We are searching for individuals between the ages of 25-70 who are experiencing elbow pain to participate in a clinical study. Our study involves the assessment and treatment of chronic (6 months or longer) Lateral Epicondylitis (Tennis Elbow) and/or chronic Medial Epicondylitis (Golfer’s Elbow) also known as Tendinosis/Tendinitis. Common symptoms include:
- Pain in the elbow region when using either the extensor or flexor muscles of the forearm.
- Point tenderness of either lateral or medial elbow
- Weakened grip strength
- Reduced athletic ability due to elbow pain or expectant elbow pain
- Guarded use of the arm due to expectant elbow pain
Our study is being performed so that we can measure the efficacy and healing time of chronic medial and/ or lateral epicondylitis using allograft therapy.
For the purposes of this study we will use the following definitions:
- Epicondylitis is a condition of the elbow.
- The term Chronic Epicondylitis is used to describe soft-tissue conditions characterized by pain of (at least) 6 month duration in the region of the epicondyle. The pain is exacerbated by use of either the extensor or flexor muscles of the forearm.
- Lateral Epicondylitis (Tennis Elbow) is a term used to describe a soft-tissue condition characterized by pain of (at least) 6 month duration and point tenderness in the region of the lateral epicondyle. It is the result of degenerative tendinosis of the extensor carpi radialis brevis muscle.
- Medial Epicondylitis (Golfer’s Elbow) is a term used to describe a soft-tissue condition characterized by pain of (at least) 6 month duration and point tenderness in the region of the medial condyle. It is the result of degenerative tendinosis of the pronator teres and flexor carpi radialis muscles.
If you are interested in taking part in our study, our doctors will examine your injury at no-cost. If you qualify for the study, you will begin care.
To be included in the study, participants will have a positive orthopedic test for Lateral or Medial epichondylitis.
The test for Lateral Epicondylitis is Cozen’s test, which consists of pronation of the forearm with resisted wrist extension and radial deviation to determine if pain occurs. The test for Medial Epicondylitis is a clinical test in which pain is exacerbated on resisted pronation of the forearm with wrist flexion.
X-rays are frequently normal, but they will be used to exclude pathology such as osteomyelitis, bone spurs, and intra-articular pathology.
Occupations and activities known to cause and/or aggravate Lateral Epicondylitis include, but are not limited to, the following:
- racquet sports, including tennis
- throwing sports
- lifting and throwing snow
- construction workers
- boiler makers
- butchers/meat packers
- sign language interpreters
Occupations and activities known to cause and/or aggravate Medial Epicondylitis include, but are not limited to, the following:
- racquet sports
- pitching in baseball
- throwing sports
- carrying a heavy suitcase
Most cases of tennis elbow respond to rest, ice, rehab exercises, pain medicine, and counterforce braces such as an elbow strap. This injury does take from 6 months to 12 months to heal. Rest means, for instance, that a chef has to stop the aggravating repetitive use of arm and elbow-using a knife, blending, mixing etc. For an athlete, rest means taking 6 to 12 months off of the aggravating sport and training involving the elbow joint. This standard treatment protocol takes patience and if the person returns to the aggravating activity to soon re-injury is expected. Surgery is considered as a last resort when all other nonsurgical treatments have failed. This study is designed to find out if allograft injection is an effective way to decrease the time to heal these debilitating and painful conditions.
Allografts are a safe, non-surgical injection therapy being used an alternative to surgery for this and many other forms of skeletal joint dysfunction.
Amniotic allografts are minimally manipulated amniotic tissues, donated by fully consenting mothers who had a full-term live delivery via Cesarean section. To decrease the risk of transmitting an infection, all donated tissues must meet strict specifications during the laboratory screening and testing. All allografts have been obtained and processed in the United States according to the regulations and principles recognized by the American Association of Tissue Banks (AATB) and the United States Food & Drug Association (FDA).
Amniotic allograft injections have been shown to provide tremendous improvement in the treatment of chronic soft tissue conditions. These long- lasting treatments allow the patient to recover much more quickly and reduce the down time associated with surgery. We encourage our participants to enroll in this exciting and beneficial study so that they may return to being able to enjoy more active, pain-free lives again.