Natural History of Shoulder Pathology in Manual Wheelchair Users

NCT ID: NCT02600910

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2026-08-31

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.

Detailed Description

Of the 1.7 million wheelchair users in the United States (US), 90 percent, or 1.5 million persons use manual wheelchairs (MWCs). People with traumatic and non-traumatic spinal cord injuries (SCI) make up approximately 20% of the MWC users, and 12,000 new traumatic SCIs occur every year. While MWCs are immediately available and enable independence, 63% of MWC users will have one or multiple rotator cuff tears after decades of MWC use as compared to 15% of age-matched able-bodied adults. A crucial gap in knowledge exists in understanding how the shoulder of MWC users functions from an almost permanent seated position as an agent for mobility, weight bearing, and hand grasping; and how this altered function translates to longitudinal shoulder health decline.

The objective of this application is to define the longitudinal components of the early phase (before chronic symptom onset) of shoulder health decline specific to new MWC users by characterizing the exposure to altered shoulder function and the associated MRI signs of early onset of shoulder pathology. The investigators propose to: (Aim 1) quantify shoulder joint motion and loading in the real world over 3 years in 50 new MWC users and a matched able-bodied cohort; (Aim 2) define early, preclinical changes on shoulder MRI specific to the MWC users, over 3 years, in comparison to the matched cohort; and (Aim 3) identify specific exposure measures as risk factors for early changes on MRI in the MWC users. Three central and novel aspects of this proposal will pave the way for targeting primary prevention: (1) characterizing the altered shoulder function in new MWC users in the real world with hardware and instrumentation suitable for multiple, day long collections, (2) defining the early, preclinical pattern of disease in users compared to a matched able-bodied cohort, and (3)investigating the combined effect of shoulder motion and loading and its relationship to the incidence of shoulder pathology.

Successful completion of this project will define how the shoulder responds to MWC use (Aim 1), identify the MWC-specific pattern of shoulder disease on MRI (Aim 2), and determine how altered shoulder function has contributed to shoulder health decline (Aim 3). This work provides the foundation for understanding the relative impact of shoulder elevation and loading in shoulder health decline. Additionally, this work provides the first building block in defining the complete natural history of shoulder disease in MWC users. The investigators expect the overall impact to be a powerful influence on environmental and assistive technology redesign, post-SCI rehabilitation practices, insurance reimbursement for shoulder health-preserving equipment, and understanding shoulder pathology in the general population.

Conditions

Paraplegia; Spinal Cord Injuries; Shoulder Pain; Tendinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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
• 18 - 70 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):

• 18-70 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Morrow

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Locations

Mayo Clinic

Rochester, Minnesota, United States

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

15-004974

Identifier Type: OTHER

Identifier Source: secondary_id

22-0127

Identifier Type: -

Identifier Source: org_study_id