Arm Sleeves + PRP+ASC Injections for Tennis Elbow

Recruiting in Palo Alto (17 mi)

Overseen ByDr. Matthew Bayes, MD, Medical

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: INCREDIWEAR HOLDINGS, INC.

No Placebo Group

Trial Summary

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.

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

I am between 18 and 65 years old.

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

I can follow the study's schedule and rules.

+1 more

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

+9 more

Participant Groups

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.

4Treatment groups

Active Control

Placebo Group

Group I: Incrediwear onlyActive Control1 Intervention

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

Group II: Incrediwear with PRP+ASC injectionsActive Control2 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 IncrediwearPlacebo Group1 Intervention

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

Group IV: Sham Incrediwear with PRP+ASC injectionsPlacebo Group2 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"