Novel Treatment for Rotator Cuff Tears

Mayo Clinic15 enrolled

Overview

The focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (\<50%) of the supraspinatus tendon of the rotator cuff.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Supraspinatus Tear

Interventions

Ultrasonic tenotomyPROCEDURE

Ultrasonic procedure as part of standard of care, as clinically indicated, to stimulate healing of the partial tear. The procedure uses ultrasound guidance that allows a needlelike device to gradually break up and remove tendinopathic tendon tissue.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Evidence of partial tear (\< 50%) of the supraspinatus tendon on MRI. Exclusion Criteria: * A tear of the supraspinatus tendon greater \> 50% and any areas of full thickness tearing, concomitant tears \> 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum. * Evidence of systemic illness/infection requiring oral or IV antibiotics during the recruitment period. * Evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder. * Previous corticosteroid injection within three months. * Those individuals less than 25 and greater than 75 years of age will be excluded.

Locations (1)

Mayo Clinic Health System - Onalaska

Onalaska, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Change in pain

Measured using a visual analog scale (VAS), used to measure subjective pain, rated from 0 (no pain) to 100 (most severe pain) at rest and during activity (previously painful activities)

Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

Change in shoulder active range of motion

Measured using a goniometer reported in degrees

Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

Change in shoulder strength

Assessed using a hand-held dynamometer (HHD) placed distally on the forearm, just proximal to the wrist joint along the distal radius and ulna with instruction to push into the HHD with maximum force production for approximately 5 seconds.

Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

Secondary Outcomes

Change in quality of life

Measured using the SF-36 Quality of Life questionnaire which is a 36-item self-reported health survey that measures health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.

Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

Data from ClinicalTrials.gov

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