Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT03137394
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Model of Shoulder Pain Following Spinal Cord Injury
Sponsor:
Drexel University
Organization:
Study Overview
Official Title:
Development of a Biopsychosocial Prospective Surveillance Model of Shoulder Pain in Individuals With Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the progression of musculoskeletal (shoulder muscle flexibility, muscle strength, movement coordination, and rotator cuff health) and psychosocial (fear of movement, pain catastrophizing) impairments for the first year following SCI, starting with inpatient rehabilitation, at 6 months, and at 1 year following SCI.
We will use the information obtained from this study information to develop a biopsychosocial prospective surveillance model, a method for early detection, intervention, and moderation of shoulder pain. Specifically, we will identify sources of biopsychosocial shoulder pain to establish effective physical and cognitive-behavioral treatment to prevent loss of function and independence in individuals with SCI who depend on their arms for activities of daily living, transfers, and wheelchair propulsion.
We will use the information obtained from this study information to develop a biopsychosocial prospective surveillance model, a method for early detection, intervention, and moderation of shoulder pain. Specifically, we will identify sources of biopsychosocial shoulder pain to establish effective physical and cognitive-behavioral treatment to prevent loss of function and independence in individuals with SCI who depend on their arms for activities of daily living, transfers, and wheelchair propulsion.
Detailed Description:
Shoulder pain is a common secondary condition in people with spinal cord injury (SCI) that often results in loss of function and of independence and imposes limitations on self-care, work, and leisure activities, and leads to decreased quality of life. More than 40% of individuals with SCI report shoulder pain at the beginning of inpatient rehabilitation; this number increases to 50% at hospital discharge. The onset of shoulder pain within the first year after injury may lead to lifelong chronic shoulder pain. Although information is known about shoulder pain in patients with long-term SCI, little is known about the beginning of shoulder problems and how they progress early after the injury. In addition to physical problems, psychosocial factors are also associated with chronic pain.
This study will investigate the progression of musculoskeletal (shoulder muscle flexibility, muscle strength, movement coordination, and rotator cuff health) and psychosocial (fear of movement, pain catastrophizing) impairments for the first year following SCI, starting with inpatient rehabilitation, at 6 months, and at 1 year following SCI. Age- and gender-matched controls will be compared at baseline and at 1 year.
Instead of routinely screening patients to identify and treat related factors before shoulder pain and dysfunction become problems, the current practice is to start treatment after shoulder pain occurs. We will use the information obtained from this study information to develop a biopsychosocial prospective surveillance model, a method for early detection, intervention, and moderation of shoulder pain. Specifically, we will identify sources of biopsychosocial shoulder pain to establish effective physical and cognitive-behavioral treatment to prevent loss of function and independence in individuals with SCI who depend on their arms for activities of daily living, transfers, and wheelchair propulsion. Early identification of problem areas may provide a method to refer a patient for treatment or to change ongoing intervention. Development of a biopsychosocial prospective surveillance model will provide a proactive approach to reduce the debilitating consequences of activity limitations and participation restrictions in individuals with SCI, reducing the burden currently experienced by military service members, veterans, and their families and caregivers.
This study will investigate the progression of musculoskeletal (shoulder muscle flexibility, muscle strength, movement coordination, and rotator cuff health) and psychosocial (fear of movement, pain catastrophizing) impairments for the first year following SCI, starting with inpatient rehabilitation, at 6 months, and at 1 year following SCI. Age- and gender-matched controls will be compared at baseline and at 1 year.
Instead of routinely screening patients to identify and treat related factors before shoulder pain and dysfunction become problems, the current practice is to start treatment after shoulder pain occurs. We will use the information obtained from this study information to develop a biopsychosocial prospective surveillance model, a method for early detection, intervention, and moderation of shoulder pain. Specifically, we will identify sources of biopsychosocial shoulder pain to establish effective physical and cognitive-behavioral treatment to prevent loss of function and independence in individuals with SCI who depend on their arms for activities of daily living, transfers, and wheelchair propulsion. Early identification of problem areas may provide a method to refer a patient for treatment or to change ongoing intervention. Development of a biopsychosocial prospective surveillance model will provide a proactive approach to reduce the debilitating consequences of activity limitations and participation restrictions in individuals with SCI, reducing the burden currently experienced by military service members, veterans, and their families and caregivers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: