Carpal Tunnel SyndromeNCT06635109
Investigating the Effect of Carpal Tunnel Syndrome on Activity and Participation
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 was to examine the effect of different severities of Carpal Tunnel Syndrome on activity and participation within the framework of the International Classification of Functioning, Disability and Health (ICF). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included.
Who may be able to join
- Diagnosis of CTS in the dominant hand
- Being between the ages of 18-65
- Volunteering to participate in the study
Who cannot join
- Having systemic inflammatory disease
- Having a disease that may cause polyneuropathy such as diabetes mellitus
- Having a pacemaker
- Having a disease affecting the central nervous system
- Having cervical radiculopathy
- History of previous operation or local steroid injection due to CTS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Different Severities of Carpal Tunnel Syndrome on Activity and Participation
The aim of our study was to examine the effect of different severities of Carpal Tunnel Syndrome on activity and participation within the framework of the International Classification of Functioning, Disability and Health (ICF).
Read the detailed description
Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included. SF-36, Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH), Michigan Hand Outcomes Questionnaire and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used to assess activity and participation. The questionnaires will be filled out via Google Forms. Shapiro-Wilk test will be performed to determine the distribution of the data. Whether the dependent variables differ between groups will be analysed by One-way ANOVA (continuous). For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.
- Conditions
- Carpal Tunnel Syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
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 |
|---|---|---|
| Mild carpal tunnel syndrome | Not described | |
| Middle carpal tunnel syndrome | Not described | |
| Severe carpal tunnel syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form - 36 Quality of Life Questionnaire (SF-36)
SF-36 is a health-related quality of life questionnaire consisting of 8 scales (physical functioning, role limitations due to physical health problems, pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health). Responses to items are converted into scale scores from 0 (worst health) to 100 (best health).
Measured: 15 minutes
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)
Each question in the scale is scored between 1 and 5. The results range from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms).
Measured: 10 minutes
Michigan Hand Questionnaire (MHQ)
The Michigan Hand Questionnaire (MHQ) is a hand-specific questionnaire that measures the health status of patients with acute and chronic hand disorders. The MHQ is an outcome tool consisting of 37 questions and 6 domains: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with function. Each domain is scored using an unweighted method by summing the responses on each scale (1 to 5) and normalising the scores to a scale from 0 to 100. A lower score indicates more severe disability, other than pain. The final score is obtained by averaging the six scores after inverting the pain score.
Measured: 15 minutes
Boston Carpal Tunnel Questionnaire - Functional Status Scale
It is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Nov 2024
- Primary completion10 Jan 2026
- Study completion15 Jan 2026
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.
- More trials run by Kutahya Health Sciences 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
- Prospective
- Enrolment
- 156 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635109
- Sponsor's protocol ID
- 2024-a
- Status last verified
- Mar 2026
- First submitted
- 8 Oct 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Different Severities of Carpal Tunnel Syndrome on Activity and Participation
- ClinicalTrials.gov ID
- NCT06635109
- Acronym / sponsor ID
- 2024-a
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 10 Oct 2024 (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 was to examine the effect of different severities of Carpal Tunnel Syndrome on activity and participation within the framework of the International Classification of Functioning, Disability and Health (ICF).
Detailed description
Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included. SF-36, Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH), Michigan Hand Outcomes Questionnaire and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used to assess activity and participation. The questionnaires will be filled out via Google Forms. Shapiro-Wilk test will be performed to determine the distribution of the data. Whether the dependent variables differ between groups will be analysed by One-way ANOVA (continuous). For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild carpal tunnel syndrome | – | – |
| Middle carpal tunnel syndrome | – | – |
| Severe carpal tunnel syndrome | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included.
Key inclusion criteria (3 listed)
- Diagnosis of CTS in the dominant hand
- Being between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Having systemic inflammatory disease
- Having a disease that may cause polyneuropathy such as diabetes mellitus
- Having a pacemaker
- Having a disease affecting the central nervous system
- Having cervical radiculopathy
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
Short Form - 36 Quality of Life Questionnaire (SF-36)
Time frame: 15 minutes
SF-36 is a health-related quality of life questionnaire consisting of 8 scales (physical functioning, role limitations due to physical health problems, pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health). Responses to items are converted into scale scores from 0 (worst health) to 100 (best health).
Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)
Time frame: 10 minutes
Each question in the scale is scored between 1 and 5. The results range from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms).
Michigan Hand Questionnaire (MHQ)
Time frame: 15 minutes
The Michigan Hand Questionnaire (MHQ) is a hand-specific questionnaire that measures the health status of patients with acute and chronic hand disorders. The MHQ is an outcome tool consisting of 37 questions and 6 domains: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with function. Each domain is scored using an unweighted method by summing the responses on each scale (1 to 5) and normalising the scores to a scale from 0 to 100. A lower score indicates more severe disability, other than pain. The final score is obtained by averaging the six scores after inverting the pain score.
Boston Carpal Tunnel Questionnaire - Functional Status Scale
Time frame: 5 minutes
It is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.
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 27 Mar 2026.
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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?
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 6 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 27 Mar 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?
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?
Short Form - 36 Quality of Life Questionnaire (SF-36) (time frame: 15 minutes). The study lists 4 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 27 Mar 2026.