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

80 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Arm Sleeves + PRP+ASC Injections for Tennis Elbow?

Research shows that PRP (platelet-rich plasma) injections can effectively reduce pain in tennis elbow patients, especially in younger individuals. This suggests that the PRP component of the treatment may help improve symptoms. ^{1 2 3 4 5}

How does the treatment of Arm Sleeves + PRP+ASC Injections for Tennis Elbow differ from other treatments?

This treatment is unique because it combines semiconductor embedded therapeutic arm sleeves with platelet-rich plasma (PRP) and adipose-derived stem cell (ASC) injections, potentially offering a novel approach by integrating physical support with biological therapies to enhance healing and reduce pain in tennis elbow. ^{1 2 4 6 7}

What is the purpose of this trial?

This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded fabric combined with PRP+ASC injections in the affected area.

Research Team

Dr. Matthew Bayes, MD, Medical

Principal Investigator

Bluetail Medical Group

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Do autologous blood and PRP injections effectively treat tennis elbow? [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A comparative study to evaluate the efficacy of platelet-rich plasma and triamcinolone to treat tennis elbow. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of the Clinical Results of Platelet-Rich Plasma, Steroid and Autologous Blood Injections in the Treatment of Chronic Lateral Epicondylitis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Functional Outcome of Platelet-Rich Plasma (PRP) Intra-lesional Injection for Tennis Elbow - A Prospective Cohort Study. [2022]

5. Pakistan pubmed.ncbi.nlm.nih.gov

Clinical efficacy of Platelet-Rich Plasma versus local Methylprednisolone Injection in Lateral Epicondylitis. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[Case-control study on local injection of autoallergic platelet rich plasma or whole blood for the treatment of tennis elbow]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Platelet-Rich Plasma (PRP) versus Autologous Whole Blood on Pain and Function Improvement in Tennis Elbow: A Randomized Clinical Trial. [2022]