MedCline Shoulder Relief System for Rotator Cuff Tears

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Orthopedics, Riverside, RI
Rotator Cuff Tears
MedCline Shoulder Relief System - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a pillow sleep aid improves sleep quality in the short term for patients who have shoulder pain from a rotator cuff injury and are being managed non-operatively.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether MedCline Shoulder Relief System will improve 6 primary outcomes in patients with Rotator Cuff Tears. Measurement will happen over the course of Baseline, two weeks, six weeks.

Baseline, two weeks, six weeks
Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
Change in Quality of Life as Assessed Using the Euroqol (EQ-5D)
Change in Shoulder Function as Assessed Using the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Change in Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE)
Change in Shoulder Function as Assessed Using the Western Ontario Rotator Cuff Index (WORC)
Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
MedCline Shoulder Relief System
1 of 2
Active Control
Experimental Treatment

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. MedCline Shoulder Relief System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

MedCline Shoulder Relief System
Device
Patients who will receive the MedCline Shoulder Relief System pillow
Control
Device
Patients who will not receive the MedCline Shoulder Relief System pillow

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, two weeks, six weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, two weeks, six weeks for reporting.

Closest Location

University Orthopedics - Riverside, RI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
age >18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively.

Patient Q&A Section

What are the signs of rotator cuff tears?

"Data from a recent study of the study suggest that the presence of an underlying pathologic process is likely to be part of the syndrome." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating rotator cuff tears?

"There have been more new discoveries for treating rotator cuff tears, with new and better implants and treatments; these may help us manage and treat rotator cuff tears." - Anonymous Online Contributor

Unverified Answer

Is medcline shoulder relief system safe for people?

"If properly fitting, the Medcline shoulder relief system is as safe as standard arthroscopic shoulder surgery that has been reported to result in similar improvement of function, pain relief, and return to pre-surgery activity." - Anonymous Online Contributor

Unverified Answer

Has medcline shoulder relief system proven to be more effective than a placebo?

"Patients who have undergone surgery for chronic shoulder pain with moderate shoulder function will generally benefit from the use of the [medCLINES] RS. Therefore, using the RS as a primary care treatment for shoulder pain is an innovative practice that will complement standard of care." - Anonymous Online Contributor

Unverified Answer

What causes rotator cuff tears?

"A combination of shoulder position during activities such as overhead sports and muscular strength are significant factors. Furthermore, external factors such as external compression can also be contributory." - Anonymous Online Contributor

Unverified Answer

What are common treatments for rotator cuff tears?

"Results from a recent clinical trial determined that shoulder arthroscopy and arthrolysis were the treatments most commonly used in managing rotator cuff tears. The data suggest that there is a significant shortage of surgeons practicing in rotator cuff repair. Therefore, future educational programs and research should be aimed at the surgical training of new arthroscopic rotator cuff repair surgeons and at the use of rotator cuff arthroscopy as a primary surgical strategy for treating rotator cuff tears." - Anonymous Online Contributor

Unverified Answer

What is rotator cuff tears?

"Most patients will have mild symptoms and signs of a rotator cuff tear, but rarely will require surgical intervention. Tear of the supraspinatus tendon is associated with impaired external rotation and is likely to be a result of a posterolateral rotational tear." - Anonymous Online Contributor

Unverified Answer

Can rotator cuff tears be cured?

"There is no evidence that rotator cuff tendon-to-bone repair can be accomplished reliably or safely in the short-term. However, because repair with autograft or allograft tissue is more likely to replicate the natural repair mechanism of the rotator cuff, this technique of repair appears to offer a reasonable option for patients with small tears." - Anonymous Online Contributor

Unverified Answer

How many people get rotator cuff tears a year in the United States?

"There are an estimated 50,000-60,000 rotator cuff tears annually in the US. rotator cuff tears: are associated with significant pain, disability, and greater healthcare utilization. Increased awareness of the diagnosis would decrease the magnitude of this burden." - Anonymous Online Contributor

Unverified Answer

Does rotator cuff tears run in families?

"This is the first study to link the risk to developing rotator cuff tears to family history to tear in the same position. In a recent study, findings have important management implications and may have significant implications during the decision-making processes for patients." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets rotator cuff tears?

"There is no standard age of onset. Most report onset between 30-50 years. There is variation of reporting based on gender and BMI. It has been reported that 20% of rotator cuff tear patients do not achieve a normal strength with manual maneuvers. It appears that women, especially older women, tend to be the ones to suffer from rotator cuff tears as early as their 20s or even 25s. For older women, rotator cuff tears are not the cause of their pain or difficulty with movement anymore." - Anonymous Online Contributor

Unverified Answer

Is medcline shoulder relief system typically used in combination with any other treatments?

"The MCR system was most commonly used in combination with at least one other treatments. The authors suggest the need to develop an efficient clinical guide when managing the patients with severe shoulder pain who underwent MCR and other treatments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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