Ulnar NeuropathiesNCT05175209
The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions.
A study testing EMG in people with Ulnar Neuropathies, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Regardless of the cause of ulnar nerve entrapment neuropathy, investigators are planning to explore the relationship between the ipsilateral upper extremity dysfunction that may develop due to ulnar neuropathy and the level of entrapment in electromyelography. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulnar Neuropathies
- What is being tested?
- EMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2022to 27 Apr 2022
- Phase
- Interventional
- 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
Who may be able to join
- having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)
- to be between the ages of 18-65
- be give informed consent
Who cannot join
- inflammatory arthritis
- hemiplegia
- contractures of shoulder-arm-hand joints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions in Patients With Ulnar Nerve Entrapment Neuropathy.
Regardless of the cause of ulnar nerve entrapment neuropathy, investigators are planning to explore the relationship between the ipsilateral upper extremity dysfunction that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.
- Conditions
- Ulnar Neuropathies
- Being tested
- EMG
- Medical subject headings
- Ulnar Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMGDiagnostic test
Electromyelography
| Study group | Role | What they receive |
|---|---|---|
| Electromyelography | Other | EMG will be performed only once to determine the ulnar nerve entrapment site in patients. Receives: Diagnostic Test: EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH) score
Evaluation of upper extremity function between 0 and 100 points, higher scores mean a worse outcome.
Measured: 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start19 Jan 2022
- Primary completion20 Mar 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar NeuropathiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175209
- Sponsor's protocol ID
- Hundredth Year University
- Status last verified
- Apr 2022
- First submitted
- 13 Dec 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions in Patients With Ulnar Nerve Entrapment Neuropathy.
- ClinicalTrials.gov ID
- NCT05175209
- Acronym / sponsor ID
- Hundredth Year University
- Conditions
- Ulnar Neuropathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 3 Jan 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.
Regardless of the cause of ulnar nerve entrapment neuropathy, investigators are planning to explore the relationship between the ipsilateral upper extremity dysfunction that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electromyelography | Other | Diagnostic Test: EMGEMG will be performed only once to determine the ulnar nerve entrapment site in patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)
- to be between the ages of 18-65
- be give informed consent
Key exclusion criteria (3 listed)
- inflammatory arthritis
- hemiplegia
- contractures of shoulder-arm-hand joints
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 |
|---|---|---|
| EMGElectromyelography | Diagnostic test | Electromyelography |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: 10 minutes.
Evaluation of upper extremity function between 0 and 100 points, higher scores mean a worse outcome.
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 28 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG in people with Ulnar Neuropathies, run by Yuzuncu Yil University 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 3 inclusion and 3 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 28 Apr 2022. 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?
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?
Disabilities of the Arm, Shoulder and Hand (DASH) score (time frame: 10 minutes.). 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 28 Apr 2022.