Rotator Cuff TearsNCT06669741
Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear
A study testing Shoulder Sleeve in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Texas Bone and Joint at 1 site in United States.
Trial summary
To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Arthropathy of Left Shoulder (Disorder)
- What is being tested?
- Shoulder Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 2 Dec 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing arthroscopic rotator cuff repair
- Patients aged 18-75
- Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- Patients who are willing and able to sign corresponding research subject consent form.
Who cannot join
- Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- Patient has had prior surgical treatment of a shoulder injury in the past 5 years
- Patient has chronic pain conditions unrelated to shoulder condition
- Patient has auto-immune or auto-inflammatory diseases
- Patient has used tobacco within the last 90 days
Show all 13Show fewer
- Patient is not within the ages of 18-75
- Patient has poorly controlled diabetes with HgA1c > 7.5
- Patient has an active infection (local or systemic)
- Patient is unwilling or unable to sign the corresponding research subject consent form
- Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
- Against medical advice (AMA)
- Prisoner as indicated in the medical record
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Semiconductor Embedded Therapeutic Garments From Incrediwear
To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling.
Read the detailed description
Study Screening/pre-operative appointment
- The surgeon confirms the participant meets the inclusion criteria and is scheduled for surgery in the next few weeks.
- The surgeon will discuss the study and possible risks/benefits of being in the research.
- The study team will measure the participant wrist, arm, and shoulder circumference.
- The participant will rate their shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; shoulder function with the American Shoulder and Elbow Surgeons Score (ASES) scale, and function limitations using the Western Ontario Rotator Cuff Index (WORC) questionnaire.
- The study team will measure the patient's shoulder's range of motion, stability, and strength.
- Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure.
- Day of Surgery
- A study packet will be given to the participant by the study staff. The packet will include a study number assignment, the products assigned, and the patient study journal. The participant, surgeon, and clinical staff will not know which group the participant is in.
- After surgery, the surgeon and PI, Dr. Flowers, will place the shoulder brace and arm sleeve according to the random assignment in the study packet. An abduction sling will then be placed on top of the shoulder brace and arm sleeve by Dr. Flowers.
- Participant will be instructed to wear the shoulder brace and arm sleeve for at least 20 hours per day, including overnight, for 12 weeks post-surgery.
- Participant will be instructed on the length of time to wear the shoulder abduction sling by the surgeon.
- The clinical staff will take arm circumference measurements post-surgery.
- Postoperative Recovery: Weeks 1-12
- Follow-up visits will be at 2 weeks, 6 weeks, and 12 weeks post-surgery. During follow-up visits:
- The clinical staff will take arm swelling measurements.
- Participant shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons score (ASES), and Western Ontario Rotator Cuff Index (WORC) questionnaires.
- The clinical staff will measure shoulder's range of motion, stability, and strength.
- Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure.
- Daily reported measures include:
- Participant will record pain medication type and quantity taken in a medications log. Only medications related to the treatment of shoulder pain or function will be required to be reported.
- Participant will rate shoulder pain severity on a 1-10 VAS in a pain diary log.
- Participant will record how long they have worn the shoulder brace and arm sleeve in device usage log.
- At the 12th week follow-up visit all study products, including the shoulder brace, arm sleeve, medications log, pain diary log, and device usage log.
- Postoperative Recovery: 6 months and 1 year post surgery
- A follow-up phone call after 6 months and 1-year post-surgery will be administered.
- Participant will be asked to rate shoulder pain on a 1-10 Visual Analog Scale (VAS) and shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons score (ASES), and Western Ontario Rotator Cuff Index (WORC) questionnaires.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Arthropathy of Left Shoulder (Disorder), Rotator Cuff Arthropathy of Right Shoulder (Disorder), Rotator Cuff Arthropathy of Bilateral Shoulders
- Being tested
- Placebo, Shoulder Sleeve
- 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.
PlaceboDevice
One group will receive placebo therapy (identical shoulder brace and arm sleeve absent of semiconductor fabric)
Shoulder SleeveDevice
One group will receive active therapy (active semiconductor embedded shoulder brace and arm sleeve)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | To assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo. Receives: Device: Placebo |
| Incrediwear Product | Active comparator | To assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo. Receives: Device: Shoulder Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Circumference Measure with a Measuring tape
To measure swelling in the upper arm, a soft tape measure to measure the circumference of the arm at multiple points at the writs, mid-forearm, axilla, and oblique. A 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is not optimal. Less than 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is optimal.
Measured: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
Secondary outcomes (2)
Visual Analogue Scale Measured by Scale
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.
Measured: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
Range of Motion Measured by a Goniometer
To measure the range of motion of the shoulder, the patient will:
Flexion: Move the arm forward and up until it's above the head. Extension: Move the arm backward. Abduction: Move the arm away from the body until it's above the head. Adduction: Move the arm toward the body. External rotation: With the elbow bent at a 90° angle, move the forearm away from the body.
Internal rotation: With the elbow bent at a 90° angle, move the forearm toward the body.
Shoulder flexion 0-180 degrees normal range Shoulder extension 0-60 degrees normal range Shoulder abduction 0-180 degrees normal range Shoulder adduction 180-0 degrees normal range Shoulder external rotation 0-90 degrees normal range Shoulder internal rotation 0-70 degrees normal range
...with lower number being poor and higher number being optimal
Measured: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start11 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Model description
- A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Bone and Joint
- Sponsor type
- University, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Responsible party
- Principal investigator, Christopher Flowers, MD, Texas Bone and Joint
- Investigators
- Christopher L. Flowers, Principal investigator, Texas Bone and Joint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669741
- Sponsor's protocol ID
- IRBNet 2246455-1
- Status last verified
- May 2025
- First submitted
- 30 Oct 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Pre-approval to share data and data results must be obtained by the corporation.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Semiconductor Embedded Therapeutic Garments From Incrediwear
- ClinicalTrials.gov ID
- NCT06669741
- Acronym / sponsor ID
- IRBNet 2246455-1
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Arthropathy of Left Shoulder (Disorder), Rotator Cuff Arthropathy of Right Shoulder (Disorder), Rotator Cuff Arthropathy of Bilateral Shoulders
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Texas Bone and JointUniversity, hospital or other
- Collaborators
- INCREDIWEAR HOLDINGS, INC.
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 1 Nov 2024 (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.
To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling.
Detailed description
Study Screening/pre-operative appointment
- The surgeon confirms the participant meets the inclusion criteria and is scheduled for surgery in the next few weeks.
- The surgeon will discuss the study and possible risks/benefits of being in the research.
- The study team will measure the participant wrist, arm, and shoulder circumference.
- The participant will rate their shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire; shoulder function with the American Shoulder and Elbow Surgeons Score (ASES) scale, and function limitations using the Western Ontario Rotator Cuff Index (WORC) questionnaire.
- The study team will measure the patient's shoulder's range of motion, stability, and strength.
- Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure.
- Day of Surgery
- A study packet will be given to the participant by the study staff. The packet will include a study number assignment, the products assigned, and the patient study journal. The participant, surgeon, and clinical staff will not know which group the participant is in.
- After surgery, the surgeon and PI, Dr. Flowers, will place the shoulder brace and arm sleeve according to the random assignment in the study packet. An abduction sling will then be placed on top of the shoulder brace and arm sleeve by Dr. Flowers.
- Participant will be instructed to wear the shoulder brace and arm sleeve for at least 20 hours per day, including overnight, for 12 weeks post-surgery.
- Participant will be instructed on the length of time to wear the shoulder abduction sling by the surgeon.
- The clinical staff will take arm circumference measurements post-surgery.
- Postoperative Recovery: Weeks 1-12
- Follow-up visits will be at 2 weeks, 6 weeks, and 12 weeks post-surgery. During follow-up visits:
- The clinical staff will take arm swelling measurements.
- Participant shoulder pain on a 1-10 Visual Analog Scale (VAS); shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons score (ASES), and Western Ontario Rotator Cuff Index (WORC) questionnaires.
- The clinical staff will measure shoulder's range of motion, stability, and strength.
- Radiographic assessments may be analyzed if already indicated for patient care and included in standard of care procedure.
- Daily reported measures include:
- Participant will record pain medication type and quantity taken in a medications log. Only medications related to the treatment of shoulder pain or function will be required to be reported.
- Participant will rate shoulder pain severity on a 1-10 VAS in a pain diary log.
- Participant will record how long they have worn the shoulder brace and arm sleeve in device usage log.
- At the 12th week follow-up visit all study products, including the shoulder brace, arm sleeve, medications log, pain diary log, and device usage log.
- Postoperative Recovery: 6 months and 1 year post surgery
- A follow-up phone call after 6 months and 1-year post-surgery will be administered.
- Participant will be asked to rate shoulder pain on a 1-10 Visual Analog Scale (VAS) and shoulder function with the Disabilities of the Arm, Shoulder, and Hand (DASH), American Shoulder and Elbow Surgeons score (ASES), and Western Ontario Rotator Cuff Index (WORC) questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: PlaceboTo assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo. |
| Incrediwear Product | Active comparator | Device: Shoulder SleeveTo assess the benefits of using the Incrediwear (Shoulder Sleeve) products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling. We will compare patients with Incrediwear products or placebo Incrediwear products throughout a 12-week period with follow-ups up to 1-year post-surgery. The study will be double blinded as to the active Incrediwear sleeve vs placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing arthroscopic rotator cuff repair
- Patients aged 18-75
- Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
- Patients who are willing and able to sign corresponding research subject consent form.
Key exclusion criteria (13 listed)
- Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
- Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
- Patient has had prior surgical treatment of a shoulder injury in the past 5 years
- Patient has chronic pain conditions unrelated to shoulder condition
- Patient has auto-immune or auto-inflammatory diseases
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 |
|---|---|---|
| PlaceboOne group will receive placebo therapy (identical shoulder brace and arm sleeve absent of semiconductor fabric) | Device | Placebo |
| Shoulder SleeveOne group will receive active therapy (active semiconductor embedded shoulder brace and arm sleeve) | Device | Incrediwear Product |
Primary outcome
Arm Circumference Measure with a Measuring tape
Time frame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
To measure swelling in the upper arm, a soft tape measure to measure the circumference of the arm at multiple points at the writs, mid-forearm, axilla, and oblique. A 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is not optimal. Less than 2cm difference between arms at each area of the wrist, mid-forearm, axilla, and oblique shoulder is optimal.
2 secondary outcomes
Visual Analogue Scale Measured by Scale
Time frame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
Range of Motion Measured by a Goniometer
Time frame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364
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 8 May 2025.
- Shoulder and Arm SleeveLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Pre-approval to share data and data results must be obtained by the corporation.
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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.
Christopher L. Flowers principal investigator
Texas Bone and Joint
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Sleeve in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Texas Bone and Joint 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 4 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 8 May 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm Circumference Measure with a Measuring tape (time frame: Preop appointment, Postop Day 42, Day 84, Day 168, Day 364). 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 8 May 2025.