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

May 20, 2026 updated by: INCREDIWEAR HOLDINGS, INC.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Bluetail Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Incrediwear only
One group will receive active therapy (semiconductor embedded arm sleeve) "Incrediwear only"
Device: Semiconductor Embedded Therapeutic Arm Sleeves
labeled A or B, assigned based on blinded randomization table provided by the sponsor.
Sham Comparator: Sham Incrediwear
One group will receive placebo therapy (arm sleeve absent of semiconductor thread) "Sham Incrediwear"
Device: Placebo Arm Sleeves
labeled A or B, assigned based on blinded randomization table provided by the sponsor.
Active Comparator: Incrediwear with PRP+ASC injections
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"
Device: Semiconductor Embedded Therapeutic 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.
Sham Comparator: Sham Incrediwear with PRP+ASC injections
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"
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient elbow function and pain as determined by the Patient-Rated Tennis Elbow Evaluation (PRTEE).
Time Frame: 6 months
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a self-administered questionnaire that assesses elbow pain and functional ability in patients with tennis elbow. The minimum number is zero meaning no pain and the maximum number is 10 meaning the worst imaginable pain. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain and minimal functional ability
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain as determined by the Visual Analog Scale (VAS).
Time Frame: 6 months
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The minimum number is zero meaning no pain and maximum number is 10 meaning the most pain the patient has every felt in their entire life. Lower scores are ideal while higher scores are indicative of the patient in a lot of pain.
6 months
Change in patient elbow function as determined by the Disabilities of the Arm, Shoulder, and Hand (DASH).
Time Frame: 6 months
The Disabilities of the Arm, Shoulder, and Hand (DASH) is a self-administered questionnaire that assesses the patient's functional ability and arm, shoulder, or hand pain. It is on a 5-point likert scale with 1= No difficulty, 2 = Mild difficulty, 3 = Moderate difficulty, 4 = Severe difficulty, and 5 = Unable. The score ranges from 0 to 100, with higher scores indicating greater disability.
6 months
Change in grip strength as measured by a hand dynamometer
Time Frame: 6 months
Patient's grip strength will be assessed with a hand dynamometer. The patient will squeeze the device with the patient's elbow at 90 degrees of flexion and wrist in 30 degrees of extension. A force output value in pounds (lbs) will be displayed and a higher number of force output indicates a stronger grip strength.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

INCREDIWEAR HOLDINGS, INC.

Investigators

  • Principal Investigator: Dr. Matthew Bayes, MD, Medical, Bluetail Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

September 16, 2025

Study Completion (Actual)

May 20, 2026

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCG IRB Protocol #20242832
  • 2024-06 (Other Identifier: Incrediwear)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be stored and used for the duration of time required to conduct analysis and publish all proposed peer-reviewed papers, according to study objectives. Data will be retained for 2 years after publication to allow for re-analysis that may be initiated in response to readers/reviewers. Subject records will be maintained at the PI's clinical site for a minimum of 7 years following latest study follow-up.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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