Supraspinatus TearNCT05590494
Novel Treatment for Rotator Cuff Tears
A study testing Ultrasonic tenotomy in people with Supraspinatus Tear, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Supraspinatus Tear
- What is being tested?
- Ultrasonic tenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of partial tear (< 50%) of the supraspinatus tendon on MRI.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Health System - Onalaska
Onalaska, Wisconsin, 54650
Jacob Erickson, DO, 608-392-9876, erickson.jacob@mayo.edu
About this study
Official title: Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study
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.
- Conditions
- Supraspinatus Tear
- Being tested
- Ultrasonic tenotomy
- Keywords
- Ultrasonic tenotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic tenotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Repair a partially torn rotator cuff | Other | Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated Receives: Procedure: Ultrasonic tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 2, 6, 12 and 24-weeks post-procedure
Change in shoulder active range of motion
Measured using a goniometer reported in degrees
Measured: 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.
Measured: Baseline, 2, 6, 12 and 24-weeks post-procedure
Secondary outcomes (1)
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.
Measured: Baseline, 2, 6, 12 and 24-weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start7 Nov 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TearStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob L. Erickson, Mayo Clinic
- Investigators
- Jacob Erickson, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590494
- Sponsor's protocol ID
- 21-011522
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05590494
- Acronym / sponsor ID
- 21-011522
- Conditions
- Supraspinatus Tear
- Keywords
- Ultrasonic tenotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repair a partially torn rotator cuff | Other | Procedure: Ultrasonic tenotomySubjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Evidence of partial tear (< 50%) of the supraspinatus tendon on MRI.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic tenotomyUltrasonic 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. | Procedure or surgery | Repair a partially torn rotator cuff |
Primary outcome
Change in pain
Time frame: 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
Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure
Measured using a goniometer reported in degrees
Change in shoulder strength
Time frame: 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.
1 secondary outcome
Change in quality of life
Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Supraspinatus Tear
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Erickson, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic tenotomy in people with Supraspinatus Tear, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain (time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.