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

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine if 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.

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 data supports the effectiveness of the treatment MedCline Shoulder Relief System for rotator cuff injuries?

The research highlights that shoulder injuries, including rotator cuff issues, often lead to severe pain and poor sleep quality. While specific data on the MedCline Shoulder Relief System is not provided, improving sleep quality and reducing nighttime pain are important for managing rotator cuff injuries, suggesting that a treatment focusing on these aspects could be beneficial. ^{1 2 3 4 5}

How is the MedCline Shoulder Relief System treatment different from other treatments for rotator cuff injury?

The MedCline Shoulder Relief System is unique because it is designed to improve sleep quality by addressing nocturnal shoulder pain, which is a common issue for patients with rotator cuff injuries. Unlike other treatments that may focus on pain relief or physical therapy, this system specifically targets sleep disturbances by providing a supportive sleeping position to reduce pressure on the shoulder. ^{2 5 6 7 8}

Research Team

E S Paxton, MD

Principal Investigator

University Orthopedics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

References

1. Brazil 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? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep quality and nocturnal pain in patients with shoulder disorders. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

The effect of arm position and capsular release on rotator cuff repair. A biomechanical study. [2021]

5. Mexico pubmed.ncbi.nlm.nih.gov

[Rotator cuff injuries with nighttime pain and sleep quality before and after treatment]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sleep Quality in Patients With Rotator Cuff Disease. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Do Magnetic Resonance Imaging Characteristics of Full-Thickness Rotator Cuff Tears Correlate With Sleep Disturbance? [2022]