ShoulderNCT06838247
Ultrasonographic Analysis of Post-Traumatic Shoulder Lesions After Hand Trauma
An observational study of Shoulder and Ultrasonographic, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to reveal whether there are concurrent shoulder lesions in patients with hand injuries. Its importance is that it will shed light on whether not only the hand but also the shoulder should be included in the treatment program in hand rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder, Ultrasonographic, Hand Injuries
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2024to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients who apply to our hand rehabilitation clinic for rehabilitation after hand injury will undergo a routine shoulder examination as well as a hand examination. The group with shoulder symptoms and examination findings will constitute the case group, and the group with a normal shoulder examination will constitute the control group. Age, gender, height, weight, occupation, dominant hand, type of injury, type of injury, duration of injury, operation time, and immobilization time will be recorded for both groups.
Who may be able to join
- Having a history of hand injury and applying for hand rehabilitation after surgical and conservative treatment.
Who cannot join
- Being under 18 and over 65 years of age
- Patients with systemic diseases (Diabetes mellitus, Peripheral vascular diseases)
- Any rheumatic disease involving the hand and upper extremity
- History of neuropathy involving the hand and upper extremity
- Those with any shoulder problems prior to the hand injury
- Those with an open wound on the hand
- Those who cannot cooperate
- Other upper extremity traumatic injuries occurring during the hand injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
Ankara, Altindag, 06230
Nadide Koca, M.D., +905376843434, nadide.koca@gmail.com
Cevriye Mülkoğlu, ASSOC PROF. M.D., +905327175597, drckaraca@hotmail.com
About this study
Official title: Detection of Simultaneous Presence of Shoulder Lesions in Patients With Hand Injuries by Diagnostic Ultrasonography
The purpose of the study is to reveal whether there are concurrent shoulder lesions in patients with hand injuries. Its importance is that it will shed light on whether not only the hand but also the shoulder should be included in the treatment program in hand rehabilitation.
Read the detailed description
Hand injuries constitute one fifth of the injuries that are brought to the emergency room and one third of the work accidents. They are very costly because they require surgical intervention and a long rehabilitation process and delay the patient's return to work. The general tendency in hand rehabilitation is to focus more on treatments focused on the hand and wrist.
There are studies that draw attention to the relationship between hand grip strength and rotator cuff function and that other upper extremity musculoskeletal injuries are often neglected in patients with hand injuries. This may affect rehabilitation results and prevent the patient from returning to daily activities.
It is reported that in patients with hand and wrist injuries, other upper extremity musculoskeletal problems are seen simultaneously in 40% of cases and most of these are related to the shoulder.
It is reported that rotator cuff problems and lateral epicondylitis are 9 times more common even in carpal tunnel syndrome, which is a relatively simple hand problem that is encountered very frequently in clinical practice.
Traumatic hand injuries can also affect all upper extremity functions. In these patients, it was determined that there was weakness in both the ipsilateral supraspinatus and infraspinatus muscles. The researchers emphasized that the inclusion of shoulder muscle training during the postoperative rehabilitation protocol and selective strengthening of the rotator cuff muscles in distal extremity problems may be clinically important.
In studies conducted to detect shoulder problems in patients with hand injuries, either patient examination or self-reports of the patients have been used so far.
In this study, the investigators aimed to concretely reveal shoulder pathologies by evaluating the results of diagnostic ultrasonography performed on our patients with shoulder symptoms. In this way, the investigators aimed to obtain a clearer result on whether the shoulder should be included in the hand rehabilitation program.
Our study is the first study to evaluate shoulder pathologies in patients with hand injuries with diagnostic ultrasonography.
- Conditions
- Shoulder, Ultrasonographic, Hand Injuries
- Keywords
- Hand injuries, Shoulder, Diagnostic, Ultrasonography
- Medical subject headings
- Hand Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients who apply to our hand rehabilitation clinic for rehabilitation after hand injury will undergo routine shoulder examination as well as hand examination. The group with shoulder symptoms and examination findings will constitute the case group. | |
| Control | The group with a normal shoulder examination and ultrasonographic findings will be the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic shoulder ultrasonography
For shoulder ultrasonography, the specialist physician and the patient will sit opposite each other. The examination will be performed using high-resolution linear probes. Standard ultrasonography technique and diagnosis will be used, and real-time ultrasonography will be performed with an ultrasound device with a 6-11 MHz linear wide-band probe (Nemio XH, Toshiba, Japan). In shoulder ultrasonography, the long head of the biceps brachialis muscle, supraspinatus tendon and subacromial bursa will be examined. Fluid increase or edema in the subacromial bursa will be evaluated to determine whether there is subacromial bursitis. In case of suspected supraspinatus tendon rupture, the contour integrity, echogenicity and thickness of the tendon will be carefully examined; in addition, it will be determined whether there is a partial or complete tear on the tendon.
Measured: up to 12 weeks
Secondary outcomes (4)
Visual analog scale (VAS) scores
VAS is used to convert some values that cannot be measured quantitatively into numerical values. In VAS, where pain intensity is evaluated, pain intensity is graded between 0 and 10 points. "No pain" is graded as 0 points and "very severe pain" is graded as 10 points. Pain intensity of "less than 3 points" is indicated as mild pain, "between 3-6 points" as moderate pain, and "more than 6 points" as severe pain.
Visual pain scoring will be done separately for both the hand and shoulder regions.
Measured: up to 12 weeks
Joint range of motion
Joint range of motion is known as ROM and refers to the measurement of the amount of movement around a specific joint. Joint range of motion will be measured with the help of a tool called a goniometer. Joint range of motion will be measured and recorded in both the hand joint and shoulder joint.
Measured: up to 12 weeks
Handgrip Strength Test
Grip strength is a measure of muscle strength or the maximum force/tension produced by a person's forearm muscles. It can be used as a screening tool for measuring upper body strength and general strength. Grip strength will be assessed with a Jamar dynamometer and the values obtained will be recorded.
Measured: up to 12 weeks
The Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index (SPADI) is a 13-item questionnaire divided into pain and activity limitation categories. It focuses on the degree of pain or disability caused by shoulder problems in the past week. The patient answers the questions himself/herself using a VAS or NRS scale. The higher a patient scores on the SPADI, the greater the pain/limitation in activities.
The score for each subscale is obtained by adding all individual scores for the subscale and dividing the result by the maximum score for the subscale. The normalized score is converted to a scale of 0 to 100, with 100 indicating severe problems and 0 indicating no problems.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start11 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ShoulderStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadide Koca, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838247
- Sponsor's protocol ID
- AnkaraTRH-FTR-NK-02
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdallah EA, Eldesoky MT, Saweres JW, Abdelhaleem MD. Effect of Adding Shoulder Stabilization Exercises to the Rehabilitation of Postoperative Hand Injuries in Young Adult Patients. Hand (N Y). 2025 Jul;20(5):778-784. doi: 10.1177/15589447241232017. Epub 2024 Feb 15.
PubMed 38357889Winiarski LM, Livoni JD, Madsen PV, Rathleff MS, Larsen P. Concurrent musculoskeletal complaints in elbows, shoulders, and necks after common hand and forearm injuries or conditions: A cross-sectional study among 600 patients. J Hand Ther. 2021 Oct-Dec;34(4):543-548. doi: 10.1016/j.jht.2020.05.002. Epub 2020 Sep 4.
PubMed 32893097Horsley I, Herrington L, Hoyle R, Prescott E, Bellamy N. Do changes in hand grip strength correlate with shoulder rotator cuff function? Shoulder Elbow. 2016 Apr;8(2):124-9. doi: 10.1177/1758573215626103. Epub 2016 Jan 25.
PubMed 27583010Xue R, Wong J, Imere A, King H, Clegg P, Cartmell S. Current clinical opinion on surgical approaches and rehabilitation of hand flexor tendon injury-a questionnaire study. Front Med Technol. 2024 Feb 15;6:1269861. doi: 10.3389/fmedt.2024.1269861. eCollection 2024.
PubMed 38425421Jha CK, Shukla Y, Mukherjee R, Rathva P, Joshi M, Jain D. A Glove-Based Virtual Hand Rehabilitation System for Patients With Post-Traumatic Hand Injuries. IEEE Trans Biomed Eng. 2024 Jul;71(7):2033-2041. doi: 10.1109/TBME.2024.3360888. Epub 2024 Jun 19.
PubMed 38294922
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Simultaneous Presence of Shoulder Lesions in Patients With Hand Injuries by Diagnostic Ultrasonography
- ClinicalTrials.gov ID
- NCT06838247
- Acronym / sponsor ID
- AnkaraTRH-FTR-NK-02
- Conditions
- Shoulder, Ultrasonographic, Hand Injuries
- Keywords
- Hand injuries, Shoulder, Diagnostic, Ultrasonography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 20 Feb 2025 (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.
The purpose of the study is to reveal whether there are concurrent shoulder lesions in patients with hand injuries. Its importance is that it will shed light on whether not only the hand but also the shoulder should be included in the treatment program in hand rehabilitation.
Detailed description
Hand injuries constitute one fifth of the injuries that are brought to the emergency room and one third of the work accidents. They are very costly because they require surgical intervention and a long rehabilitation process and delay the patient's return to work. The general tendency in hand rehabilitation is to focus more on treatments focused on the hand and wrist.
There are studies that draw attention to the relationship between hand grip strength and rotator cuff function and that other upper extremity musculoskeletal injuries are often neglected in patients with hand injuries. This may affect rehabilitation results and prevent the patient from returning to daily activities.
It is reported that in patients with hand and wrist injuries, other upper extremity musculoskeletal problems are seen simultaneously in 40% of cases and most of these are related to the shoulder.
It is reported that rotator cuff problems and lateral epicondylitis are 9 times more common even in carpal tunnel syndrome, which is a relatively simple hand problem that is encountered very frequently in clinical practice.
Traumatic hand injuries can also affect all upper extremity functions. In these patients, it was determined that there was weakness in both the ipsilateral supraspinatus and infraspinatus muscles. The researchers emphasized that the inclusion of shoulder muscle training during the postoperative rehabilitation protocol and selective strengthening of the rotator cuff muscles in distal extremity problems may be clinically important.
In studies conducted to detect shoulder problems in patients with hand injuries, either patient examination or self-reports of the patients have been used so far.
In this study, the investigators aimed to concretely reveal shoulder pathologies by evaluating the results of diagnostic ultrasonography performed on our patients with shoulder symptoms. In this way, the investigators aimed to obtain a clearer result on whether the shoulder should be included in the hand rehabilitation program.
Our study is the first study to evaluate shoulder pathologies in patients with hand injuries with diagnostic ultrasonography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients who apply to our hand rehabilitation clinic for rehabilitation after hand injury will undergo routine shoulder examination as well as hand examination. The group with shoulder symptoms and examination findings will constitute the case group. |
| Control | – | –The group with a normal shoulder examination and ultrasonographic findings will be the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who apply to our hand rehabilitation clinic for rehabilitation after hand injury will undergo a routine shoulder examination as well as a hand examination. The group with shoulder symptoms and examination findings will constitute the case group, and the group with a normal shoulder examination will constitute the control group. Age, gender, height, weight, occupation, dominant hand, type of injury, type of injury, duration of injury, operation time, and immobilization time will be recorded for both groups.
Key inclusion criteria (1 listed)
- Having a history of hand injury and applying for hand rehabilitation after surgical and conservative treatment.
Key exclusion criteria (8 listed)
- Being under 18 and over 65 years of age
- Patients with systemic diseases (Diabetes mellitus, Peripheral vascular diseases)
- Any rheumatic disease involving the hand and upper extremity
- History of neuropathy involving the hand and upper extremity
- Those with any shoulder problems prior to the hand injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic shoulder ultrasonography
Time frame: up to 12 weeks
For shoulder ultrasonography, the specialist physician and the patient will sit opposite each other. The examination will be performed using high-resolution linear probes. Standard ultrasonography technique and diagnosis will be used, and real-time ultrasonography will be performed with an ultrasound device with a 6-11 MHz linear wide-band probe (Nemio XH, Toshiba, Japan). In shoulder ultrasonography, the long head of the biceps brachialis muscle, supraspinatus tendon and subacromial bursa will be examined. Fluid increase or edema in the subacromial bursa will be evaluated to determine whether there is subacromial bursitis. In case of suspected supraspinatus tendon rupture, the contour integrity, echogenicity and thickness of the tendon will be carefully examined; in addition, it will be determined whether there is a partial or complete tear on the tendon.
4 secondary outcomes
Visual analog scale (VAS) scores
Time frame: up to 12 weeks
Joint range of motion
Time frame: up to 12 weeks
Handgrip Strength Test
Time frame: up to 12 weeks
The Shoulder Pain and Disability Index
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 38357889Abdallah EA, Eldesoky MT, Saweres JW, Abdelhaleem MD. Effect of Adding Shoulder Stabilization Exercises to the Rehabilitation of Postoperative Hand Injuries in Young Adult Patients. Hand (N Y). 2025 Jul;20(5):778-784. doi: 10.1177/15589447241232017. Epub 2024 Feb 15.
- Background: PubMed 32893097Winiarski LM, Livoni JD, Madsen PV, Rathleff MS, Larsen P. Concurrent musculoskeletal complaints in elbows, shoulders, and necks after common hand and forearm injuries or conditions: A cross-sectional study among 600 patients. J Hand Ther. 2021 Oct-Dec;34(4):543-548. doi: 10.1016/j.jht.2020.05.002. Epub 2020 Sep 4.
- Background: PubMed 27583010Horsley I, Herrington L, Hoyle R, Prescott E, Bellamy N. Do changes in hand grip strength correlate with shoulder rotator cuff function? Shoulder Elbow. 2016 Apr;8(2):124-9. doi: 10.1177/1758573215626103. Epub 2016 Jan 25.
- Background: PubMed 38425421Xue R, Wong J, Imere A, King H, Clegg P, Cartmell S. Current clinical opinion on surgical approaches and rehabilitation of hand flexor tendon injury-a questionnaire study. Front Med Technol. 2024 Feb 15;6:1269861. doi: 10.3389/fmedt.2024.1269861. eCollection 2024.
- Background: PubMed 38294922Jha CK, Shukla Y, Mukherjee R, Rathva P, Joshi M, Jain D. A Glove-Based Virtual Hand Rehabilitation System for Patients With Post-Traumatic Hand Injuries. IEEE Trans Biomed Eng. 2024 Jul;71(7):2033-2041. doi: 10.1109/TBME.2024.3360888. Epub 2024 Jun 19.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder and Ultrasonographic, run by Ankara Training and Research Hospital at 1 site 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadide Koca, M.D. (+905376843434, nadide.koca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic shoulder ultrasonography (time frame: up to 12 weeks). 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 NCT06838247, which also lists 5 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 6 Aug 2026.