DENVER — A simple device seems to ease nighttime shoulder pain, according to study findings presented at the annual meeting of the American College of Sports Medicine.
Dr. Michael Carroll, a Traverse City, Mich.-based family physician in private practice, presented independent research on the device, called the NyteTyme Shoulder Immobilizer. The data showed improvement in all of the patients who used the device for 28 days, whereas more than half of the patients who did not use it reported worsening or no improvement in their shoulder pain.
The device consists of a thigh sleeve and a wrist sleeve connected by an elastic strap. Its design is aimed at keeping the arm adducted, limiting abduction to 5 degrees and providing a variable amount of traction.
The controlled study involved 24 patients diagnosed by their primary care physicians with rotator cuff tendinopathy. A randomly selected group of 11 patients wore the device nightly for 28 days, and the remaining 13 patients did not. All patients continued their regular treatments during the study. Most were taking nonsteroidal anti-inflammatories, and several were also doing physical therapy.
Patients were excluded from the study if they had a recent history of shoulder or neck trauma, a history of deep vein thrombosis, or a history of cancer except for nonmelanoma skin cancer. None of the patients received steroid injections during the course of the study.
Investigators administered the standardized Simple Shoulder Test (SST), a 12-item test that assesses shoulder symptoms, at day 0, day 7, and day 28.
Of the patients using the device, 100% reported improvements on the SST, compared with only 47% of the patients in the control group, a statistically significant difference.
Dr. Carroll owns a patent on the device, as well as the company that manufactures it, but the study was conducted by an independent clinical research organization after approval by an institutional review board based at Munson Medical Center, Traverse City, and the patients were referred by primary care physicians with no financial interest in the device.
Shoulder pain is extremely common, ranking third behind back and neck pain as a cause of dysfunction in the working population, Dr. Carroll noted. One study showed that 30% of the population experiences shoulder pain during any given 12-month period. Another study showed that partial rotator-cuff tears can be found in autopsy in 32%–37% of individuals above the age of 40.
Rotator cuff tendinopathy is typically treated with nonsteroidal anti-inflammatory drugs and physical therapy, but even compliant patients can experience a worsening of their pain and eventually require surgery.
Two nighttime factors contribute to supraspinatus tendon impingement and can therefore lead to further injury of the rotator cuff.
The first factor is that when patients lie down, they lose the traction of the weight of the arm that gravity normally provides when upright. The second factor is that abduction of the arms away from the body can cause the humeral head to move closer to the coracoacromial ligament, further impinging the supraspinatus tendon. Keeping the arm adducted, prevents additional injury and promotes healing.
Dr. Carroll said the device is available through a single supplier, Teter Orthotics and Prosthetics Inc. (www.teterop.com