Research

By Michael Carroll, M.D., family physician and inventor of the Shoulder Reliever

The short answer

In a 2006 randomized trial, every patient with rotator cuff tendinopathy who wore our nighttime brace for 28 days improved, compared with about half of patients who did not. The study was presented at the American College of Sports Medicine (ACSM) annual meeting and published as an abstract in Medicine & Science in Sports & Exercise.

The study

  • Title: A Randomized Trial to Assess the Efficacy of Nighttime Bracing for Rotator Cuff Tendinopathy
  • Authors: Michael Carroll, M.D. (Creekside Clinic, Traverse City, MI) and Thomas Best, M.D., FACSM (The Ohio State University)
  • Presented: ACSM 53rd Annual Meeting, Denver, Colorado, June 2006
  • Published: abstract in the May 2006 supplement of Medicine & Science in Sports & Exercise
  • Oversight: approved by the institutional review board (IRB) at Munson Medical Center and run by an independent clinical research organization. Patients were referred by primary care physicians with no financial interest in the device.

How it worked

23 adults aged 25 to 65 with rotator cuff tendinopathy, at least one month of shoulder pain, and pain at night were randomly assigned to one of two groups for 28 days:

  • Brace group (11 patients): wore a nighttime brace that keeps the arm at the side, limiting it to 5 degrees of movement away from the body.
  • No-brace group (12 patients): no brace.

Both groups kept their usual care, including a home or formal physical therapy program and their regular medications. No one received a steroid injection during the study. Shoulder function was measured with the Simple Shoulder Test, a standard 12-question score of everyday activities, at day 0, day 7 and day 28.

What we found

  • All 11 patients in the brace group improved.
  • 64% of the brace group improved their score by at least 25%.
  • Half of the no-brace group (6 of 12) reported no improvement.
  • The brace group improved significantly more than the no-brace group at 28 days (p < 0.05).
  • Medication use and physical therapy compliance were the same in both groups.

Why the nighttime brace helps

When you stand, the weight of your arm gently opens the space in the shoulder joint. When you lie down, you lose that pull, and when the arm drifts away from the body during sleep, the top of the arm bone moves closer to the bony roof of the shoulder and pinches the rotator cuff tendon. Night after night, that pinching keeps the tendon irritated. Keeping the arm at your side while you sleep prevents it, giving the tendon a chance to calm down and heal.

What this study does and doesn't show

Early on, we only tested the nighttime component. The study used the original nighttime brace, before we added the daytime exercise trainer that is now part of the Shoulder Reliever. It was also small, it followed patients for 28 days, and I own the patent on the device, which we disclosed with the study.

We have an upcoming clinical trial testing both components: the nighttime bracing and the daytime exercise. We are very excited for those results to come out and be published, and we will share them here.

Read more

Individual results vary. The Shoulder Reliever is not a substitute for medical care; if you have a shoulder injury, talk with your doctor.