NCT03521856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4.3 years

First QC Date

April 29, 2018

Last Update Submit

September 12, 2022

Conditions

Shoulder Pain

Keywords

spinal cord injuriesSCI

Outcome Measures

Primary Outcomes (1)

  • Change in shoulder pathology

    Quantitative ultrasound measures of the supraspinatus tendon

    Baseline to week 12

Secondary Outcomes (5)

  • Change in shoulder pain using the numerical rating scale

    Baseline to week 12

  • Change in shoulder pain using the numerical rating scale

    Baseline to week 16

  • Change in shoulder pain using the WUSPI

    Baseline to week 12

  • Change in shoulder pain using the WUSPI

    Baseline to week 16

  • Change in shoulder pathology

    Baseline to week 16

Study Arms (2)

shoulder exercise intervention

EXPERIMENTAL

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.

Behavioral: shoulder exercise

education-only control

ACTIVE COMPARATOR

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

Behavioral: education

Interventions

shoulder exerciseBEHAVIORAL

Exercises performed 3 times a week for 12 weeks

shoulder exercise intervention
educationBEHAVIORAL
education-only control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

  • 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.

    PMID: 21292803BACKGROUND

  • 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.

    PMID: 31851011RESULT

MeSH Terms

Conditions

Shoulder PainSpinal Cord Injuries

Interventions

Educational Status

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Elizabeth R Felix, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 29, 2018

First Posted

May 11, 2018

Study Start

May 2, 2012

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)