NCT06846593

The Comparison of Semiconductor Embedded Therapeutic Arm Sleeves for the Treatment of ECRB Tendinopathy

The Comparison and Combination of Semiconductor Embedded Therapeutic Arm Sleeves and Platelet-Rich Plasma With Adipose Stem Cell (PRP+ASC) Injections for the Treatment of ECRB Tendinopathy (Lateral Epicondylitis): A Randomized, Double-Blinded, Placebo-Controlled Prospective Clinical Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: INCREDIWEAR HOLDINGS, INC. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Extensor Carpi Radialis Brevis (ECRB) tendinopathy, also known as lateral epicondylitis or tennis elbow, is the most prevalent elbow soft tissue injury and affects 1-3% of the population. Repetitive overloading of the tendon and ligaments in the elbow lead to microtraumas, causing abnormal angiofibroblastic remodeling and increased pain. Microtearing occurs most commonly at the origin of the extensor carpi radialis brevis (ECRB) tendon. The main symptoms include a loss of grip strength, a burning sensation near the ECRB origin site, and pain during daily activities such as grasping objects or shaking hands. Both conditions present a significant injury and treatment burden on the population and effective treatment and pain management approaches with minimal side effects are needed. Novel nonsurgical treatment approaches for ECRB tendinopathy include platelet-rich plasma (PRP) injections and stem cell therapy. Ultrasound-guided PRP and adipose-derived stem cells (ASCs) injections have shown to be an effective treatment option for patients with chronic ECRB tendinopathy. The proposed study seeks to assess the effect of non-compressive semiconductor embedded arm sleeves in combination with PRP + ASC injections, throughout a 6-month rehabilitation course for patients with ECRB tendinopathy. Outcome measures will be collected at standardized intervals to evaluate and compare treatment groups.

Conditions

• ECRB Tendinopathy

Interventions

Type	Name	Description
DEVICE	Semiconductor Embedded Therapeutic Arm Sleeves	labeled A or B, assigned based on blinded randomization table provided by the sponsor.
DEVICE	Placebo Arm Sleeves	labeled A or B, assigned based on blinded randomization table provided by the sponsor.
OTHER	Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections	patients will choose or opt out of these standard of care injections.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-09-16
• Completion: 2025-11-01
• First posted: 2025-02-26
• Last updated: 2025-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study