Development of a Model of Shoulder Pain Following Spinal Cord Injury
Development of a Biopsychosocial Prospective Surveillance Model of Shoulder Pain in Individuals With Spinal Cord Injury
1 other identifier
observational
69
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedMarch 31, 2022
March 1, 2022
3.3 years
April 28, 2017
March 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Musculoskeletal Pain Survey (MPS)-Change over time
Change in musculoskeletal pain will be assessed with the self-report Musculoskeletal Pain Survey.\[20\] This questionnaire asks the person to rate the presence, seriousness, and frequency of pain in the joints or muscles of the upper extremities. A composite pain score is calculated for bilateral upper extremities, ranging from 0 to 90. The shoulder pain score will also be analyzed separately (score 0 to 30). This scale has been used to identify musculoskeletal pain in individuals with SCI.\[20-22\]
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Pectoralis Minor Muscle Length Change over time
Manual palpation will identify the fourth rib and the coracoid process.\[47\] Pectoralis minor length will be measured as the distance between the fourth rib and coracoid process under two testing conditions: resting posture and passive lengthening.\[48\] Pectoralis minor muscle length will be measured as the distance between the two landmarks (cm) with the Palpation Meter (PALM, St. Paul, MN).\[47\] We have established excellent measurement properties for our procedure of measuring pectoralis minor muscle length under resting and passive lengthening conditions (ICC2,2=0.86-0.94, MDC95 =1.77cm).\[49\]
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Shoulder Girdle Tissue Integrity Change over time
Musculoskeletal ultrasound with a multifrequency, broadband, 50-mm linear array transducer will be used to obtain images of the subscapularis supraspinatus infraspinatus and biceps tendons, acromiohumeral distance, and supraspinatus muscle fatty infiltrate.5\[0\] Accuracy of musculoskeletal ultrasound for detection of rotator cuff tears is reported to be 88.9% (95% confidence interval =74.1 to 96.21).\[51\] Dr. Trojian has extensive training in the use of diagnostic ultrasound of the shoulder complex and will perform the ultrasound examinations. One assessor, masked to participant group and age, will provide the clinical interpretation of the finding and identify changes over time.
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Tampa Scale of Kinesiophobia Scale (TSK-11)-Change over time
The TSK-11 is used to assess fear of movement (kinesiophobia).41,42 The validated 11-item version (TSK-11)\[52\] gives a score range of 11 to 44, with higher scores indicating higher fear of movement and reinjury. The TSK -11 comprises opinion-based items that evaluate the participants' general status on a scale of 1 to 4 (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree). TSK-11 offers excellent reliability (ICC=0.81, SEM=2.54).5\[2\]
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Fear of Pain Questionnaire (FPQ)-Change over time
The FPQ43 is a 30-item measure of fear of painful stimuli. The FPQ includes three subscale scores for minor pain, severe pain, and medical pain. For each painful situation described on the FPQ, participants rate how "fearful" they are on a scale from 1 (not at all) to 5 (extreme). Previous research reported adequate internal consistency (α range, 0.86-0.87) on the FPQ scales.\[53\]
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Pain Catastrophizing Scale (PCS)-Change over time
The PCS consists of 13 items rated on a 5-point scale (0=not all to 4=all the time).\[27\] Participants are instructed to rate the degree to which specified thoughts and feelings occur when experiencing pain. Three dimensions of pain catastrophizing are assessed: rumination, magnification, and helplessness. Only the total score was used in the current study. The PCS is validated for clinical and nonclinical populations.\[27,36,53,54\]
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Subjective Quality of Life Questionnaire (SQoL)-Change over time
This questionnaire is a global measure of subjective perception of QoL.\[55\] The scale is a Likert-type scale measuring satisfaction with life as a whole: Participants are asked to take everything in their life into account and rate it on an ordinal scale from 1 (life is very distressing; it's hard to imagine how it could get much worse) to 7 (life is great; it's hard to imagine how it could get much better).\[56\] Test-retest reliability is high (91% agreement),\[55\] and this questionnaire is validated with the SCI population.\[55,57,58\] Dr. Mulroy holds expertise and experience in using psychosocial measures in individuals with SCI and will oversee the analysis and interpretation of these primary and secondary measures.
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Secondary Outcomes (2)
Muscle Strength-Change over time
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Chronic Pain Coping Inventory-42 (CPCI-42)-Change over time
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Other Outcomes (1)
Upper Extremity Kinematic/ Intersegmental Coordination-Change over time
SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Study Arms (2)
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;
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Drexel Universitylead
- University of Maryland, Baltimorecollaborator
Study Sites (2)
University of Maryland Rehabilitation and Orthopedic Institute
Gwynn Oak, Maryland, 21207, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
Related Publications (3)
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.
PMID: 34282128BACKGROUNDFinley 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.
PMID: 32753624BACKGROUNDFinley 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.
PMID: 32796138BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret A Finley, PT,PhD
Drexel University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 2, 2017
Study Start
October 1, 2017
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
Results will be presented at annual meetings, as described below as well as anticipated numerous manuscripts, regardless of the results. The outcomes will be of interest to the public, researchers, policy makes, and funding sources. Final Research Data (de-identified and unidentifiable) defined as recorded factual material commonly accepted in the scientific community as necessary to document and support research findings will be available upon request of such agencies as the DOD, the Food and Drug Administration (FDA), Medicare/Medicaid, or others who hold interest or cause to review the raw data. No protected health information (PHI) will be collected for this study.