Supraspinatus Tear
Conditions
Keywords
Ultrasonic tenotomy
Brief summary
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.
Interventions
PROCEDUREUltrasonic tenotomy
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain | Baseline, 2, 6, 12 and 24-weeks post-procedure | 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) |
| Change in shoulder active range of motion | Baseline, 2, 6, 12 and 24-weeks post-procedure | Measured using a goniometer reported in degrees |
| Change in shoulder strength | Baseline, 2, 6, 12 and 24-weeks post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Baseline, 2, 6, 12 and 24-weeks post-procedure | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Erickson, DO
Mayo Clinic
Outcome results
None listed