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

INCREDIWEAR HOLDINGS, INC.

Status: Invitation-only

Conditions: ECRB Tendinopathy

Treatments: Other: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections; Device: Placebo Arm Sleeves; Device: Semiconductor Embedded Therapeutic Arm Sleeves

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846593

WCG IRB Protocol #20242832

2024-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with ECRB tendinopathy as determined by radiographic assessment or ultrasound imaging.
2. Patients age 18-65
3. Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
4. Patients who are willing and able to sign corresponding research subject consent form.

Exclusion criteria

1. Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
2. Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
3. Patient has had prior surgical treatment of the elbow in the last 5 years or injection treatment(s) in the last 2 years
4. Patient has complete tear of ECRB tendon or other surgical indication
5. Patient has chronic pain conditions unrelated to elbow condition
6. Patient has auto-immune or auto-inflammatory diseases
7. Patient has used tobacco within the last 90 days
8. Patient is not within the ages of 18-65
9. Patient has a history of metabolic disorders
10. Patient has an active infection (local or systemic)
11. Patient is unwilling or unable to sign the corresponding research subject consent form
12. Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Incrediwear only

Active Comparator group

Description:

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

Treatment:

Device: Semiconductor Embedded Therapeutic Arm Sleeves

Sham Incrediwear

Sham Comparator group

Description:

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

Treatment:

Device: Placebo Arm Sleeves

Incrediwear with PRP+ASC injections

Active Comparator group

Description:

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"

Treatment:

Device: Semiconductor Embedded Therapeutic Arm Sleeves

Other: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections

Sham Incrediwear with PRP+ASC injections

Sham Comparator group

Description:

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"

Treatment:

Device: Placebo Arm Sleeves

Other: Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) Injections