Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI

NCT02777281 | Completed

• 1 other identifier: 1405M50661
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two exercise programs in an interventional study for manual wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord injury will also be enrolled to compare exercise approaches.

Conditions

Shoulder Pain; Spinal Cord Injury

Keywords

Shoulder Pain; Wheelchair; Spinal Cord injury

Outcome Measures

Primary Outcomes (2)

• Muscle activity

  Muscle activity during exercises is measured as a change in EMG

  baseline

• Rotator cuff compression risk

  Motion and position data of the upper arm relative to the shoulder blade measured in degrees

  baseline

Study Arms (2)

Shoulder pain and SCI

OTHER

Manual wheelchair users with SCI

Behavioral: Shoulder pain and SCI

Shoulder pain and able bodies

OTHER

No SCI or wheelchair use but presence of shoulder pain

Behavioral: Shoulder pain and able bodies

Interventions

Shoulder pain and SCI BEHAVIORAL

Shoulder pain and SCI

Shoulder pain and SCI

Shoulder pain and able bodies BEHAVIORAL

Shoulder pain and able bodies

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Persons with paraplegia at least 1 year post SCI. Prior to this time patients are still adjusting to independent function with manual wheelchairs as their primary means of mobility. This criteria ensures the subjects have had sufficient exposure to the functional demands associated with their condition.
• Age 21 to 60 years old; below age 21, particularly in males, the humeral growth plate may not have fully closed. Including subjects above this age ensures skeletal maturity. After age 60, even in able-bodied individuals, substantial degenerative changes can begin to occur in the shoulder joint.
• Use of a manual wheelchair as the primary means of mobility (\> 50% time). This is the population with most risk of development of shoulder pain and associated secondary complications.
• A history of unilateral or bilateral shoulder pain that interferes with at least one functional task. Symptoms localized to the proximal anterior, lateral, or posterior glenohumeral (shoulder joint) region are required. Rotator cuff tendinopathy and "impingement" syndromes involve localized pain in this region. More diffuse symptoms are consistent with combined shoulder/neck syndromes or radiating pain from cervical spine pathology.

You may not qualify if:

• Inability to provide informed consent.
• Reproduction of shoulder pain, pain radiating down the upper extremity, numbness or tingling in the upper extremity, or other upper extremity symptoms during a cervical screening examination or thoracic outlet testing. This result would be indicative of primary cervical or thoracic outlet pathology.
• Shoulder pain of traumatic origin. Cumulative trauma disorders are of primary interest and most amenable to the proposed exercise interventions.
• History of shoulder surgery or dislocation.
• Recent history of fracture (within 1 year), hospitalization (within the past month), or cortisone injection to the shoulder (within 4 months). These conditions may interfere with safe or effective completion of the exercise intervention.
• A diagnosis or imaging findings of rheumatoid arthritis, end stage osteoarthritis, full thickness rotator cuff tear, adhesive capsulitis, or complex regional pain syndrome. These subjects may have joint disease progression that is severe, or not appropriately treated with a stretching and strengthening intervention.
• Diagnosed major depression, alcohol or substance abuse, or other serious medical conditions. These conditions may prevent subjects from regularly completing the exercise intervention
• All criteria apply to both groups excepting manual wheelchair use and SCI criteria not applicable to the able bodied subject group.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Paula M Ludewig, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 19, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

US (1)