Status:
WITHDRAWN
TrueRelief Efficacy for Supraspinatus Tendonitis
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
TrueRelief, LLC
Conditions:
Supraspinatus Tendinitis
Shoulder Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators hypothesize that TrueRelief will result in improved outcomes for patients with shoulder pain compared to those receiving the sham TrueRelief treatment. Also, it is likely that those ...
Detailed Description
Supraspinatus tendonitis (SST) is a common source of shoulder pain that primary care, sports medicine, and orthopedic surgeons regularly manage. TrueRelief's FDA-cleared device, called TrueRelief 1250...
Eligibility Criteria
Inclusion
- Those with shoulder pain of recent onset (\<3 months)
- Those with supraspinatus tendonitis only (see exclusion criteria below)
- Those whose physical examination meets either criteria below:
- Positive impingement tests
- At least two of:
- Jobe
- Modified Jobe
- Hawkins-Kennedy
- Neer
- Painful arc:
- Painful arc at 70-120 degrees abduction and/or
- Painful arc at 70-120 degrees flexion
- Pain with resisted abduction and/or external rotation
- Those between the ages of 18 and 65
- Those willing and able to sign consent
Exclusion
- Those who have had ipsilateral shoulder surgery involving the supraspinatus muscle
- Those who have experienced a fracture or avulsion fracture of any element of the shoulder or forequarter area (rib cage, clavicle, or humerus)
- Those with full-thickness rotator cuff tear
- Those with a long head of biceps rupture
- Those with shoulder pathology other than SST (ex: glenohumeral joint (GHJ) arthritis, adhesive capsulitis, labral tear). However, ACJ arthritis can be admitted since this is a very common comorbidity.
- Those with comorbidities that may confound the outcome, such as:
- Diabetes (either type I or type II)
- Auto-inflammatory diseases
- Auto-immune diseases
- Connective tissue disorders (Ehlers Danlos Syndrome)
- Those with demand type pacemakers
- Pregnancy
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05184985
Start Date
May 4 2022
End Date
June 1 2023
Last Update
July 3 2023
Active Locations (1)
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1
New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine
New York, New York, United States, 10065