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

NCT06846593 | Enrolling By Invitation FDA Device

• 2 other identifiers: WCG IRB Protocol #202428322024-06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ECRB Tendinopathy

Keywords

ECRB; lateral epicondylitis; tendinopathy; tennis elbow; extensor carpi radialis brevis; platelet-rich plasma; PRP; stem cell therapy; arm sleeves

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (3)

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

  6 months

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

  6 months

• Change in grip strength as measured by a hand dynamometer

  6 months

Study Arms (4)

Incrediwear only

ACTIVE COMPARATOR

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

Device: Semiconductor Embedded Therapeutic Arm Sleeves

Sham Incrediwear

SHAM COMPARATOR

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

Device: Placebo Arm Sleeves

Incrediwear with PRP+ASC injections

ACTIVE COMPARATOR

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

Sham Incrediwear with PRP+ASC injections

SHAM COMPARATOR

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

Interventions

Semiconductor Embedded Therapeutic Arm Sleeves DEVICE

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

Incrediwear only; Incrediwear with PRP+ASC injections

Placebo Arm Sleeves DEVICE

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

Sham Incrediwear; Sham Incrediwear with PRP+ASC injections

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

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

Incrediwear with PRP+ASC injections; Sham Incrediwear with PRP+ASC injections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
• Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
• Patient has had prior surgical treatment of the elbow in the last 5 years or injection treatment(s) in the last 2 years
• Patient has complete tear of ECRB tendon or other surgical indication
• Patient has chronic pain conditions unrelated to elbow condition
• Patient has auto-immune or auto-inflammatory diseases
• Patient has used tobacco within the last 90 days
• Patient is not within the ages of 18-65
• Patient has a history of metabolic disorders
• Patient has an active infection (local or systemic)
• Patient is unwilling or unable to sign the corresponding research subject consent form
• 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.

Sponsors & Collaborators

• INCREDIWEAR HOLDINGS, INC.: lead

Study Sites (1)

Bluetail Medical Group

Chesterfield, Missouri, 63005, United States

Location

Related Publications (19)

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Related Links

• Empowering Recovery: Surface Electromyography Shows how Incrediwear Helps Professional Athletes Recover

MeSH Terms

Conditions

Tennis Elbow; Tendinopathy

Interventions

Injections

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dr. Matthew Bayes, MD, Medical

  Bluetail Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will determine whether they would like to receive Standard of Care (SOC) PRP+ASC injections. Then, the subjects will be randomly assigned to the study group in which they will receive a real or sham semiconductor embedded sleeve. The subjects will be instructed to wear the sleeve for a minimum of 12 hours per day, including overnight, for the entire duration of the study.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: February 26, 2025
• Study Start: November 1, 2024
• Primary Completion: September 16, 2025
• Study Completion: November 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)