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Completed

NCT Number: NCT03521856

Trial for Shoulder Pathology and Pain in Chronic SCI

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.

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Key information

Conditions

Shoulder Pain Arthralgia Central Nervous System Diseases Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

shoulder exercise

Behavioral

Exercises performed 3 times a week for 12 weeks

Education

Behavioral

Primary outcomes

  1. Change in shoulder pathology

    Time frame: Baseline to week 12

    Quantitative ultrasound measures of the supraspinatus tendon

Secondary outcomes

  1. Change in shoulder pain using the numerical rating scale

    Time frame: Baseline to week 12

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

  2. Change in shoulder pain using the numerical rating scale

    Time frame: Baseline to week 16

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

  3. Change in shoulder pain using the WUSPI

    Time frame: Baseline to week 12

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

  4. Change in shoulder pain using the WUSPI

    Time frame: Baseline to week 16

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

  5. Change in shoulder pathology

    Time frame: Baseline to week 16

    Quantitative ultrasound measures of the supraspinatus tendon

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • U.S. Department of Education

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 11, 2018
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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