Carpal Tunnel SyndromeNCT06635200
Pain Phenotype in Patients With 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 this study was to determine the dominant pain phenotype in a group of patients with Carpal Tunnel Syndrome by applying the International Association for the Study of Pain (IASP) criteria. 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
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2024to 20 Mar 2025
- 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
- Adult, Older adult
Study population: Voluntary participants between the ages of 18-65 who have been diagnosed with Carpal Tunnel Syndrome will be included in the study
Who may be able to join
- Being diagnosed with CTS
- 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
- Hypersensitivity to heat and cold
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Dominant Pain Phenotype in Patients With Carpal Tunnel Syndrome
The aim of this study was to determine the dominant pain phenotype in a group of patients with Carpal Tunnel Syndrome by applying the International Association for the Study of Pain (IASP) criteria.
Read the detailed description
Voluntary participants between the ages of 18-65 who have been diagnosed with CTS will be included in the study.The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain and Carpal Tunnel Syndrome will be applied to people with CTS. Thermal pain threshold, mechanical pain sensitivity and static/dynamic allodynia will be evaluated to determine pain hypersensitivity (Step 5). Specific questions will be asked to confirm the history of hypersensitivity in patients (Step 6). Finally, comorbidities, if any, will be determined (Step 7). As a result, the pain phenotype of patients with CTS will be determined (Nociceptive, Neuropathic or Nosiplastic). Shapiro-Wilk test will be performed to determine the distribution of the data. One-way ANOVA (continuous) or Kruskal-Wallis (categorical) will be used to examine whether the dependent variables differ between groups. 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 |
|---|---|---|
| Patients with carpal tunnel syndrome with a nociceptive pain phenotype | Not described | |
| Patients with carpal tunnel syndrome with a neuropathic pain phenotype | Not described | |
| Patients with carpal tunnel syndrome with a nosiplastic pain phenotype | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
Measured: 1 minute
Secondary outcomes (5)
Cold Pain Threshold
For cold pain threshold, ice cubes (-5°C) placed in a plastic bag will be placed on the patients' skin for 10 seconds. Increased sensory perception will be considered as gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: 2 minutes
Hot Pain Threshold
Thermal pain perception will be tested using a 3 cm2 sized metal piece equal to (lab-QST thermode size). The metal parts will be heated to 45˚C for hot pain threshold. The metal pieces will be applied to the skin for 3 seconds. It will be determined whether the stimulus is painful (yes/no), and if painful, the intensity of the pain on a numerical rating scale (NRS) (0: no pain, 10: imaginably worse pain).
Measured: 2 minutes
Mechanical Pain Threshold
Mechanical pain threshold: to be assessed with a toothpick and a von Frey filament (256 mN). Increased sensory perception will be considered to reflect gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).
Measured: 3 minutes
Static mechanical allodynia
A digital algometer will be used to measure Pressure Pain Threshold levels. Pressure will be applied at a rate of approximately 30 kPa with the algometer placed perpendicular to the point of application. Participants will be instructed to report when the sensation changes from pressure to pain. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).
Measured: 3 minutes
Dynamic Mechanical Allodynia
Patients will be touched on the affected area and the control area with a brush, an ear stick and a piece of cotton wool. The assessment tools will be applied 4 times by drawing a cross of 2 strokes (length 5 cm) at an angle of 90˚C in each direction. For each stimulus (brush/ear swab/cotton swab), they will indicate (1) whether the stimulus was perceived as painful (yes/no) and (2) the pain intensity on the NRS-11 (0 no pain, 10 imaginably worse pain).
Measured: 3 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 start5 Nov 2024
- Primary completion18 Mar 2025
- Study completion20 Mar 2025
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
- 113 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 Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635200
- Sponsor's protocol ID
- 2024
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2024
- Last updated
- 25 Mar 2025
- 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Dominant Pain Phenotype in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06635200
- Acronym / sponsor ID
- 2024
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (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 this study was to determine the dominant pain phenotype in a group of patients with Carpal Tunnel Syndrome by applying the International Association for the Study of Pain (IASP) criteria.
Detailed description
Voluntary participants between the ages of 18-65 who have been diagnosed with CTS will be included in the study.The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain and Carpal Tunnel Syndrome will be applied to people with CTS. Thermal pain threshold, mechanical pain sensitivity and static/dynamic allodynia will be evaluated to determine pain hypersensitivity (Step 5). Specific questions will be asked to confirm the history of hypersensitivity in patients (Step 6). Finally, comorbidities, if any, will be determined (Step 7). As a result, the pain phenotype of patients with CTS will be determined (Nociceptive, Neuropathic or Nosiplastic). Shapiro-Wilk test will be performed to determine the distribution of the data. One-way ANOVA (continuous) or Kruskal-Wallis (categorical) will be used to examine whether the dependent variables differ between groups. 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 |
|---|---|---|
| Patients with carpal tunnel syndrome with a nociceptive pain phenotype | – | – |
| Patients with carpal tunnel syndrome with a neuropathic pain phenotype | – | – |
| Patients with carpal tunnel syndrome with a nosiplastic pain phenotype | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Voluntary participants between the ages of 18-65 who have been diagnosed with Carpal Tunnel Syndrome will be included in the study
Key inclusion criteria (3 listed)
- Being diagnosed with CTS
- Being between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (7 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
Numerical Rating Scale
Time frame: 1 minute
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
5 secondary outcomes
Cold Pain Threshold
Time frame: 2 minutes
Hot Pain Threshold
Time frame: 2 minutes
Mechanical Pain Threshold
Time frame: 3 minutes
Static mechanical allodynia
Time frame: 3 minutes
Dynamic Mechanical Allodynia
Time frame: 3 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 25 Mar 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 Science 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 7 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 25 Mar 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?
Numerical Rating Scale (time frame: 1 minute). 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 25 Mar 2025.