is no disruption of the architecture of the tissue. High-resolution ultrasounds have been used to confirm that Prolotherapy does indeed stimulate tissue growth.⁴⁶ One double-blinded animal study by Dr. Liu showed that Prolotherapy increased ligament mass by 44%, ligament thickness by 27%, and ligament bone junction strength by 28%.⁴⁷

The doctor that introduced Prolotherapy into mainstream medicine practice was George S. Hackett, MD.⁴⁸ In a study of 206 traumatic headache patients published by Dr. Hackett and colleagues, 79% were completely relieved of their headaches.⁴⁹ In regards to low back pain, a survey revealed that 82% of 1,178 patients treated with Prolotherapy considered themselves cured.⁵⁰

While Prolotherapy has been traditionally used for ligament and tendon injuries, it has a long history of use in osteoarthritis and other degenerative conditions.^51-53 Because surgery for degenerative conditions carries risks and complications and often does not totally resolve the patients’ pain or even makes it worse; patients are turning to Prolotherapy as an alternative to surgery. Prior studies on Prolotherapy done at a charity clinic run by the primary author have shown that Prolotherapy eliminates pain even in those patients who have been told by their medical doctor(s) that surgery was the only treatment option for their pain.^54-57 (See Table 1.) To further document the success rate of Prolotherapy in helping patients who have been told by an orthopedic surgeon or other physician that surgery was needed to resolve their musculoskeletal pain, this study was undertaken.

Hypothesis: Prolotherapy can resolve pain, even in patients who were told by a medical doctor(s) that surgery is needed for their painful condition.

Objective: To investigate the outcome of patients who underwent Prolotherapy treatment as an alternative to surgery.

Method: In early 2007, unresolved chronic pain patients seeking Prolotherapy at a private medical practice in lieu of surgery were followed prospectively to determine if Prolotherapy treatments resulted in pain relief.

Conclusions: In this study, we observed that patients with unresolved musculoskeletal pain had a statistically significant improvement in their pain and stiffness, as well as significant functional gains in other measures in quality of life, including walking ability, after receiving Hackett-Hemwall dextrose Prolotherapy in lieu of surgery.