Natural History of Shoulder Pathology in Manual Wheelchair Users

NCT02600910 | Active Not Recruiting

• 2 other identifiers: 22-012715-004974
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

Over 300,000 people in the United States have spinal cord injuries and many use manual wheelchairs for mobility. Most manual wheelchair users will develop shoulder injuries and pain that greatly affect quality of life and level of independence. Understanding when shoulder disease starts in manual wheelchair users and which daily activities contribute to the disease will provide necessary evidence for effective primary prevention methods to inhibit the development of further disability. Our central hypothesis is that the development of shoulder disease in manual wheelchair users will be strongly associated with the cumulative exposure to elevated shoulder postures combined with high upper body loading.

Conditions

Paraplegia; Spinal Cord Injuries; Shoulder Pain; Tendinopathy

Keywords

Manual Wheelchair; Shoulder injury; Shoulder function; rotator cuff; Tendinopathy; Spinal cord injury; Shoulder pain; Shoulder impingement

Outcome Measures

Primary Outcomes (1)

• Participant completion of MRI and Field measurements after 3 to 5 years follow-up.

  Investigators will use the standardized MRI Assessment of the shoulder guide to assess shoulder pathology and compare baseline shoulder condition on MRI to yearly follow-up. For the purposes of grading, pathology aside from rotator cuff tears will be assessed on an ordinal scale from 0-3 with 0 indicating no abnormality, 1 mild, 2 moderate, and 3 severe. Field measurements will be used to determine changes in upper extremity motion and loading from baseline across 3-5 years of follow-up.

  3-5 years

Secondary Outcomes (1)

• Development of the Conceptual Model of Preclinical Natural History of Shoulder Health Decline.

  3-5 years

Study Arms (2)

Manual Wheelchair User Cohort

Physical Exam. Screening exam performed by a licensed physical therapist to confirm inclusion/exclusion criteria. Assessment of Shoulder Function in Everyday Life. Shoulder motion \& hand loading data will be collected over a few days, twice per yr for 3-5 yrs in home \& community environment. Magnetic Resonance Imaging (MRI) of Shoulders. Imaging will use standard clinical protocol once per yr for 3-5 yrs. Shoulder Strength Testing. Once per yr for 3-5 yrs. Additional Variables. Updated demographic info will be collected yearly including but not limited to weight, chair type, health status, and job type.

Matched Able-bodied Cohort

Physical Exam. Screening exam performed by a licensed physical therapist to confirm inclusion/exclusion criteria. Assessment of Shoulder Function in Everyday Life. Shoulder motion \& hand loading data will be collected over a few days, twice per yr for 3-5 yrs in home \& community environment. Magnetic Resonance Imaging (MRI) of Shoulders. Imaging will use standard clinical protocol once per yr for 3-5 yrs. Shoulder Strength Testing. Once per yr for 3-5 yrs. Additional Variables. Updated demographic info will be collected yearly including but not limited to weight, health status, and job type.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 new manual wheelchair users with traumatic or non-traumatic spinal cord injuries (SCI) will be recruited \& consented during the first 2 years of this project. Subjects will be recruited at sites that treat \& rehabilitate people with acute SCI. SE MN \& neighboring states will be the 1st regions of recruitment. The inclusion and exclusion criteria were chosen to include a sample of the population of people with new SCIs who will use MWCs as their primary mode of mobility inside and outside the home. For 25 SCI participants, an age, sex, and activity level able-bodied matched participant will be recruited from the SE MN area.

You may qualify if:

• Group1 (Manual Wheelchair User Cohort):
• Participants with traumatic or non-traumatic spinal cord injury who have begun using a MWC within 12 months of enrollment
• years of age
• Use of a manual wheelchair as the primary mode of mobility
• Functional upper extremity range of motion
• Willingness to participate in study
• Ability to return to receive shoulder MRI 1-3 times/year , and once per year receive physical exam, and strength assessments.
• Group 2 (Matched Able-bodied Cohort):
• years of age
• Able to walk independently with no reliance on an orthotic, prosthetic, or gait aid
• Functional upper extremity range of motion
• Willingness to participate in study
• Ability to receive shoulder MRI 1-3 times/year, and once per year receive physical exam, and strength assessments.

You may not qualify if:

• Group1 (Manual Wheelchair User Cohort):
• Previous diagnosis of bilateral shoulder tendon tears prior to spinal cord injury or suspected tendon tears with physical exam
• Group 2 (Matched Able-bodied Cohort):
• Any documented musculoskeletal or neurological disorders that would be expected to impact shoulder health or change ability to walk independently
• Previous diagnosis of shoulder tears prior to enrollment or suspected tendon tears with physical exam

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Mayo Clinic: collaborator
• West Virginia University: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Paraplegia; Spinal Cord Injuries; Shoulder Pain; Tendinopathy; Shoulder Injuries; Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Melissa Morrow

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (2)