Spinal Cord InjuryNCT03137394
Development of a Model of Shoulder Pain Following Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Drexel University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Observation
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2017to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Rehabilitation and Orthopedic Institute
Gwynn Oak, Maryland, 21207
Drexel University
Philadelphia, Pennsylvania, 19102
About this study
Official title: Development of a Biopsychosocial Prospective Surveillance Model of Shoulder Pain in Individuals With Spinal Cord Injury
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.
Read the 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
- Being tested
- Observation
- Keywords
- spinal cord injury, shoulder pain, psychosocial
- Medical subject headings
- Spinal Cord Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Other: Observation | |
| 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. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: 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.
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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.
Measured: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Secondary outcomes (2)
Muscle Strength-Change over time
We will collect measures of shoulder girdle muscle abduction, adduction, internal rotation, and external rotation strength. Standard manual muscle testing positions of Kendall et al.[59] will be used when possible; a modification of the position will be used in an effort to perform all tests with participants seated in their wheelchairs. A handheld dynamometer will be used to record the peak muscle force over three trials; the highest value will be used for analysis. Dynamometry is a reliable method for assessing strength (ICC=0.97).60 We will determine muscle strength ratios for abduction/adduction, internal/external rotation, and protraction/retraction.[14]
Measured: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Chronic Pain Coping Inventory-42 (CPCI-42)-Change over time
The CPCI, a 42-item abbreviated version of the original 65-item CPC [,6]1 asks individuals to self-report the frequency of use of particular behavioral and cognitive strategies to cope with pain; it has good psychometric properties.6[2] Specifically, the CPCI-42 lists coping strategies and asks participants "During the past week, how many days did you use each of the following at least once in the day to cope with your pain?" CPCI scales demonstrate adequate to excellent test-retest stability (0.65-0.90).
Measured: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Oct 2017
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Principal investigator, Margaret A. Finley, Drexel University
- Investigators
- Margaret A Finley, PT,PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137394
- Sponsor's protocol ID
- SC160041
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34282128Finley 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.
PubMed 32753624Finley 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.
PubMed 32796138
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Biopsychosocial Prospective Surveillance Model of Shoulder Pain in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03137394
- Acronym / sponsor ID
- SC160041
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, shoulder pain, psychosocial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | – | Other: ObservationParticipants 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 | – | Other: ObservationAge- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationData 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. | Other | Able-bodied control, Spinal Cord Injury |
Primary outcome
Musculoskeletal Pain Survey (MPS)-Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
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]
Pectoralis Minor Muscle Length Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
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]
Shoulder Girdle Tissue Integrity Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
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.
Tampa Scale of Kinesiophobia Scale (TSK-11)-Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
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]
Fear of Pain Questionnaire (FPQ)-Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
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]
Pain Catastrophizing Scale (PCS)-Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
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]
Subjective Quality of Life Questionnaire (SQoL)-Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
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.
2 secondary outcomes
Muscle Strength-Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Chronic Pain Coping Inventory-42 (CPCI-42)-Change over time
Time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 34282128Finley 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.
- Background: PubMed 32753624Finley 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.
- Background: PubMed 32796138Finley 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret A Finley, PT,PhD principal investigator
Drexel University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Drexel University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal Pain Survey (MPS)-Change over time (time frame: SCI Group: baseline, 6-months, one-year; Control Group: baseline, one-year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137394, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.