- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06278740
Upper Extremity Pathologies in Spinal Cord Injuries
Investigation of Upper Extremity Pathologies and Associated Factors in Patients With Spinal Cord Injuries
Study Overview
Status
Intervention / Treatment
Detailed Description
Spinal cord injury is a neurological condition that can result from traumatic or non-traumatic causes, leading to motor, sensory and autonomic dysfunctions. Following a spinal cord injury, the upper extremity becomes increasingly used for mobility, weight-bearing, and transfer activities, making functionality crucial in daily life. Wheelchairs, commonly used by individuals with spinal cord injuries for daily activities, can lead to injuries and pain or degeneration in the upper extremities due to repetitive transfer activities. As a result, individuals with spinal cord injuries are at high risk for shoulder, elbow, wrist and hand injuries. Neuromuscular ultrasound (NMUS) has become increasingly important in clinical use in the evaluation of peripheral nerves and muscles in patients with spinal cord injuries in recent years, due to the advantages of ultrasonography such as providing dynamic and real-time evaluation, not containing radiation, and being painless.
This study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Afyonkarahisar
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Afyonkarahisar, Afyonkarahisar, Turkey (Türkiye), 0300
- Afyonkarahisar
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Afyonkarahisar, Afyonkarahisar, Turkey (Türkiye), 03100
- Afyonkarahisar Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who have experienced spinal cord injury, can comply with two-stage verbal commands, voluntarily agree to participate in the study and are medically stable.
Exclusion Criteria:
- Tetraplegia
- A significant comorbid condition such as severe heart disease and uncontrolled hypertension.
- Cognitive dysfunction
- Active infection
- Malignancy
- History of trauma to the upper extremity
- Brachial plexus and peripheral nerve injury
- History of surgery on the upper extremity
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SCI with Manual Wheelchair Usage
Patients with spinal cord injuries who use manual wheelchairs
|
Upper extremity pathologies of participants with ultrasound
|
|
SCI without Manual Wheelchair Usage
Patients with spinal cord injuries who do not use manual wheelchairs
|
Upper extremity pathologies of participants with ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of US findings among participants
Time Frame: 1 day (a single point in time)
|
Ultrasonographic evaluation of upper extremity shoulder, elbow and wrist pathologies and examination of their relationship with clinical parameters.
|
1 day (a single point in time)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: 1 day (a single point in time)
|
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
|
1 day (a single point in time)
|
|
The Physical Examination of the Shoulder Scale (PESS)
Time Frame: 1 day (a single point in time)
|
Includes 10 specific shoulder examination methods (Neer test, Hawkins test, Painful arc test, Supraspinatus test, Speed test, Yergason's test, O'brien test, Gerber's lift-off test, Horizontal adduction test, 0-degree abduction test).
For each test, if there is no pain, 0 points are given; if there is suspected pain, 1 point is given; if there is obvious pain described during the test, 2 points are given.
The maximum score for a single shoulder is 20 points.
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1 day (a single point in time)
|
|
The Quick Disability of the Arm, Shoulder, and Hand (Quick DASH)
Time Frame: 1 day (a single point in time)
|
Quick DASH is a rapid, practical, and frequently used scale that allows the evaluation of the functional and symptomatic status of patients with upper extremity problems.
The questionnaire consists of 11 questions, with 5 options provided for each question.
A higher score indicates more activity limitation and greater difficulty.
|
1 day (a single point in time)
|
|
American Spinal Injury Association (ASIA) Impairment Scale
Time Frame: 1 day (a single point in time)
|
ASIA assessment consists of two parts: motor and sensory.
Motor assessment involves testing the strength of ten key muscles on each side of the body in the supine position (ranging from 0 = no contraction to 5 = normal resistance).
The maximum score for the upper extremities and lower extremities is 50.
Sensory evaluation includes testing pinprick and light touch sensation.
Pinprick and light touch sensations are scored separately for each dermatome on a 3-point scale (0, 1, and 2).
Total highest score is 224, higher score indicates better.
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1 day (a single point in time)
|
|
The Spinal Cord Independence Measure (SCIM-III)
Time Frame: 1 day (a single point in time)
|
Reliable tool for measuring the level of independence following spinal cord injury (SCI).
The total score ranges from 0 to 100 and comprises sub-items such as Personal Care (0-20), Respiration and Sphincter Management (0-40), and Mobility (0-40).
Lower scores indicate decreased levels of independence.
|
1 day (a single point in time)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nuran EYVAZ, MD, Afyonkarahisar Health Sciences University
- Principal Investigator: Mahmut Sami DOĞANLAR, MD, Afyonkarahisar Health Sciences University
Publications and helpful links
General Publications
- Ata AM, Mete Civelek G, Kara O. Relationship Between Manual Wheelchair Using Skills and Upper Limb Musculoskeletal Disorders in Patients With Spinal Cord Injury: A Musculoskeletal Ultrasonography Study. Am J Phys Med Rehabil. 2023 Nov 1;102(11):959-964. doi: 10.1097/PHM.0000000000002296. Epub 2023 May 23.
- Collinger JL, Fullerton B, Impink BG, Koontz AM, Boninger ML. Validation of grayscale-based quantitative ultrasound in manual wheelchair users: relationship to established clinical measures of shoulder pathology. Am J Phys Med Rehabil. 2010 May;89(5):390-400. doi: 10.1097/PHM.0b013e3181d8a238.
- Vives Alvarado JR, Felix ER, Gater DR Jr. Upper Extremity Overuse Injuries and Obesity After Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2021;27(1):68-74. doi: 10.46292/sci20-00061.
Helpful Links
- Relationship Between Manual Wheelchair Using Skills and Upper Limb Musculoskeletal Disorders in Patients With Spinal Cord Injury: A Musculoskeletal Ultrasonography Study
- Validation of Greyscale-Based Quantitative Ultrasound in Manual Wheelchair Users
- Upper Extremity Overuse Injuries and Obesity After Spinal Cord Injury
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCIUSG24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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