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Introduction

Chronic foot and toe pain is a common condition affecting approximately 25% of the population at any given time.¹ The average person spends four hours on their feet and takes between 8,000 and 10,000 steps each day. Each step generates a force, more than 50% the person’s body weight.² Jumping and running adds a force many times the person’s body weight with each stride.³ Thus, during an average day the feet support a combined force equivalent to several hundred tons. It is not surprising, then, that about 75% of Americans experience foot pain at some point in their lives.

The causes of many incidents of metatarsalgia, or forefoot pain, are mechanical, including poorly fitting shoes and improper foot mechanics with walking or running, although the nature and mechanism underlying many types of foot and toe pain is not clearly understood.⁴ Other factors that can lead to foot pain are intense training, certain foot shapes such as high or fallen arches, degenerative arthritis, and excess weight.⁵ For the purpose of this study, the phalanges (toes) are included, as painful conditions involving the toes which can arise from problems in the forefoot or metatarsal region. Bunions, otherwise known as hallux rigidus, and hammertoes (hallux malleus), are two common diagnoses for toe pain whose etiologies can be related to the structures of the forefoot. A multitude of diagnoses can be arrived at for foot/toe pain, though many times the underlying problem, a weakness or injury in the ligaments, tendons or cartilage, is the culprit. For example, hallux rigidus (bunion) “is poorly understood but is thought to be secondary to both hereditary and environmental factors. The fact that bunions occur commonly in families suggests a genetic predisposition from ligamentous laxity and hyperpronation of the foot.”⁶ First ray hypermobility and pes planus (flat feet) are conditions that can lead to bunions.⁷ A study done at the University of Pittsburgh’s Orthopaedic Foot Research Clinic came up with 23 different diagnoses for 98 patients with forefoot pain.⁸ Joint instability and/or hypermobility is what happens when the ligament structure in an area is damaged. This can result in a hallux rigidus, pes planus (flat feet) or other painful maladies such as Morton’s neuroma that can be traced back to an original ligament injury or weakness. Morton’s neuroma, a neuropathy that usually occurs between the 3rd and 4th metatarsals, is not traditionally thought of as being an instability problem. But, “excessive motion between these metatarsals …can result in significantly enlarged 3rd common digital nerve. This enlargement can cause further trauma, worsening the symptoms,” which can be quite severe.⁹

Standard treatment for foot pain is generally conservative, beginning with having the patient wear properly fitting shoes and/or orthotics. If the pain does not resolve, NSAIDs are often prescribed along with some physiotherapy. Patients that do not respond to conservative treatment for foot and toe pain are often considered to be surgical candidates. These procedures include but are not limited to arthrodesis, commonly known as a “fusion;” arthroplasty, which restores the joint, often with some type of implant; chondroplasty, which is the reshaping of the cartilage in the joint; and osteotomy, defined as a bone division to correct a deformity.¹⁰ Despite these measures, a large percentage of foot pain remains, especially in the elderly.¹¹ Because of the limited response of chronic foot and toe pain to traditional therapies, many people are turning to alternative therapies including Prolotherapy for pain control, because it addresses the underlying cause of the problem, ligament injury or weakness.^{12, 13}

The foot, if we include the toes and ankle, contains 26 bones, 33 joints and more than 100 muscles, tendons and ligaments. The function of cartilage is to provide a cushion and allow ease of motion between these various joints. When there is insufficient ligament support to stabilize joint motion, the resultant increase in joint laxity leads to the development and acceleration of articular cartilage injury, commonly known as osteoarthritis, another frequent diagnosis related to foot and toe pain. (Degenerative joint disease is a more apt description as this process of cartilage breakdown is not inflammatory in nature.) Other joints susceptible to degenerative joint disease include the knees, hips, shoulders, fingers and spine due to their supportive ligament structures that can become damaged.¹⁴

Prolotherapy is becoming a widespread form of pain management in both complementary and allopathic medicine. Its primary use is in the pain management associated with tendinopathies and ligament sprains in peripheral joints.^{15, 16} It is also being used in the treatment of spine and joint degenerative arthritis.^{17, 18} In double-blinded human studies the evidence on the effectiveness of Prolotherapy is still being debated, with promising but mixed results being reported.^19-21

George S. Hackett, MD coined the term Prolotherapy.²² As he described it, “The treatment consists of the injection of a solution within the relaxed ligament and tendon which will stimulate the production of new fibrous tissue and bone cells that will strengthen the ‘weld’ of fibrous tissue and bone to stabilize the articulation and permanently eliminate the disability.”²³ Dr. Hackett introduced Prolotherapy to Gustav Hemwall, MD in the mid 1950s. Dr. Hemwall continued Dr. Hackett’s work after his death in 1969, and trained the majority of physicians who practiced the technique, over the next 30 years. Hence, the designation Hackett-Hemwall Prolotherapy was born.

Animal studies have shown that Prolotherapy induces the production of new collagen by stimulating the normal inflammatory reaction.^{24, 25} In addition, animal experiments have shown improvements in ligament and tendon diameter and strength, as evidenced upon post-mortem exam.^{26, 27} While Prolotherapy has a long history of being used for unresolved foot and toe pain,²⁸ no study has been done to date to show its effectiveness. This observational study was undertaken to evaluate the effectiveness of Hackett-Hemwall dextrose Prolotherapy in regard to reducing the subjects’ previously unresolved foot and toe pain, stiffness, and their need for medications, in addition to improving other quality of life measures.