Rotator Cuff InjuriesNCT05011331
The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome
A study testing MedCline Shoulder Relief System in people with Rotator Cuff Injuries, run by Rhode Island Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- MedCline Shoulder Relief System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively.
Who cannot join
- history of prior shoulder surgery, receiving a corticosteroid injection at initial visit, lack of mailing address, non-English speaking patient, inability to sleep on one's side, preexisting clinical insomnia and obstructive sleep apnea.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Orthopedics
East Providence, Rhode Island, 02915
Trevor Toavs, (401)443-4278, ttoavs@universityorthopedics.com
About this study
Official title: The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome: a Prospective Randomized Study
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.
Read the detailed description
Patients who have shoulder pain from a rotator cuff injury will be identified in the outpatient clinic and offered the chance to enroll in the study. Informed consent will be obtained. There will be two groups of patients in this study; those that receive the pillow sleep aid (the intervention group) and those that do not (the control group). The pillow sleep aid that will be investigated in this project is the "MedCline Shoulder Relief System," a product of Amenity Health Inc.. The pillow will be delivered to the intervention group at no cost. Patients in both groups will be prescribed the same physical therapy protocols. At the end of the trial period, patients in the control group will be offered the option to receive a pillow. Those that accept will be surveyed at similar intervals as the original intervention group.
- Conditions
- Rotator Cuff Injuries
- Being tested
- MedCline Shoulder Relief System
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedCline Shoulder Relief SystemDevice
Patients will receive a customized pillow to aid with sleep
| Study group | Role | What they receive |
|---|---|---|
| MedCline Shoulder Relief System | Experimental | Patients who will receive the MedCline Shoulder Relief System pillow Receives: Device: MedCline Shoulder Relief System |
| Control | Active comparator | Patients who will not receive the MedCline Shoulder Relief System pillow Receives: Device: MedCline Shoulder Relief System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)
The ISI assesses sleep difficulty using a 5 point Likert Scale, where a lower score is better
Measured: Baseline, two weeks, six weeks
Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
The VAS utilizes a scale from 0-10 where a high score indicates more pain
Measured: Baseline, two weeks, six weeks
Change in Quality of Life as Assessed Using the Euroqol (EQ-5D)
The EQ-5D assesses quality of life with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: Baseline, two weeks, six weeks
Change in Shoulder Function as Assessed Using the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is a pain scale worth 50 points and ten activities of daily living questions worth 50 points
Measured: Baseline, two weeks, six weeks
Change in Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE)
SANE assesses shoulder function via 1 question as a percentage of normal (0-100 scale with 100 being normal)
Measured: Baseline, two weeks, six weeks
Change in Shoulder Function as Assessed Using the Western Ontario Rotator Cuff Index (WORC)
WORC utilizes 21 questions where each question uses a visual analog scale, a line with a 0-100 scale where 0 represents no difficulty. It asks about shoulder pain in 5 different domains, physical symptoms, sports, work, social, and emotions
Measured: Baseline, two weeks, six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start13 Oct 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amenity Health, Inc.
- Responsible party
- Sponsor
- Investigators
- E S Paxton, MD, Principal investigator, University Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011331
- Sponsor's protocol ID
- 1620695
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2021
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05011331
- Acronym / sponsor ID
- 1620695
- Conditions
- Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Amenity Health, Inc.
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who have shoulder pain from a rotator cuff injury will be identified in the outpatient clinic and offered the chance to enroll in the study. Informed consent will be obtained. There will be two groups of patients in this study; those that receive the pillow sleep aid (the intervention group) and those that do not (the control group). The pillow sleep aid that will be investigated in this project is the "MedCline Shoulder Relief System," a product of Amenity Health Inc.. The pillow will be delivered to the intervention group at no cost. Patients in both groups will be prescribed the same physical therapy protocols. At the end of the trial period, patients in the control group will be offered the option to receive a pillow. Those that accept will be surveyed at similar intervals as the original intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MedCline Shoulder Relief System | Experimental | Device: MedCline Shoulder Relief SystemPatients who will receive the MedCline Shoulder Relief System pillow |
| Control | Active comparator | Device: MedCline Shoulder Relief SystemPatients who will not receive the MedCline Shoulder Relief System pillow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age >18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively.
Key exclusion criteria (1 listed)
- history of prior shoulder surgery, receiving a corticosteroid injection at initial visit, lack of mailing address, non-English speaking patient, inability to sleep on one's side, preexisting clinical insomnia and obstructive sleep apnea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedCline Shoulder Relief SystemPatients will receive a customized pillow to aid with sleep | Device | Control, MedCline Shoulder Relief System |
Primary outcome
Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI)
Time frame: Baseline, two weeks, six weeks
The ISI assesses sleep difficulty using a 5 point Likert Scale, where a lower score is better
Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
Time frame: Baseline, two weeks, six weeks
The VAS utilizes a scale from 0-10 where a high score indicates more pain
Change in Quality of Life as Assessed Using the Euroqol (EQ-5D)
Time frame: Baseline, two weeks, six weeks
The EQ-5D assesses quality of life with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Change in Shoulder Function as Assessed Using the American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: Baseline, two weeks, six weeks
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is a pain scale worth 50 points and ten activities of daily living questions worth 50 points
Change in Shoulder Function as Assessed Using the Single Assessment Numeric Evaluation (SANE)
Time frame: Baseline, two weeks, six weeks
SANE assesses shoulder function via 1 question as a percentage of normal (0-100 scale with 100 being normal)
Change in Shoulder Function as Assessed Using the Western Ontario Rotator Cuff Index (WORC)
Time frame: Baseline, two weeks, six weeks
WORC utilizes 21 questions where each question uses a visual analog scale, a line with a 0-100 scale where 0 represents no difficulty. It asks about shoulder pain in 5 different domains, physical symptoms, sports, work, social, and emotions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
E S Paxton, MD principal investigator
University Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedCline Shoulder Relief System in people with Rotator Cuff Injuries, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trevor Toavs ((401) 457-1500 ext. 4278, ttoavs@universityorthopedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Difficulty as Assessed as Assessed Using the Insomnia Severity Index (ISI) (time frame: Baseline, two weeks, six weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.