Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| INCREDIWEAR HOLDINGS, INC. | INDUSTRY |
Not provided
Not provided
Not provided
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.
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:
Daily reported measures include:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Device | One group will receive placebo therapy (identical shoulder brace and arm sleeve absent of semiconductor fabric) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preop appointment, Postop Day 42, Day 84, Day 168, Day 364 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher L. Flowers | Texas Bone and Joint | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical City Denton | Denton | Texas | 76210 | United States |
Not provided
| Label | URL |
|---|---|
| Shoulder and Arm Sleeve | View source |
Not provided
Pre-approval to share data and data results must be obtained by the corporation.
Not provided
Not provided
Not provided
Not provided
Not provided
A Randomized, Double-Blind, Placebo-Controlled Clinical Investigation
Not provided
Not provided
Not provided
| Shoulder Sleeve | Device | One group will receive active therapy (active semiconductor embedded shoulder brace and arm sleeve) |
|
| 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 | Preop appointment, Postop Day 42, Day 84, Day 168, Day 364 |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
Not provided
Not provided