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Active PEMF for Rotator Cuff Tears (RCStim Trial)

Q: In which Canadian locations is this scientific study being conducted?

<p>Rush University Medical Center in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>, Coastal Orthopedics and Sports Medicine in Bradenton, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>, Cincinnati Sports Medicine in Cincinnati are just some of the 24 medical sites currently participating this clinical trial.</p>

N/A

Waitlist Available

Research Sponsored by Orthofix Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

RCStim Trial Summary

This trial will study the effects of a pulsed electromagnetic field on people who have had surgery to repair a full thickness rotator cuff tear. The hypothesis is that the electromagnetic field will reduce the rate of re-tears. The study will also measure the strength of the shoulder muscles and the levels of pain in subjects after repair.

Eligible Conditions

Rotator Cuff Tear

RCStim Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

retear rate

Secondary outcome measures

Muscle Strength

Penn Shoulder Score

RCStim Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active PEMFActive Control1 Intervention

Subjects have 2 out of 3 chance to get the active device which emits a pulsed electromagnetic field (PEMF) from the RCStim Model 1114 device (right and left side models available). Double-blind randomization.

Group II: Control/placebo PEMFPlacebo Group1 Intervention

Subjects have a 1 out of 3 chance to get the control/placebo device which does not emit a pulsed electromagnetic field (PEMF) from the RCStim Model 1114 device (right and left side models available). Double-blind randomization.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Orthofix Inc.Lead Sponsor

15 Previous Clinical Trials

6,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for me to participate in this experiment?

"This clinical trial seeks 377 participants aged 21-80 who possess lipocalin 1. Additionally, these individuals must not have utilized nonsteroidal anti-inflammatory drugs in the week prior to surgery and may not be undergoing concurrent fracture repairs or reconstructions. Moreover, they are allowed to have previously undergone teres minor/subscapularis muscle repair, acromioplasties and decompressions as well as biceps tenodesis/tenotomy (open or closed)."

Answered by AI

Does this study permit the enrollment of individuals aged 55 and above?

"The participant eligibility criteria necessitates that individuals must be over 21 years old and not exceed 80 in age."

Answered by AI

In which Canadian locations is this scientific study being conducted?

"Rush University Medical Center in Chicago, Illinois, Coastal Orthopedics and Sports Medicine in Bradenton, Ohio, Cincinnati Sports Medicine in Cincinnati are just some of the 24 medical sites currently participating this clinical trial."

Answered by AI

Are there still openings available for people to participate in this trial?

"According to the clinicaltrials.gov page, this particular trial is no longer actively recruiting patients; it was initially posted on January 15th 2018 and last edited on December 1st 2022. However, 105 other studies are still enrolling hopeful participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears

2018. "PEMF as Adjunctive Treatment Following Surgical Repair of Full Thickness Rotator Cuff Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03339492.