Development of a Model of Shoulder Pain Following Spinal Cord Injury

NCT ID: NCT03137394

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-01-31

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.

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.

Conditions

Spinal Cord Injury

Study Design

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

Study Groups

Spinal Cord Injury

Participants with SCI in the acute, in-patient rehabilitation phase.Data for each participant in the SCI group will be collected at baseline, 6 months, and 1 year post injury;

Observation

Intervention Type: OTHER

Data for each participant in the SCI group will be collected at baseline, 6 months, and 1 year post injury; control group data will be collected at baseline and at the 1-year follow-up.

Able-bodied control

Age- and gender-matched able-bodied individuals (matched to SCI group). Control group data will be collected at baseline and at the 1-year follow-up.

Observation

Intervention Type: OTHER

Data for each participant in the SCI group will be collected at baseline, 6 months, and 1 year post injury; control group data will be collected at baseline and at the 1-year follow-up.

Interventions

Observation

Data for each participant in the SCI group will be collected at baseline, 6 months, and 1 year post injury; control group data will be collected at baseline and at the 1-year follow-up.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals will be eligible for participation if they are >18 years of age and included in the SCI group if they demonstrate a complete or incomplete SCI of American Spinal Injury Association grade A, B, C or D45; attend inpatient rehabilitation following SCI; use a manual wheelchair for at least 50% mobility; and are medically stable.
• The control group will able-bodied (non-SCI) and be age and sex matched to the SCI group

Exclusion Criteria

• Individuals will be excluded from participating in either group if they present with upper extremity radicular symptoms; preexisting neurological conditions; and complications from other health conditions that could influence upper extremity function.
• Control group: Individuals will be excluded from participating in any group if they present with preexisting neurological conditions; and complications from other health conditions that could influence upper extremity function.

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

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Margaret A. Finley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret A Finley, PT,PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

University of Maryland Rehabilitation and Orthopedic Institute

Gwynn Oak, Maryland, United States

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

References

Finley M, Euiler E, Baehr L, Gracely E, Brownsberger M, Schmidt-Read M, Frye SK, Kallins M, Summers A, York H, Geigle PR. Relationship of psychosocial factors and musculoskeletal pain among individuals with newly acquired spinal cord injury. Spinal Cord Ser Cases. 2021 Jul 19;7(1):61. doi: 10.1038/s41394-021-00415-4.

Reference Type: BACKGROUND

PMID: 34282128 (View on PubMed)

Finley M, Euiler E, Trojian T, Gracely E, Schmidt-Read M, Frye SK, Kallins M, Summers A, York H, Geigle PR. Shoulder impairment and pain of individuals with newly acquired spinal cord injury compared to uninjured peers. Spinal Cord Ser Cases. 2020 Aug 4;6(1):68. doi: 10.1038/s41394-020-0318-1.

Reference Type: BACKGROUND

PMID: 32753624 (View on PubMed)

Finley MA, Euiler E, Hiremath SV, Sarver J. Movement Coordination During Humeral Elevation in Individuals With Newly Acquired Spinal Cord Injury. J Appl Biomech. 2020 Aug 14;36(5):345-350. doi: 10.1123/jab.2019-0387. Print 2020 Oct 1.

Reference Type: BACKGROUND

PMID: 32796138 (View on PubMed)

Other Identifiers

SC160041

Identifier Type: -

Identifier Source: org_study_id