TrueRelief Efficacy for Supraspinatus Tendonitis (NCT05184985) | Clinical Trial Compass
WithdrawnNot Applicable
TrueRelief Efficacy for Supraspinatus Tendonitis
Stopped: The study was closed due to recruitment challenges. The study design involved frequent visits 3 times a week for 3 consecutive weeks which many prospective participants were not able to commit to.
United States0Started 2022-05-04
Plain-language 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 with fewer medical comorbidities will experience the greatest improvement.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain measurements in patients with Supraspinatus Tendonitis (SST).
Timeframe: Beginning of study (Visit 1 - Week 1), Midpoint of Study (Visit 5 - Week 2), End of study (Visit 9 - Week 3), 1-month post-treatment follow-up call (Week 7-9)
Trial details
NCT IDNCT05184985
SponsorWeill Medical College of Cornell University