The Benefits of Participating in Clinical Trials

Being part of a study "benefits you while also benefitting others who may be helped by what the researchers learn," explains Ellen Meltzer, who is participating in a five-year clinical trial of an investigational shoulder therapy device led by Dr. Ronald Delanois, chairman of orthopedics at the Rubin Institute for Advanced Orthopedics (RIAO).

Meltzer adds, "When you are part of a study, you have another team of people keeping an eye on you, so you receive extra attention. The study may include more frequent check-ins with the healthcare professionals, as well as additional tests, scans or therapy sessions, so you know more about your condition. I would think that everyone would want to participate."

Meltzer is part of a study looking at the safety and effectiveness of a device using pulsed electromagnetic field (PEMF) therapy as an adjunctive therapy with the surgical repair of certain rotator cuff tears. PEMF devices use low field magnetic stimulation to try to stimulate healing. RIAO is one of a select few research centers across the United States taking part in this particular investigation, which is enrolling approximately 538 patients nationwide.

For the study, participants wear the PEMF shoulder device for 90 minutes a day for six months. The device uses Bluetooth technology to connect to an iPad or smart phone to keep track of the usage time and other measurements. 

After the initial six months, there are follow-up visits over the next several years of the study, including MRIs, to see if there are improvements or changes in the shoulder. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment.

Although Meltzer does not know whether she received the actual treatment or a placebo, she says that she is happy to be part of this research that may help others. 

Reflecting on her own experience, Meltzer says, "While you need to make a commitment to follow the study protocol, it's been very easy to be part of this study. It's wonderful to know that you are doing something to help researchers learn and that could help patients in the future."

To learn more about RIAO's Clinical Research Division, visit the team's research page or email RIAOResearch@lifebridgehealth.org. You can also learn more about this study by visiting: https://clinicaltrials.gov/ct2/show/NCT03339492