By InvitationNot Applicable

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

United States80 participantsStarted 2024-11-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT06846593

SponsorINCREDIWEAR HOLDINGS, INC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-16

View on ClinicalTrials.gov More ECRB Tendinopathy trials