Arm Sleeves + PRP+ASC Injections for Tennis Elbow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: INCREDIWEAR HOLDINGS, INC.

Disqualifiers: Neurological conditions, Heart conditions, Auto-immune diseases, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to ease pain and improve elbow function for individuals with tennis elbow, a condition affecting the tendons around the elbow. The trial compares different treatments, including special arm sleeves with tiny semiconductor threads (Semiconductor Embedded Therapeutic Arm Sleeves) and injections with PRP+ASC, a mix of blood plasma and stem cells. Participants will be divided into groups to test the effectiveness of these treatments. Individuals diagnosed with tennis elbow who haven't had recent elbow surgery or injections might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could significantly enhance quality of life.

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 study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that arm sleeves with built-in technology improve blood flow, which can relieve pain and support the elbow. These sleeves consist of special materials that respond to body heat by emitting infrared waves, ensuring a safe and comfortable experience for users.

When combined with PRP (platelet-rich plasma) and ASC (adipose stem cell) injections, research indicates that PRP injections are safe and can reduce symptoms of elbow issues like tennis elbow. Few reports of negative side effects from these treatments suggest they are well-tolerated.

Overall, both the arm sleeves and the injections appear to be safe and promising options for managing elbow pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for tennis elbow, which often include physical therapy, anti-inflammatory medications, or corticosteroid injections, the investigational approach using semiconductor embedded therapeutic arm sleeves is unique. These sleeves are designed to enhance blood flow and tissue repair through the use of special semiconductor threads. Additionally, the combination of these sleeves with PRP (platelet-rich plasma) and ASC (adipose-derived stem cell) injections aims to further accelerate healing by leveraging the body's natural growth factors and regenerative cells. Researchers are excited about these treatments because they offer a non-invasive, innovative way to potentially speed up recovery and improve outcomes for patients with tennis elbow.

What evidence suggests that this trial's treatments could be effective for tennis elbow?

Studies have shown that arm sleeves made from special materials can help manage pain and improve elbow function in people with tennis elbow. This trial will evaluate different treatment arms, including semiconductor-embedded arm sleeves, known as Incrediwear, which may boost blood flow and reduce swelling. Another arm will test the combination of these sleeves with PRP (platelet-rich plasma) and ASC (fat stem cell) injections. Research suggests these injections could further aid healing by using the body's own cells to repair tissue damage. Participants who received PRP and ASC injections reported less pain and improved movement. Combining these treatments offers a promising option for those with tennis elbow. ^{1 4 6 7 8}

Who Is on the Research Team?

Dr. Matthew Bayes, MD, Medical

Principal Investigator

Bluetail Medical Group

Are You a Good Fit for This Trial?

This trial is for individuals with tennis elbow or tendonitis. Participants should have symptoms of ECRB tendinopathy and be willing to wear arm sleeves and receive injections in the affected area. Specific eligibility details are not provided, so general health requirements would apply.

Inclusion Criteria

Patients who are willing and able to sign corresponding research subject consent form

I can follow the study's schedule and rules.

My elbow condition was confirmed by an imaging test.

Exclusion Criteria

I have a complete tear in my ECRB tendon.

Patient has auto-immune or auto-inflammatory diseases

Patient has used tobacco within the last 90 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semiconductor embedded arm sleeves and PRP+ASC injections for ECRB tendinopathy

6 months

Regular visits at standardized intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semiconductor Embedded Therapeutic Arm Sleeves

Trial Overview The study compares three treatments: semiconductor embedded therapeutic arm sleeves, placebo (inactive) arm sleeves, and PRP+ASC injections for pain management and improved elbow function in patients with ECRB tendinopathy.

How Is the Trial Designed?

Group I: Incrediwear only Active Control 1 Intervention

One group will receive active therapy (semiconductor embedded arm sleeve) "Incrediwear only"

Group II: Incrediwear with PRP+ASC injections Active Control 2 Interventions

One group will receive active therapy with SOC (standard of care) PRP+ASC injections (active semiconductor embedded arm sleeves after they have received PRP+ ASC injections as part of their routine care) "Incrediwear with SOC PRP+ASC injections"

Group III: Sham Incrediwear Placebo Group 1 Intervention

One group will receive placebo therapy (arm sleeve absent of semiconductor thread) "Sham Incrediwear"

Group IV: Sham Incrediwear with PRP+ASC injections Placebo Group 2 Interventions

One group will receive placebo therapy with SOC (standard of care) PRP+ASC injections (arm sleeve absent of semiconductor fabric after they have received PRP+ASC injections as part of their routine care) "Sham Incrediwear with SOC PRP+ASC injections"

Who Is Running the Clinical Trial?

INCREDIWEAR HOLDINGS, INC.

Lead Sponsor

Trials

6

Recruited

630+

Published Research Related to This Trial

Autologous blood injections (ABIs) are more effective than corticosteroid injections for alleviating pain and disability in patients with tennis elbow, showing benefits in both the short and long term.

While platelet-rich plasma (PRP) injections also reduce pain, the improvement is not considered clinically meaningful compared to the effects of ABIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do autologous blood and PRP injections effectively treat tennis elbow? Widstrom, L., Slattengren, A.[2018]

In a study of 81 patients with tennis elbow, both platelet-rich plasma (PRP) and methylprednisolone injections resulted in similar reductions in pain and functional disability after 12 months, indicating comparable efficacy.

Patients in both treatment groups reported similar levels of satisfaction with their treatment, suggesting that either PRP or methylprednisolone can be effective options for managing tennis elbow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of Platelet-Rich Plasma versus local Methylprednisolone Injection in Lateral Epicondylitis. Shaikh, SA., Tahir, M., Ahmed, N.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06846593

The Comparison of Semiconductor Embedded Therapeutic ... This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT06846593/Prot_000.pdf

Research Protocol Incrediwear This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded ...

3. withpower.com withpower.com/trial/phase-ecrb-tendinopathy-10-2024-45c3a

Arm Sleeves + PRP+ASC Injections for Tennis Elbow This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded ...

4. malacards.org malacards.org/card/epicondylitis

Epicondylitis The Comparison and Combination of Semiconductor Embedded Therapeutic Arm Sleeves ... Effectiveness of extracorporeal shock wave therapy for tennis elbow (lateral ...

5. researchgate.net researchgate.net/publication/269177176_The_Efficacy_of_Low-Level_Laser_Therapy_for_Shoulder_Tendinopathy_A_Systematic_Review_and_Meta-Analysis_of_Randomized_Controlled_Trials_Low-Level_Laser_Therapy_for_Shoulder_Tendinopathy

The Efficacy of Low-Level Laser Therapy for Shoulder ... (2020) evaluated 60 patients with lateral epicondylitis (tennis elbow) and found that both HILT and lower-intensity laser treatments were ...

6. incrediwear.com incrediwear.com/products/incrediwear-elbow-sleeve?srsltid=AfmBOorXSqiC_QYvxe3bU9HDEPddgDEDJ6NNVBj37mhkPR27MsnYFaGF

Elbow Sleeve for Pain and Tendonitis Incrediwear's signature fabric blend is embedded with semiconductor elements to provide effortless comfort and exceptional durability · Increases blood flow ...

7. amazon.com amazon.com/Incrediwear-Incredibrace-Elbow-Sleeve-Brace/dp/B00AY1K2BW

Incrediwear Elbow Sleeve – Elbow Brace for ... MATERIAL: Incrediwear's proprietary fabric is embedded with body-heat-activated semiconductors, which emit infrared waves that are clinically proven to help ...

8. incrediwear.com incrediwear.com/products/incrediwear-arm-sleeve?srsltid=AfmBOoo__dUj6UUfDX2Vppn44RidlHFeBu7DgDQ6zemPULyTioQO4jNJ

Arm Sleeves for Pain Relief and Elbow Support Incrediwear's signature fabric blend is embedded with semiconductor elements to provide effortless comfort and exceptional durability · Increases blood flow ...