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

N/AEnrolling By InvitationNCT06846593

INCREDIWEAR HOLDINGS, INC.80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

ECRB Tendinopathy

Interventions

Semiconductor Embedded Therapeutic Arm SleevesDEVICE

labeled A or B, assigned based on blinded randomization table provided by the sponsor.

Placebo Arm SleevesDEVICE

labeled A or B, assigned based on blinded randomization table provided by the sponsor.

Platelet-Rich Plasma with Adipose Stem Cell (PRP+ASC) InjectionsOTHER

patients will choose or opt out of these standard of care injections.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bluetail Medical Group

Chesterfield, Missouri, United States

Outcomes

Primary Outcomes

Change in patient elbow function and pain as determined by the Patient-Rated Tennis Elbow Evaluation (PRTEE).

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

Time frame: 6 months

Secondary Outcomes

Change in pain as determined by the Visual Analog Scale (VAS).

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.

Time frame: 6 months

Change in patient elbow function as determined by the Disabilities of the Arm, Shoulder, and Hand (DASH).

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.

Time frame: 6 months

Change in grip strength as measured by a hand dynamometer

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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