Prolotherapy ("Proliferative Injection Therapy") involves injecting an otherwise non-
pharmacologicalPharmacology is the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and exogenous chemicals that alter normal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals...
and non-
activePharmacological or biological activity is an expression describing the beneficial or adverse effects of a drug on living matter. When the drug is a complex chemical mixture, this activity is exerted by the substance's active ingredient or pharmacophore but can be modified by the other constituents....
irritant solution into the body, generally in the region of tendons or ligaments for the purpose of strengthening weakened connective tissue and alleviating musculoskeletal
painPhysical Pain is the unpleasant feeling common to a headache and a stubbed toe. It typically consists of negative affect and aversion, and has location, duration, intensity and a distinctive quality...
.
Prolotherapy can be distinguished from
sclerotherapySclerotherapy is a procedure used to treat blood vessels or blood vessel malformations and also those of the lymphatic system. A medicine is injected into the vessels, which makes them shrink. It is used for children and young adults with vascular or lymphatic malformations. In adults,...
. Sclerotherapy is the use of injections of caustics into the veins, in vascular surgery and dermatology, to remove
varicose veinsVaricose veins are veins that have become enlarged and tortuous. The term commonly refers to the veins on the leg, although varicose veins can occur elsewhere. Veins have leaflet valves to prevent blood from flowing backwards . Leg muscles pump the veins to return blood to the heart, against the...
and other vascular irregularities.
Prolotherapy ("Proliferative Injection Therapy") involves injecting an otherwise non-
pharmacologicalPharmacology is the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and exogenous chemicals that alter normal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals...
and non-
activePharmacological or biological activity is an expression describing the beneficial or adverse effects of a drug on living matter. When the drug is a complex chemical mixture, this activity is exerted by the substance's active ingredient or pharmacophore but can be modified by the other constituents....
irritant solution into the body, generally in the region of tendons or ligaments for the purpose of strengthening weakened connective tissue and alleviating musculoskeletal
painPhysical Pain is the unpleasant feeling common to a headache and a stubbed toe. It typically consists of negative affect and aversion, and has location, duration, intensity and a distinctive quality...
.
Prolotherapy can be distinguished from
sclerotherapySclerotherapy is a procedure used to treat blood vessels or blood vessel malformations and also those of the lymphatic system. A medicine is injected into the vessels, which makes them shrink. It is used for children and young adults with vascular or lymphatic malformations. In adults,...
. Sclerotherapy is the use of injections of caustics into the veins, in vascular surgery and dermatology, to remove
varicose veinsVaricose veins are veins that have become enlarged and tortuous. The term commonly refers to the veins on the leg, although varicose veins can occur elsewhere. Veins have leaflet valves to prevent blood from flowing backwards . Leg muscles pump the veins to return blood to the heart, against the...
and other vascular irregularities. Prolotherapy is the use of injections in the treatment of connective tissue weakness and musculoskeletal pain. Prolotherapy is also called "proliferation therapy" and "regenerative injection therapy."
Prolotherapy is often used as an alternative to invasive arthroscopic surgery. A double-blind placebo-controlled study on arthroscopic surgery for
osteoarthritisOsteoarthritis , is a group of diseases and mechanical abnormalities involving degradation of joints, including articular cartilage and the subchondral bone next to it...
of the knee was published in the
New England Journal of MedicineThe New England Journal of Medicine is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is the oldest continuously published medical journal in the world, and is the most widely read, cited, and influential general medical periodical in the...
in July 2002 and concluded that the group that received actual arthroscopic surgery did not report better function or pain than the placebo group. Arthroscopic surgery of the knee is, however, rarely performed for the indication of osteoarthritis, but rather for mechanical tears or disruptions of cartilaginous tissue. Prolotherapy is not intended to address this type of problem. Doctors and surgeons have given anecdotal accounts of successful treatment for knee injuries, shoulder separation, and typical injuries to golfers (
epicondylitisEpicondylitis refers to an inflammation of an epicondyle.Types include:* lateral epicondylitis, also known as tennis elbow* medial epicondylitis, also known as golfer's elbow...
, shoulder strain, lower back strain and injury, hip and knee injury) However, the vast majority of established musculoskeletal health care professionals do not support prolotherapy as mainstream treatment pending further investigation.
As of April 2005, doctors at the
Mayo ClinicMayo Clinic is a non-profit organization and internationally renowned group medical practice headquartered in Rochester, Minnesota. Its headquarters consist of the Mayo Medical School, the Mayo Graduate School, the Mayo College of Graduate Medical Education, and several other health science schools...
began supporting prolotherapy. Robert D. Sheeler, MD (Medical Editor,
Mayo Clinic Health letter) first learned of prolotherapy through
C. Everett KoopCharles Everett Koop is an American pediatric surgeon and public health administrator. He was a vice admiral in the Public Health Service Commissioned Corps, and served as thirteenth Surgeon General of the United States under President Ronald Reagan from 1982 to 1989.-Early years:Koop was born in...
’s interest in the treatment. Mayo Clinic doctors list the areas that are most likely to benefit from prolotherapy treatment: ankles, knees, elbows, and sacroiliac joint in the low back. They report that "unlike
corticosteroidCorticosteroids are a class of steroid hormones that are produced in the adrenal cortex. Corticosteroids are involved in a wide range of physiologic systems such as stress response, immune response and regulation of inflammation, carbohydrate metabolism, protein catabolism, blood electrolyte...
injections — which may provide temporary relief — prolotherapy involves improving the injected tissue by stimulating tissue growth."
An
evidence-based medicineEvidence-based medicine aims to apply the best available evidence gained from the scientific method to medical decision making. It seeks to assess the quality of evidence of the risks and benefits of treatments ....
review of prolotherapy for
low back painLow back pain is a common symptom of musculoskeletal disorders or of disorders involving the lumbar vertebrae and related soft tissue structures such as muscles, ligaments, nerves and intervertebral discs. It can be either acute, subacute or chronic in its clinical presentation...
concluded: "There is conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-back pain. If used alone, prolotherapy injections do not have a role in the treatment of chronic low-back pain. When combined with other treatments, they may give prolonged partial relief of pain and disability."
History
Injections of irritant solutions were performed in the late 1800’s to repair hernias and in the early 1900’s for jaw pain due to temporomandibular (jaw) joint laxity. George S. Hackett developed the technique of prolotherapy in the 1940’s.
Gustav HemwallGustav Anders Hemwall was a physician at West Suburban Hospital in Oak Park, Illinois and pioneer in Prolotherapy. -Personal:...
was a pioneer, beginning his studies and treatments in the 1950s and continuing until the mid 1990s. In his study of almost 10,000 prolotherapy cases, Dr. Hackett found that over 99 percent of the patients found relief from their chronic pain.
Prolotherapy in clinical practice
Prolotherapy involves the injection of an irritant solution into the area where connective tissue has been weakened or damaged through injury or strain. Many solutions are used, including dextrose,
lidocaineLidocaine or lignocaine is a common local anesthetic and antiarrhythmic drug. Lidocaine is used topically to relieve itching, burning and pain from skin inflammations, injected as a dental anesthetic, and in minor surgery....
(a commonly used local anesthetic),
phenolPhenol, also known as carbolic acid, is a toxic, white crystalline solid. Its chemical formula is C6H5OH and its structure is that of a hydroxyl group bonded to a phenyl ring, making it an aromatic compound.-Phenols:...
, glycerine, or
cod liver oilCod liver oil is a nutritional supplement derived from liver of cod fish. It has high levels of the omega-3 fatty acids, EPA and DHA, and very high levels of vitamin A and vitamin D. It is widely taken to ease the symptoms of arthritis as well as other health benefits...
extract. The injection is given into joint capsules or where
tendonA tendon is a tough band of fibrous connective tissue that usually connects muscle to bone and is capable of withstanding tension. Tendons are similar to ligaments and fascia as they are all made of collagen except that ligaments join one bone to another bone, and fascia connect muscles to other...
connects to bone. Many points may require injection. The Injected solution causes the body to heal itself through the process of
inflammationInflammation is the complex biological response of vascular tissues to harmful stimuli, such as pathogens, damaged cells, or irritants. Inflammation is a protective attempt by the organism to remove the injurious stimuli as well as initiate the healing process for the tissue. Inflammation is not a...
and repair. In the case of weakened or torn connective tissue, induced inflammation and release of growth factor at the site of injury may result in a 30-40% strengthening of the attachment points, although strong scientific evidence supporting this is lacking.
Prolotherapy treatment sessions are generally given every two to six weeks. Many patients receive treatment at less and less frequent intervals until treatments are required only every several years, if at all.
Allen R Banks, Ph.D., has described in detail the theory behind prolotherapy in "A Rationale for Prolotherapy".
Guidelines used by practitioners as indicators for prolotherapy
- Recurrent swelling or fullness involving a joint or muscular region
- Popping, clicking, grinding, or catching sensations with movement
- A sensation of the “leg giving way” with associated back pain
- Temporary benefit from chiropractic manipulation or manual mobilization that fails to ultimately resolve the pain
- Distinct tender points and “jump signs” along the bone at tendon or ligament attachments
- Numbness, tingling, aching, or burning, referred into an upper or lower extremity
- Recurrent headache, face pain, jaw pain, ear pain
- Chest pain with tenderness along the rib attachments on the spine or along the front of the chest
- Spine pain that does not respond to surgery, or whose origin is not clear or consistent based on extensive studies
Evidence based medicine
A
Cochrane reviewThe Cochrane Collaboration is a group of over 10,000 volunteers in more than 90 countries who review the effects of health care interventions tested in biomedical randomized controlled trials. A few more recent reviews have also studied the results of non-randomized, observational studies...
of the medical literature as of January 2004 on the efficacy of prolotherapy injections in adults with chronic low-back pain found four controlled trials, all measuring pain and disability levels at six months. The review concluded:
- "There is conflicting evidence regarding the efficacy of prolotherapy injections in reducing pain and disability in patients with chronic low-back pain. Conclusions are confounded by clinical heterogeneity amongst studies and by the presence of co-interventions. There was no evidence that prolotherapy injections alone were more effective than control injections alone. However, in the presence of co-interventions, prolotherapy injections were more effective than control injections, more so when both injections and co-interventions were controlled concurrently."
The review also noted: "[m]inor side effects from the treatment, such as increased back pain and stiffness, were common but short-lived." ("Stiffness" is an expected short-lived side effect, as the goal is to cause irritation and the corresponding body reaction of temporary inflammation and repair.)
More recently, Rabago et al. [A systematic review of prolotherapy for chronic musculoskeletal pain. Clin J Sport Med. 2005 Sep;15(5):376-80] noted: "Two [randomized controlled trials] on osteoarthritis reported decreased pain, increased range of motion, and increased patellofemoral cartilage thickness after prolotherapy."
Criticism
Most major medical insurance policies do not cover the treatment. After a 1999 review of the medical evidence, Medicare declined to cover prolotherapy for chronic low back pain citing that prolotherapy "was last examined for coverage by the Health Care Financing Administration (HCFA) in September 1992".
Knee injuries
A randomized,
double-blindThe blind method is a part of the scientific method, used to prevent research outcomes from being influenced by either the placebo effect or the observer bias. To blind a person involved in research is to prevent them from knowing certain information about the process...
,
placeboA placebo is a sham medical intervention. In one common placebo procedure, a patient is given an inert sugar pill, told that it may improve his/her condition, but not told that it is in fact inert...
control study is currently recruiting patients to determine whether prolotherapy can decrease pain and disability from knee
osteoarthritisOsteoarthritis , is a group of diseases and mechanical abnormalities involving degradation of joints, including articular cartilage and the subchondral bone next to it...
. This study is Sponsored by the National Center for Complementary and Alternative Medicine (NCCAM).
Tennis elbow
A randomized,
double-blindThe blind method is a part of the scientific method, used to prevent research outcomes from being influenced by either the placebo effect or the observer bias. To blind a person involved in research is to prevent them from knowing certain information about the process...
,
placeboA placebo is a sham medical intervention. In one common placebo procedure, a patient is given an inert sugar pill, told that it may improve his/her condition, but not told that it is in fact inert...
control study is currently recruiting patients to determine whether prolotherapy can be an effective treatment for lateral epicondylitis (tennis elbow).
Thumb Joint Arthritis
A randomized,
double-blindThe blind method is a part of the scientific method, used to prevent research outcomes from being influenced by either the placebo effect or the observer bias. To blind a person involved in research is to prevent them from knowing certain information about the process...
,
placeboA placebo is a sham medical intervention. In one common placebo procedure, a patient is given an inert sugar pill, told that it may improve his/her condition, but not told that it is in fact inert...
control study is currently recruiting patients to compare prolotherapy to injection of corticosteroids in treating carpo-metacarpal joint arthritis of the thumb.
Plantar Fasciitis
Sonographically guided dextrose injections showed a good clinical response in patients with chronic plantar fasciitis insofar as reducing pain during rest and activity. Further studies including a control group are needed to validate these outcomes.
External links