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Clinical Trials/NCT03521856
NCT03521856
Completed
Not Applicable

Trial for Shoulder Pathology and Pain in Chronic SCI

University of Miami1 site in 1 country35 target enrollmentMay 2, 2012
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ConditionsShoulder Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Pain
Sponsor
University of Miami
Enrollment
35
Locations
1
Primary Endpoint
Change in shoulder pathology
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.

Registry
clinicaltrials.gov
Start Date
May 2, 2012
End Date
August 31, 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Roy Felix

Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • •Candidates will be men or women, 18 years of age or older.
  • •Candidates must have an SCI and be at least 1 year post-diagnosis
  • •Candidates must use a wheelchair (manual or electric) for at least the majority of the time.
  • •Candidates must be able to transfer themselves without the help of others.
  • •The presence of at least moderate shoulder pain (rating of \>= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.

Exclusion Criteria

  • •Patients younger than 18 years of age.
  • •Patients who have a history of pre-injury rotator cuff tears or shoulder injury.
  • •Patients who do not use a wheelchair (manual or electric) at least 50% of the time.

Outcomes

Primary Outcomes

Change in shoulder pathology

Time Frame: Baseline to week 12

Quantitative ultrasound measures of the supraspinatus tendon

Secondary Outcomes

  • Change in shoulder pathology(Baseline to week 16)
  • Change in shoulder pain using the WUSPI(Baseline to week 16)
  • Change in shoulder pain using the numerical rating scale(Baseline to week 16)

Study Sites (1)

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