Trial for Shoulder Pathology and Pain in Chronic SCI

Shoulder Pain Clinical Trial

Official title:

Trial for Shoulder Pathology and Pain in Chronic SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521856
• Other study ID #: 20111005
• Status: Completed
• Phase: N/A
• Start date: May 2, 2012
• Est. completion date: August 31, 2016

Study information

• Verified date: September 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Candidates will be men or women, 18 years of age or older.

2. Candidates must have an SCI and be at least 1 year post-diagnosis

3. Candidates must use a wheelchair (manual or electric) for at least the majority of the time.

4. Candidates must be able to transfer themselves without the help of others.

5. 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:

1. Patients younger than 18 years of age.

2. Patients who have a history of pre-injury rotator cuff tears or shoulder injury.

3. Patients who do not use a wheelchair (manual or electric) at least 50% of the time.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Behavioral:
• shoulder exercise
Exercises performed 3 times a week for 12 weeks
• education

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in shoulder pathology	Quantitative ultrasound measures of the supraspinatus tendon	Baseline to week 12
Secondary	Change in shoulder pain using the numerical rating scale	Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)	Baseline to week 12
Secondary	Change in shoulder pain using the numerical rating scale	Numerical rating scale for pain intensity (0 = no pain; 10 = most intense pain imaginable)	Baseline to week 16
Secondary	Change in shoulder pain using the WUSPI	Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)	Baseline to week 12
Secondary	Change in shoulder pain using the WUSPI	Wheelchair Users Shoulder Pain Index (WUSPI) (0 - 150)	Baseline to week 16
Secondary	Change in shoulder pathology	Quantitative ultrasound measures of the supraspinatus tendon	Baseline to week 16