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Behavioural Intervention
TrueRelief device for Rotator Cuff Tendinitis
N/A
Waitlist Available
Led By Vandana Sood, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Summary
This trial is testing if a new device, TrueRelief, can help improve shoulder pain for patients. The investigators think that patients with fewer medical problems will see the most improvement.
Eligible Conditions
- Rotator Cuff Tendinitis
- Shoulder Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain measurements in patients with Supraspinatus Tendonitis (SST).
Secondary study objectives
Change in perceived shoulder function as measured by QuickDASH Questionnaire in patients with Supraspinatus Tendonitis (SST).
Change in perceived shoulder function as measured by a Shoulder Rating Questionnaire in patients with Supraspinatus Tendonitis (SST).
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Patients receive an experimental procedure using a TrueRelief device.
Group II: PlaceboPlacebo Group1 Intervention
Patients receive a placebo procedure using a sham TrueRelief device that looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TrueRelief device
2022
N/A
~140
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,081 Previous Clinical Trials
1,138,039 Total Patients Enrolled
TrueRelief, LLCUNKNOWN
1 Previous Clinical Trials
134 Total Patients Enrolled
Vandana Sood, MDPrincipal InvestigatorWeill Medical College of Cornell University
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