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Trial for Shoulder Pathology and Pain in Chronic SCI

Primary Purpose

Shoulder Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

shoulder exercise

education

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring spinal cord injuries, SCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

shoulder exercise intervention

education-only control

Arm Description

A home exercise intervention for strengthening and stretching the shoulders - Strengthening and Optimal Movement for Painful Shoulders (STOMPS) - performed 3 times per week for 12 weeks.

Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain

Outcomes

Primary Outcome Measures

Change in shoulder pathology

Quantitative ultrasound measures of the supraspinatus tendon

Secondary Outcome Measures

Change in shoulder pain using the numerical rating scale

Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)

Change in shoulder pain using the numerical rating scale

Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)

Change in shoulder pain using the WUSPI

Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)

Change in shoulder pain using the WUSPI

Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)

Change in shoulder pathology

Quantitative ultrasound measures of the supraspinatus tendon

Full Information

NCT ID

NCT03521856

First Posted

April 29, 2018

Last Updated

September 12, 2022

Sponsor

University of Miami

Collaborators

U.S. Department of Education

1. Study Identification

Unique Protocol Identification Number

NCT03521856

Brief Title

Trial for Shoulder Pathology and Pain in Chronic SCI

Official Title

Trial for Shoulder Pathology and Pain in Chronic SCI

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

May 2, 2012 (Actual)

Primary Completion Date

August 31, 2016 (Actual)

Study Completion Date

August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

U.S. Department of Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

spinal cord injuries, SCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

shoulder exercise intervention

Arm Type

Experimental

Arm Description

A home exercise intervention for strengthening and stretching the shoulders - Strengthening and Optimal Movement for Painful Shoulders (STOMPS) - performed 3 times per week for 12 weeks.

Arm Title

education-only control

Arm Type

Active Comparator

Arm Description

Subjects watched a 1 hour educational video on shoulder anatomy, mechanisms of shoulder injury and pain, and hints for managing shoulder pain

Intervention Type

Behavioral

Intervention Name(s)

shoulder exercise

Intervention Description

Exercises performed 3 times a week for 12 weeks

Intervention Type

Behavioral

Intervention Name(s)

education

Primary Outcome Measure Information:

Title

Change in shoulder pathology

Description

Quantitative ultrasound measures of the supraspinatus tendon

Time Frame

Baseline to week 12

Secondary Outcome Measure Information:

Title

Change in shoulder pain using the numerical rating scale

Description

Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)

Time Frame

Baseline to week 12

Title

Change in shoulder pain using the numerical rating scale

Description

Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)

Time Frame

Baseline to week 16

Title

Change in shoulder pain using the WUSPI

Description

Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)

Time Frame

Baseline to week 12

Title

Change in shoulder pain using the WUSPI

Description

Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)

Time Frame

Baseline to week 16

Title

Change in shoulder pathology

Description

Quantitative ultrasound measures of the supraspinatus tendon

Time Frame

Baseline to week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth R Felix, PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21292803

Citation

Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.

Results Reference

background

PubMed Identifier

31851011

Citation

Cardenas DD, Felix ER, Cowan R, Orell MF, Irwin R. Effects of Home Exercises on Shoulder Pain and Pathology in Chronic Spinal Cord Injury: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2020 Jun;99(6):504-513. doi: 10.1097/PHM.0000000000001362.

Results Reference

result

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Trial for Shoulder Pathology and Pain in Chronic SCI

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