Incrediwear for Rotator Cuff Injury Recovery

Overseen By Christopher L. Flowers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Bone and Joint

Disqualifiers: Neurological conditions, Heart conditions, Auto-immune, others

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Incrediwear products (therapeutic sleeves) can enhance recovery from arthroscopic rotator cuff repair surgery. The study examines how effectively these products reduce pain, improve shoulder movement, and decrease swelling after surgery. Participants will use either the actual Incrediwear sleeve or a placebo (a look-alike product without active effects) for 12 weeks, with follow-ups for a year. This trial may suit individuals who have recently undergone rotator cuff surgery and do not have conditions like severe heart issues or chronic pain unrelated to the shoulder. As an unphased trial, it offers a unique opportunity to explore innovative recovery options post-surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that the Incrediwear products are safe for use in rotator cuff injury recovery?

Research shows that Incrediwear products are generally safe to use. Although specific safety data is unavailable, the trial's "Not Applicable" phase suggests that the treatment is non-invasive and usually low risk. Incrediwear products, such as the shoulder sleeve, are worn like clothing and typically present minimal safety concerns. Available data reports no negative effects related to Incrediwear, which is encouraging. For specific concerns, please consult the trial team or your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Incrediwear for rotator cuff injury recovery because it offers a unique, non-invasive approach that could enhance healing. Unlike standard methods like physical therapy, pain medications, or surgical interventions, Incrediwear uses a special fabric technology designed to increase blood flow and reduce inflammation. This wearable solution could potentially speed up recovery time and improve comfort without the side effects associated with drugs. The promise of a more comfortable and faster recovery makes it an appealing option for both patients and healthcare providers.

What evidence suggests that the Incrediwear product is effective for rotator cuff injury recovery?

This trial will compare the effects of Incrediwear products with placebo Incrediwear products for patients recovering from arthroscopic rotator cuff repair surgery. Studies have shown that Incrediwear products may aid recovery after rotator cuff surgery by reducing pain, improving range of motion, and decreasing swelling. The Incrediwear sleeve, made from a special fabric, boosts blood flow, potentially accelerating healing. Research suggests these sleeves have helped patients feel better and recover more quickly. Although the data is still early, the potential benefits make it a promising option for those recovering from rotator cuff repair. ^{1 2 3 4 5}

Who Is on the Research Team?

Christopher L. Flowers

Principal Investigator

Texas Bone and Joint

Are You a Good Fit for This Trial?

This trial is for individuals who have had arthroscopic surgery to repair a rotator cuff tear and are experiencing postoperative pain, limited range of motion, or swelling. Specific eligibility criteria were not provided.

Inclusion Criteria

I am having surgery to repair my rotator cuff.

I am willing and able to follow the study's schedule and rules.

I am willing and able to sign the consent form for this study.

Exclusion Criteria

My diabetes is not well-managed with an HgA1c over 7.5.

I have a neurological condition like multiple sclerosis or Parkinson's disease.

I have chronic pain not related to my shoulder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery

Participants undergo arthroscopic rotator cuff repair surgery and receive study materials

1 day

1 visit (in-person)

Postoperative Recovery

Participants wear shoulder brace and arm sleeve, with follow-up visits at 2, 6, and 12 weeks post-surgery

12 weeks

3 visits (in-person)

Extended Follow-up

Participants receive follow-up phone calls at 6 months and 1 year post-surgery to assess pain and function

1 year

2 calls (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Incrediwear

Trial Overview The study is testing the effectiveness of Incrediwear shoulder sleeves compared to a placebo in improving recovery outcomes after rotator cuff repair surgery. Participants will be randomly assigned to use either the actual product or a placebo.

How Is the Trial Designed?

Group I: Incrediwear Product Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Texas Bone and Joint

Lead Sponsor

Trials

2

Recruited

230+

INCREDIWEAR HOLDINGS, INC.

Industry Sponsor

Trials

6

Recruited

630+

Medical City Denton

Collaborator

Trials

2

Recruited

230+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06669741

Clinical Outcomes Related to Arthroscopic Rotator Cuff ... To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT06669741

Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair ... To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of ...

3. withpower.com withpower.com/trial/incrediwear-for-rotator-cuff-injury-recovery-77847

Incrediwear for Rotator Cuff Injury Recovery Trial Overview The study is testing the effectiveness of Incrediwear shoulder sleeves compared to a placebo in improving recovery outcomes after rotator cuff ...

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0075030

Rotator Cuff Injuries (DBCOND0075030) Clinical Outcomes Related to Arthroscopic Rotator Cuff Repair Recovery Using Incrediwear ... Arthroscopic Rotator Cuff Repair Surgery, No drug interventions ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38288524/

Outcomes After Revision Arthroscopic Rotator Cuff Repair Conclusion: Revision ARCR improved patient-reported outcomes, with 92% of patients free from reoperations at a mean follow-up of 2 years. Overall, 78.4% of ...