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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06278740
Other study ID # SCIUSG24
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 26, 2024
Est. completion date March 26, 2025

Study information

Verified date February 2024
Source Afyonkarahisar Health Sciences University
Contact Mahmut Sami DOGANLAR, MD
Phone +905512579828
Email mahmutdoganlar96@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 174
Est. completion date March 26, 2025
Est. primary completion date February 26, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Musculoskeletal Ultrasound
Upper extremity pathologies of participants with ultrasound

Locations

Country Name City State
Turkey Afyonkarahisar Health Sciences University Afyonkarahisar

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of US findings among participants 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 Visual Analog Scale (VAS) 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)
Secondary The Physical Examination of the Shoulder Scale (PESS) 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. 1 day (a single point in time)
Secondary The Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) 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)
Secondary American Spinal Injury Association (ASIA) Impairment Scale 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. 1 day (a single point in time)
Secondary The Spinal Cord Independence Measure (SCIM-III) 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)
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