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

Primary Purpose

Shoulder Pain, Spinal Cord Injury

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoulder pain and SCI
Shoulder pain and able bodies
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Pain focused on measuring Shoulder Pain, Wheelchair, Spinal Cord injury

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Exclusion Criteria:

  1. Inability to provide informed consent.
  2. 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.
  3. Shoulder pain of traumatic origin. Cumulative trauma disorders are of primary interest and most amenable to the proposed exercise interventions.
  4. History of shoulder surgery or dislocation.
  5. 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.
  6. 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.
  7. 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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Shoulder pain and SCI

Shoulder pain and able bodies

Arm Description

Manual wheelchair users with SCI

No SCI or wheelchair use but presence of shoulder pain

Outcomes

Primary Outcome Measures

Muscle activity
Muscle activity during exercises is measured as a change in EMG
Rotator cuff compression risk
Motion and position data of the upper arm relative to the shoulder blade measured in degrees

Secondary Outcome Measures

Full Information

First Posted
May 14, 2014
Last Updated
February 20, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02777281
Brief Title
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
Official Title
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators hypothesis is that the biomechanically based exercise program will demonstrate greater muscle activation of targeted muscles, and reduced compression risk to the rotator cuff tendons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Spinal Cord Injury
Keywords
Shoulder Pain, Wheelchair, Spinal Cord injury

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shoulder pain and SCI
Arm Type
Other
Arm Description
Manual wheelchair users with SCI
Arm Title
Shoulder pain and able bodies
Arm Type
Other
Arm Description
No SCI or wheelchair use but presence of shoulder pain
Intervention Type
Behavioral
Intervention Name(s)
Shoulder pain and SCI
Intervention Description
Shoulder pain and SCI
Intervention Type
Behavioral
Intervention Name(s)
Shoulder pain and able bodies
Primary Outcome Measure Information:
Title
Muscle activity
Description
Muscle activity during exercises is measured as a change in EMG
Time Frame
baseline
Title
Rotator cuff compression risk
Description
Motion and position data of the upper arm relative to the shoulder blade measured in degrees
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula M Ludewig, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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