Carpal Tunnel SyndromeNCT05970692
Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
An observational study of Carpal Tunnel Syndrome, run by Ilke KARA at 1 site in Turkey (Türkiye).
Trial summary
This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Sep 2023to 30 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: CTS patients aged between 18-65 years old
Who may be able to join
- Aged between 18-65 years old,
- Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month,
- Assessed through provocation tests and physical examination to match the median nerve distribution.
Who cannot join
- Not willing to participate in the study,
- Clinical or electrophysiological signs of proximal nerve compression,
- Diabetes or other metabolic disease,
- Rheumatoid arthritis or other general inflammatory diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bitlis Eren University
Bitlis, 13000
Tülay Çevik Saldıran, PhD, +90 (434) 222 83 32, tcsaldiran@beu.edu.tr
About this study
This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Pain
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
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 |
|---|---|---|
| Healthy Controls | Healthy individuals aged between 18-65 years old | |
| CTS Group | CTS patients aged between 18-65 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atroshi-Lyrén 6-item symptoms scale
The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start26 Sep 2023
- Primary completion13 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilke KARA
- Sponsor type
- University, hospital or other
- Collaborators
- Bitlis Eren University
- Responsible party
- Sponsor-investigator, Ilke KARA, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970692
- Sponsor's protocol ID
- BEU-KTS-01
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
- ClinicalTrials.gov ID
- NCT05970692
- Acronym / sponsor ID
- BEU-KTS-01
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ilke KARAUniversity, hospital or other
- Collaborators
- Bitlis Eren University
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 13 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Aug 2023 (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 develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –Healthy individuals aged between 18-65 years old |
| CTS Group | – | –CTS patients aged between 18-65 years old |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CTS patients aged between 18-65 years old
Key inclusion criteria (3 listed)
- Aged between 18-65 years old,
- Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month,
- Assessed through provocation tests and physical examination to match the median nerve distribution.
Key exclusion criteria (4 listed)
- Not willing to participate in the study,
- Clinical or electrophysiological signs of proximal nerve compression,
- Diabetes or other metabolic disease,
- Rheumatoid arthritis or other general inflammatory diseases.
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
Atroshi-Lyrén 6-item symptoms scale
Time frame: 1 week
The A-L scale consists of 6 items that inquire about severity and frequency of night and daytime numbness and tingling and pain. For each patient the item responses are scored from 1 (best) to5 (worst) and then averaged for the 6 items to yield a total score (only 1 missing item response is allowed)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Carpal Tunnel Syndrome, run by Ilke KARA 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 4 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 22 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tülay Çevik Saldıran, PhD (+90 (434) 222 83 32, tcsaldiran@beu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atroshi-Lyrén 6-item symptoms scale (time frame: 1 week). 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 22 Feb 2024.