Custom Pillow for Rotator Cuff Injury

Recruiting at 1 trial location

Overseen By Trevor Toavs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must not be taking: Corticosteroids

Disqualifiers: Prior shoulder surgery, Insomnia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a special pillow can improve sleep quality for those with shoulder pain from a rotator cuff injury. The treatment under evaluation is the MedCline Shoulder Relief System, designed to offer comfort and support during sleep. Participants will either use this pillow or maintain their regular sleeping habits to compare outcomes. Ideal candidates have a diagnosis of rotator cuff syndrome and are not undergoing surgery. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for enhancing sleep quality without surgery.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the MedCline Shoulder Relief System is safe for patients with rotator cuff injury?

Research shows that the MedCline Shoulder Relief System is designed to alleviate shoulder pain, including issues like rotator cuff injuries. This special pillow reduces pressure on the shoulder and arm during sleep. While specific studies on its safety are lacking, it is important to note that as a pillow, not a medication or surgical tool, it generally poses low risk.

Many users report better sleep with this pillow, with 95% experiencing improved rest. Its unique design includes a special arm pocket to enhance comfort for side sleepers, suggesting it is well-tolerated. However, consult a doctor if there are concerns about using new products for pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for rotator cuff injuries, which often involve physical therapy, medications, or even surgery, the MedCline Shoulder Relief System is a specially designed pillow that aims to provide relief by improving sleep posture. This system is unique because it offers a non-invasive, drug-free option that targets discomfort during sleep, a common issue for those with shoulder injuries. Researchers are excited about this approach because it has the potential to enhance comfort and reduce pain without the side effects associated with medications or the recovery time linked to surgical procedures.

What evidence suggests that the MedCline Shoulder Relief System is effective for improving sleep quality in patients with rotator cuff injury?

Research has shown that the MedCline Shoulder Relief System can greatly improve sleep for people with shoulder pain. About 95% of users report better sleep with it. In this trial, participants in the experimental arm will receive the MedCline Shoulder Relief System pillow, designed to reduce pressure on the shoulder and arm, easing pain from issues like tendonitis, bursitis, and rotator cuff injuries. Its gentle slope lessens pain and increases comfort. Many users have found it helpful for managing shoulder pain and improving sleep quality. ^{2 6 7 8 9}

Who Is on the Research Team?

E S Paxton, MD

Principal Investigator

University Orthopedics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with shoulder pain from non-operatively treated rotator cuff syndrome. It's not suitable for those who can't sleep on their side, have no mailing address, don't speak English, suffer from obstructive sleep apnea, had previous shoulder surgery or clinical insomnia.

Exclusion Criteria

I have obstructive sleep apnea.

I have had shoulder surgery in the past.

I am getting a corticosteroid shot at my first visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MedCline Shoulder Relief System pillow or no pillow, with both groups following the same physical therapy protocols

6 weeks

Baseline, 2 weeks, 6 weeks

Follow-up

Participants are monitored for changes in quality of life, shoulder function, and sleep difficulty

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MedCline Shoulder Relief System

Trial Overview

The study tests if the MedCline Shoulder Relief System, a custom pillow designed to aid sleep, can improve the quality of sleep for patients suffering from shoulder pain due to rotator cuff injuries.

How Is the Trial Designed?

Group I: MedCline Shoulder Relief System Experimental Treatment 1 Intervention

Patients who will receive the MedCline Shoulder Relief System pillow

Group II: Control Active Control 1 Intervention

Patients who will not receive the MedCline Shoulder Relief System pillow

MedCline Shoulder Relief System is already approved in United States for the following indications:

Approved in United States as MedCline Shoulder Relief System for:

• Rotator cuff injuries
• Shoulder arthritis
• Bursitis
• Tendonitis
• General shoulder pain
• Post-operative positioning

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Amenity Health, Inc.

Industry Sponsor

Trials

3

Recruited

120+

Published Research Related to This Trial

In a study of 391 patients with rotator cuff disease, 91% reported nocturnal pain, which was significantly correlated with poor sleep quality, depression, and other health factors like high body mass index and diabetes.

Interestingly, the severity of rotator cuff pathology did not directly correlate with worse sleep quality, suggesting that factors like pain and depression may play a more critical role in sleep disturbances than the actual severity of the shoulder condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Quality in Patients With Rotator Cuff Disease. Khazzam, MS., Mulligan, EP., Brunette-Christiansen, M., et al.[2019]

Patients with rotator cuff disease often experience poor-quality sleep, which can negatively impact their daily life and overall health due to its effects on biological functions and cognitive processes.

The causes of nocturnal shoulder pain in these patients are complex and may involve high levels of inflammatory factors and various personal and medical variables, making it difficult to determine the impact of rotator cuff repair surgery on sleep quality improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Sleep Disorders in Rotator Cuff Diseases. Longo, UG.[2022]

In a study of 209 patients with unilateral full-thickness rotator cuff tears, no significant correlation was found between the size or characteristics of the tears and the level of sleep disturbance, as measured by the Pittsburgh Sleep Quality Index.

The only significant finding was that tendon retraction correlated with shoulder pain levels, suggesting that while rotator cuff tears can cause nocturnal pain, their physical characteristics may not directly impact sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Magnetic Resonance Imaging Characteristics of Full-Thickness Rotator Cuff Tears Correlate With Sleep Disturbance? Reyes, BA., Hull, BR., Kurth, AB., et al.[2022]

In a study of 343 patients with shoulder disorders, those diagnosed with adhesive capsulitis (AC) reported significantly poorer sleep quality compared to other conditions, with a mean Pittsburgh Sleep Quality Index score of 12.07.

Despite similar pain levels across different shoulder disorders, patients with AC had lower functional scores, indicating that AC not only affects sleep but also overall shoulder function more severely than subacromial impingement syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep quality and nocturnal pain in patients with shoulder disorders. Mulligan, EP., Brunette, M., Shirley, Z., et al.[2022]

The choice of immobilization device and arm positioning after arthroscopic rotator cuff repair may influence postoperative pain and healing outcomes, although current evidence is not definitive.

There is a need for further research to generate meaningful evidence that can improve patient care and manage healthcare costs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Better Care, Better Health, Better Cost: Is Scientific Evidence Negatively Impacting the Transformation of Health Care? Plancher, KD.[2019]

In a study of 252 individuals with rotator cuff related shoulder pain (RCRSP), those who experienced pain onset above 120° of arm elevation reported better upper limb functioning, as measured by the DASH questionnaire, compared to those with pain onset between 60°-120°.

Demographic factors such as male sex, younger age, non-dominant side affected, and longer duration of symptoms were found to contribute to better functioning, explaining 31% of the variance in DASH scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the angular onset of pain during arm elevation associated to functioning in individuals with rotator cuff related shoulder pain? Noés, GR., Haik, MN., Pott-Junior, H., et al.[2022]

In a cadaver study examining rotator cuff repairs, it was found that arm position significantly affects the tension in the repair, especially with small tears, where moving from 30 degrees to 15 degrees of abduction increased tension substantially.

Capsular release was shown to reduce the force on the repair, particularly at 0 degrees and 15 degrees of abduction, indicating that this surgical technique may impact the stability of rotator cuff repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of arm position and capsular release on rotator cuff repair. A biomechanical study. Zuckerman, JD., Leblanc, JM., Choueka, J., et al.[2021]

Rotator cuff injuries are associated with significant nighttime pain, affecting 91-93% of patients, with an average pain intensity of 5.5 on a scale, which severely impacts sleep quality.

After treatment, patients experience a notable reduction in pain (to scores below 2) and improvements in sleep quality, indicating that effective repair of rotator cuff injuries can enhance overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rotator cuff injuries with nighttime pain and sleep quality before and after treatment]. Castro-Contreras, E., Valdez-Pardo, ME.[2022]

Citations

1.

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Medcline LP Shoulder Relief System

MedCline Shoulder Relief System is designed to remove pressure from a patient's downside arm and shoulder for pain relief from nighttime chronic shoulder pain.

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Medcline LP Shoulder Relief System

MedCline Shoulder Relief System is designed to remove pressure from a patient's downside arm and shoulder for pain relief from nighttime chronic shoulder pain.

9.

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