Tendon DisorderNCT05323643
Role of US in Evaluation of Tendon and Ligament Abnormalities in Hand and Fingers
An observational study of Tendon Disorder, run by Assiut University.
Trial summary
Assessment of the role of USG in the evaluation of tendon and ligament abnormalities in hand and fingers in traumatic \& non-traumatic causes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tendon Disorder
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients complaining of pain or masses in hands or fingers, patients with inflammatory conditions, and traumatic injuries.
Who may be able to join
- Patients complaining of pain or masses of the hands and the fingers or referred for assessment of tendon \& ligaments which are involved in such pain and swellings.
Who cannot join
- Patients with a recent history of local operative intervention will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Ultrasound in Evaluation of Tendon and Ligament Abnormalities in Hand and Fingers
Assessment of the role of USG in the evaluation of tendon and ligament abnormalities in hand and fingers in traumatic \& non-traumatic causes.
Read the detailed description
The hand and fingers are the most important functional parts of the body in daily life activities and are prone to traumatic injuries and susceptible to a wide array of inflammatory diseases. Tendon abnormalities of the hand and the fingers are common disorders, particularly among athletes and in the elderly. These abnormalities may be symptomatic degenerative changes, inflammatory, or rupture. Tendon disorders are a common cause of pain and loss of function. Chronic tendon disorders are much more common than acute injuries and are the result of overuse or age-related tendon degeneration.
There is a wide spectrum of hand and finger pathological conditions that can be demonstrated using Ultrasonography. Superficial structures of the wrist, hand, and fingers, including the tendons, ligaments, nerves, and vessels, are amenable to imaging with high-frequency US. US can depict masses and fluid collections, help locate radiolucent foreign bodies, characterize traumatic or overuse tendon or ligament pathology, and help evaluate compressive peripheral neuropathy and microvascular blood flow. Additionally, this modality improves the accuracy of therapeutic intra-articular or peritendinous injections and facilitates aspiration of fluid collections, such as ganglia.
Due to the improvement of imaging techniques in the last years, the performance of ultrasonography (US) in detecting pathological changes in the musculoskeletal system dramatically increased. Moreover, dynamic examination allows better evaluation of the type and extension of the lesions. An anatomical course of the nerves and tendons can be depicted by US, thus offering valuable information on the exact location and type of possible lesions.
The role of USG in the assessment of tendon disorders is steadily increasing due to its being low cost, fast, wide-spread availability, and non-invasive. Additionally, it may offer a dynamic assessment of the flexor and extensor tendons, collateral ligaments, and supporting structures of the fingers, such as the extensor hood and the volar plate, as well as space-occupying lesions.
The quality of USG assessment of anatomical structures in the hand has highly improved over the last time. The development of high resolution with the highest possible frequency of modern ultrasound equipment and the superficial location of most tendons allows the spectrum of tendon abnormalities to be easily depicted with USG. US facilitates dynamic, real-time evaluation of bones, joints, tendons, nerves, and vessels, making it an ideal imaging modality for hand and finger conditions.
- Conditions
- Tendon Disorder
- Being tested
- Ultrasound
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
musculoskeletal US will be performed using commercially -available equipment, with high frequency linear -array transducers and a standard gel interface. The higher frequency transducers provide better spatial resolution, while the lower frequency transducers provide a greater depth of tissue penetrance. Colour Doppler US is also performed in most cases as it plays an important role in supporting and confirming diagnoses, by providing valuable information about the pathophysiology of the abnormality.
The patients will be seated with hands placed on a table, to permit examination of both volar and dorsal aspects, in longitudinal and transversal axis. Examination of the hands and fingers usually requires a large amount of transmission gel, in order to avoid compression and to permit dynamic evaluation. When acute trauma with skin lesions is investigated, sterile transmission gel, or sterile acoustic standoff pads can be used
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the tendon and ligament abnormalities by the US and correlating them with the symptoms.
characterization of tendon and ligament pathologies in hand and fingers in traumatic and non-traumatic causes by using clinical history and imaging appearance by US, one can determine the diagnosis
Measured: Baseline
Secondary outcomes (1)
Assessment of the role of USG in the evaluation of tendon and ligament abnormalities in hand and fingers.
help in the diagnosis of different hand and finger diseases, view of reliability and sensitivity: specificity ratio in assessing tendon and ligament diseases in hand and fingers either in inflammatory conditions or traumatic injuries
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Dec 2022 (estimated)
- Primary completion11 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Ahmed Sayed Mohamed Sebaie, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323643
- Sponsor's protocol ID
- US in hand & fingers
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound in Evaluation of Tendon and Ligament Abnormalities in Hand and Fingers
- ClinicalTrials.gov ID
- NCT05323643
- Acronym / sponsor ID
- US in hand & fingers
- Conditions
- Tendon Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 11 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Apr 2022 (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.
Assessment of the role of USG in the evaluation of tendon and ligament abnormalities in hand and fingers in traumatic \& non-traumatic causes.
Detailed description
The hand and fingers are the most important functional parts of the body in daily life activities and are prone to traumatic injuries and susceptible to a wide array of inflammatory diseases. Tendon abnormalities of the hand and the fingers are common disorders, particularly among athletes and in the elderly. These abnormalities may be symptomatic degenerative changes, inflammatory, or rupture. Tendon disorders are a common cause of pain and loss of function. Chronic tendon disorders are much more common than acute injuries and are the result of overuse or age-related tendon degeneration.
There is a wide spectrum of hand and finger pathological conditions that can be demonstrated using Ultrasonography. Superficial structures of the wrist, hand, and fingers, including the tendons, ligaments, nerves, and vessels, are amenable to imaging with high-frequency US. US can depict masses and fluid collections, help locate radiolucent foreign bodies, characterize traumatic or overuse tendon or ligament pathology, and help evaluate compressive peripheral neuropathy and microvascular blood flow. Additionally, this modality improves the accuracy of therapeutic intra-articular or peritendinous injections and facilitates aspiration of fluid collections, such as ganglia.
Due to the improvement of imaging techniques in the last years, the performance of ultrasonography (US) in detecting pathological changes in the musculoskeletal system dramatically increased. Moreover, dynamic examination allows better evaluation of the type and extension of the lesions. An anatomical course of the nerves and tendons can be depicted by US, thus offering valuable information on the exact location and type of possible lesions.
The role of USG in the assessment of tendon disorders is steadily increasing due to its being low cost, fast, wide-spread availability, and non-invasive. Additionally, it may offer a dynamic assessment of the flexor and extensor tendons, collateral ligaments, and supporting structures of the fingers, such as the extensor hood and the volar plate, as well as space-occupying lesions.
The quality of USG assessment of anatomical structures in the hand has highly improved over the last time. The development of high resolution with the highest possible frequency of modern ultrasound equipment and the superficial location of most tendons allows the spectrum of tendon abnormalities to be easily depicted with USG. US facilitates dynamic, real-time evaluation of bones, joints, tendons, nerves, and vessels, making it an ideal imaging modality for hand and finger conditions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients complaining of pain or masses in hands or fingers, patients with inflammatory conditions, and traumatic injuries.
Key inclusion criteria (1 listed)
- Patients complaining of pain or masses of the hands and the fingers or referred for assessment of tendon \& ligaments which are involved in such pain and swellings.
Key exclusion criteria (1 listed)
- Patients with a recent history of local operative intervention will be excluded
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 |
|---|---|---|
| Ultrasoundmusculoskeletal US will be performed using commercially -available equipment, with high frequency linear -array transducers and a standard gel interface. The higher frequency transducers provide better spatial resolution, while the lower frequency transducers provide a greater depth of tissue penetrance. Colour Doppler US is also performed in most cases as it plays an important role in supporting and confirming diagnoses, by providing valuable information about the pathophysiology of the abnormality. The patients will be seated with hands placed on a table, to permit examination of both volar and dorsal aspects, in longitudinal and transversal axis. Examination of the hands and fingers usually requires a large amount of transmission gel, in order to avoid compression and to permit dynamic evaluation. When acute trauma with skin lesions is investigated, sterile transmission gel, or sterile acoustic standoff pads can be used | Device | – |
Primary outcome
Evaluating the tendon and ligament abnormalities by the US and correlating them with the symptoms.
Time frame: Baseline
characterization of tendon and ligament pathologies in hand and fingers in traumatic and non-traumatic causes by using clinical history and imaging appearance by US, one can determine the diagnosis
1 secondary outcome
Assessment of the role of USG in the evaluation of tendon and ligament abnormalities in hand and fingers.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendon Disorder, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wafaa Ahmed, Master degree (01068066176, Wafaa.20134481@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the tendon and ligament abnormalities by the US and correlating them with the symptoms. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022.