Spinal Cord InjuriesNCT06278740
Upper Extremity Pathologies in Spinal Cord Injuries
An observational study of Spinal Cord Injuries and Upper Extremity Problem, run by Afyonkarahisar Health Sciences University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Upper Extremity Problem, Musculoskeletal Pain
- What is being tested?
- Musculoskeletal Ultrasound
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Aug 2024to 4 Oct 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spinal cord injuries who use manual wheelchairs and spinal cord injuries who do not use manual wheelchairs, aged between 18-65 years who applied to our clinic will be included in the study.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Afyonkarahisar
Afyonkarahisar, Afyonkarahisar, 0300
Afyonkarahisar Health Sciences University
Afyonkarahisar, Afyonkarahisar, 03100
About this study
Official title: Investigation of Upper Extremity Pathologies and Associated Factors in Patients With Spinal Cord Injuries
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.
Read the 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.
- Being tested
- Musculoskeletal Ultrasound
- Medical subject headings
- Spinal Cord Injuries, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal UltrasoundDiagnostic test
Upper extremity pathologies of participants with ultrasound
| Study group | Role | What they receive |
|---|---|---|
| SCI with Manual Wheelchair Usage | Patients with spinal cord injuries who use manual wheelchairs Receives: Diagnostic Test: Musculoskeletal Ultrasound | |
| SCI without Manual Wheelchair Usage | Patients with spinal cord injuries who do not use manual wheelchairs Receives: Diagnostic Test: Musculoskeletal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of US findings among participants
Ultrasonographic evaluation of upper extremity shoulder, elbow and wrist pathologies and examination of their relationship with clinical parameters.
Measured: 1 day (a single point in time)
Secondary outcomes (5)
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.
Measured: 1 day (a single point in time)
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.
Measured: 1 day (a single point in time)
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.
Measured: 1 day (a single point in time)
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.
Measured: 1 day (a single point in time)
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.
Measured: 1 day (a single point in time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start5 Aug 2024
- Primary completion4 Oct 2025
- Study completion4 Oct 2025
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 InjuriesStudies 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami Doğanlar, Afyonkarahisar Health Sciences University
- Investigators
- Mahmut Sami DOĞANLAR, MD, Principal investigator, Afyonkarahisar Health Sciences UniversityNuran EYVAZ, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278740
- Sponsor's protocol ID
- SCIUSG24
- Status last verified
- Aug 2024
- First submitted
- 19 Feb 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37256679Collinger 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.
PubMed 20407304Vives 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.
PubMed 33814884
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Upper Extremity Pathologies and Associated Factors in Patients With Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT06278740
- Acronym / sponsor ID
- SCIUSG24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Oct 2025 (actual)
- First posted
- 26 Feb 2024 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI with Manual Wheelchair Usage | – | Diagnostic Test: Musculoskeletal UltrasoundPatients with spinal cord injuries who use manual wheelchairs |
| SCI without Manual Wheelchair Usage | – | Diagnostic Test: Musculoskeletal UltrasoundPatients with spinal cord injuries who do not use manual wheelchairs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spinal cord injuries who use manual wheelchairs and spinal cord injuries who do not use manual wheelchairs, aged between 18-65 years who applied to our clinic will be included in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Tetraplegia
- A significant comorbid condition such as severe heart disease and uncontrolled hypertension.
- Cognitive dysfunction
- Active infection
- Malignancy
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 |
|---|---|---|
| Musculoskeletal UltrasoundUpper extremity pathologies of participants with ultrasound | Diagnostic test | SCI with Manual Wheelchair Usage, SCI without Manual Wheelchair Usage |
Primary outcome
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.
5 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 1 day (a single point in time)
The Physical Examination of the Shoulder Scale (PESS)
Time frame: 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)
American Spinal Injury Association (ASIA) Impairment Scale
Time frame: 1 day (a single point in time)
The Spinal Cord Independence Measure (SCIM-III)
Time frame: 1 day (a single point in time)
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 8 Dec 2025.
- Background: PubMed 37256679Ata 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.
- Background: PubMed 20407304Collinger 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.
- Background: PubMed 33814884Vives 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.
- Relationship Between Manual Wheelchair Using Skills and Upper Limb Musculoskeletal Disorders in Patients With Spinal Cord Injury: A Musculoskeletal Ultrasonography StudyLink provided by the sponsor.
- Validation of Greyscale-Based Quantitative Ultrasound in Manual Wheelchair UsersLink provided by the sponsor.
- Upper Extremity Overuse Injuries and Obesity After Spinal Cord InjuryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mahmut Sami DOĞANLAR, MD principal investigator
Afyonkarahisar Health Sciences University
Nuran EYVAZ, MD principal investigator
Afyonkarahisar Health Sciences 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 Injuries and Upper Extremity Problem, run by Afyonkarahisar Health Sciences University at 2 sites in Turkey (Türkiye).
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 1 inclusion and 8 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 8 Dec 2025. 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 Turkey (Türkiye). 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?
Comparison of US findings among participants (time frame: 1 day (a single point in time)). 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 NCT06278740, 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 8 Dec 2025.