Clinical trial NCT03137394: Development of a Model of Shoulder Pain Following Spinal Cord Injury
Official title: Development of a Biopsychosocial Prospective Surveillance Model of Shoulder Pain in Individuals With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
shoulder pain
psychosocial
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
First posted: 2017-05-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 68 individuals across both sites will be enrolled \[34 at each the Drexel site and the University of Maryland Rehabilitation \& Orthopaedic Institute (UM Rehab)\].

Participants with SCI will be recruited through the Magee Rehabilitation Hospital network (see letter of support). Individuals without SCI will be recruited from the local community. A member of the research team will serve will identify, screen, and obtain consent from interested, eligible individuals in the group with acute SCI. Individuals for the control group will be recruited with flyers and through personal contact with Magee Rehabilitation Hospital, UMRehab, and the community at large.

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.

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.

Primary outcomes:
measure: Musculoskeletal Pain Survey (MPS)-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
measure: Pectoralis Minor Muscle Length Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
measure: Shoulder Girdle Tissue Integrity Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
measure: Tampa Scale of Kinesiophobia Scale (TSK-11)-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
measure: Fear of Pain Questionnaire (FPQ)-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
measure: Pain Catastrophizing Scale (PCS)-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
measure: Subjective Quality of Life Questionnaire (SQoL)-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Secondary outcomes:
measure: Muscle Strength-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
measure: Chronic Pain Coping Inventory-42 (CPCI-42)-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Other outcomes:
measure: Upper Extremity Kinematic/ Intersegmental Coordination-Change over time
timeFrame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Locations:
city: Gwynn Oak
country: United States
facility: University of Maryland Rehabilitation and Orthopedic Institute
state: Maryland
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Margaret A Finley, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.