Carpal Tunnel SyndromeNCT05983614
Effects of Body Structures and Function on Actıvıty and Partıcıpatıon in Patıents wıth Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2023to 15 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 25 to 55 years
- All sexes
- Adult
Study population: Patients who applied to the Physical Therapy Department of Kutahya Health Sciences University Hospital and were diagnosed with mild and moderate CTS according to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) will be invited to the study.
Who may be able to join
- Being diagnosed with mild-moderate CTS
- Being between the ages of 20-55
- Volunteering to participate in the study
Who cannot join
- Being diagnosed with severe CTS
- Have systemic inflammatory disease
- Having a disease that can cause polyneuropathy, such as diabetes mellitus
- Being receiving psychotherapy
- Illiteracy
- Have a hearing problem
- Have cognitive impairment
- Having a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Pain, Proprioception and Electrodiagnostic Findings on Activity and Participation in Patients With Idiopathic Carpal Tunnel Syndrome
The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation.
Read the detailed description
50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand pressure sensitivity measurement will be applied to the participants. In order to examine the relationship between body structure and functions (Pain, Sensation, EMG findings) and activity and participation with the AMOS program, the maximum likelihood method will be selected and a structural equation model (SEM) will be established.
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Pain, Proprioception, Sensation, EMG, ICF
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Leeds Assessment Neuropathic Symptoms and Signs (LANSS)
Leeds Assessment Neuropathic Symptoms and Signs (LANSS) scale is a clinical-based tool for identifying pain and patients with predominant neuropathic mechanisms.
Measured: 7 minutes
Boston Carpal Tunnel Questionnaire
It is a questionnaire used to evaluate symptom severity and functional status in individuals with carpal tunnel syndrome.
Measured: 12 minutes
Q-DASH
Q-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Measured: 10 minutes
Secondary outcomes (2)
Proprioception Assessment
Hand grip sensitivity will be measured with a dynamometer and hand pressure sensitivity will be measured with a Stabilizer Pressure Biofeedback (SBP) instrument.
Measured: 7 minutes
Visual Analog Scale
Evaluates the severity of pain, scoring between 0-10.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start5 Aug 2023
- Primary completion15 Oct 2023
- Study completion15 Dec 2024
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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Afsar, Kutahya Health Sciences University
- Investigators
- Emrah Afsar, Phd, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983614
- Sponsor's protocol ID
- 2022/16-2
- Status last verified
- May 2025
- First submitted
- 1 Aug 2023
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pain, Proprioception and Electrodiagnostic Findings on Activity and Participation in Patients With Idiopathic Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05983614
- Acronym / sponsor ID
- 2022/16-2
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Pain, Proprioception, Sensation, EMG, ICF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 9 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.
The aim of our study is to determine pain, sensation and electrodiagnostic findings in CTS; to examine its effects on activity and participation.
Detailed description
50 patients aged 20-55 years diagnosed with mild and moderate carpal tunnel syndrome according to AANEM will be included. VAS, LANSS, Boston Carpal Tunnel Questionnaire (Symptom Severity Scale - Functional Status Scale), Q-DASH, hand grip sensitivity measurement, hand pressure sensitivity measurement will be applied to the participants. In order to examine the relationship between body structure and functions (Pain, Sensation, EMG findings) and activity and participation with the AMOS program, the maximum likelihood method will be selected and a structural equation model (SEM) will be established.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients who applied to the Physical Therapy Department of Kutahya Health Sciences University Hospital and were diagnosed with mild and moderate CTS according to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) will be invited to the study.
Key inclusion criteria (3 listed)
- Being diagnosed with mild-moderate CTS
- Being between the ages of 20-55
- Volunteering to participate in the study
Key exclusion criteria (8 listed)
- Being diagnosed with severe CTS
- Have systemic inflammatory disease
- Having a disease that can cause polyneuropathy, such as diabetes mellitus
- Being receiving psychotherapy
- Illiteracy
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
Leeds Assessment Neuropathic Symptoms and Signs (LANSS)
Time frame: 7 minutes
Leeds Assessment Neuropathic Symptoms and Signs (LANSS) scale is a clinical-based tool for identifying pain and patients with predominant neuropathic mechanisms.
Boston Carpal Tunnel Questionnaire
Time frame: 12 minutes
It is a questionnaire used to evaluate symptom severity and functional status in individuals with carpal tunnel syndrome.
Q-DASH
Time frame: 10 minutes
Q-DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
2 secondary outcomes
Proprioception Assessment
Time frame: 7 minutes
Visual Analog Scale
Time frame: 2 minutes
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 23 May 2025.
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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.
Emrah Afsar, Phd principal investigator
Kutahya Health Sciences University
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 Kutahya Health Sciences 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 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 23 May 2025. 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?
Leeds Assessment Neuropathic Symptoms and Signs (LANSS) (time frame: 7 minutes). The study lists 3 primary outcomes in all. 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 23 May 2025.