New turkish diagnostic tool for carpal tunnel syndrome under study
NCT ID NCT07420049
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study aims to translate and test a diagnostic tool called CTS-6 for Turkish-speaking patients with carpal tunnel syndrome. Researchers will enroll 126 adults, including healthy volunteers, people with symptoms, and those already diagnosed. The goal is to ensure the tool is accurate and reliable for use in Turkish clinics.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CTS-6 Evaluation Tool (diagnostic questionnaire)
- What this could lead to
- If successful, this could provide a reliable Turkish-language tool to help doctors diagnose carpal tunnel syndrome more accurately.
- What could go wrong
- This is a small, early-stage validation study, not a treatment trial. The tool may not perform as well in real-world settings or across different clinics.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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126 people
The number who actually took part.
- Started
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Mar 2026
- Finished
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Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
C) STUDY POPULATİON AND PARTİCİPANT GROUPS: This cross-sectional study will include participants aged 18-60 years who present to the Physical Medicine and Rehabilitation Outpatient Clinics at Istanbul University, Istanbul Faculty of Medicine, Esnaf Hospital, between March 1, 2026 and July 1, 2026. Three separate groups will be formed from participants who do not meet the predefined exclusion criteria: (1) a control group of healthy individuals with no clinical or electrophysiological pathology, (2) a group presenting with CTS-like symptoms but considered normal based on electrophysiological evaluation, and (3) a group diagnosed with CTS according to clinical and electrophysiological criteria. Accounting for potential dropouts, 42 participants per group will be recruited, for a total of 126 participants. All participants will receive detailed written and verbal information about the study's objectives, duration, and procedures, and written informed consent will be obtained.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
1\) INCLUSION CRITERIA: Participants aged 18-60 years will be categorized into three groups: 1. Healthy Control Group 2. Group Presenting with CTS-like Symptoms 3. Group Diagnosed with CTS Based on Defined Criteria a) Healthy Control Group: Participants in this group will have no clinical symptoms consistent with CTS based on specified clinical criteria and will be considered normal according to the defined electrophysiological criteria. b) Group Presenting with CTS-like Symptoms: Participants in this group may exhibit symptoms similar to clinically defined CTS; however, electrophysiological evaluations will show normal findings according to the defined criteria. b.1) Clinical Findings / Symptoms: b.1.1) Symptoms: (A) Sensory symptoms in any of the 1st, 2nd, 3rd, or the radial part of the 4th finger (B) Symptoms alleviated by shaking, squeezing, or other hand movements (C) Pain or paresthesia associated with gripping or hand use (D) Nocturnal paresthesia causing awakening from sleep b.1.2) Diagnostic Tests / Signs: 1. Tinel Sign 2. Phalen Test 3. Reverse Phalen Test 4. Carpal Tunnel Compression Test 5. Flick Sign A clinical diagnosis of CTS will require symptoms persisting for at least three months, with at least one of the B, C, or D symptoms in addition to symptom A, plus at least one positive diagnostic test or sign. b.2) Electrophysiological Evaluation: b.2.1) Mild CTS: Median-to-ulnar sensory distal latency difference ≥ 0.4 ms at the 4th finger Median nerve sensory distal latency ≥ 2.8 ms at the 2nd finger Median nerve conduction velocity \< 50 m/s Sensory nerve action potential ≥ 12 µV b.2.2) Moderate CTS: Median nerve distal motor latency at Abductor Pollicis Brevis (APB) 4 ms ≤ x \< 6.5 ms Median nerve conduction velocity \< 50 m/s Compound Muscle Action Potential (CMAP) ≥ 5 mV b.2.3) Severe CTS: Median nerve distal motor latency at APB ≥ 6.5 ms Median nerve conduction velocity \< 50 m/s and/or CMAP \< 5 mV c) Group Diagnosed with CTS Based on Defined Criteria: Participants in this group meet the clinical diagnostic criteria for CTS and additionally fulfill electrophysiological evaluation criteria for mild, moderate, or severe CTS. 2\) EXCLUSION CRITERIA: 2.a) Participants Diagnosed with CTS Based on Defined Criteria: History of cardiac pacemaker History of lymphedema in the affected extremity History of cervical radiculopathy Presence of ipsilateral upper extremity tenosynovitis Presence of another compressive neuropathy in the ipsilateral upper extremity History of peripheral polyneuropathy Presence of metabolic disease History of fracture in the hand, wrist, or forearm Current pregnancy Open wound on the wrist Uncontrolled medical conditions (including endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal, active systemic inflammatory disease, and/or malignancy) History of inflammatory rheumatologic or autoimmune disease Age \<18 years or \>60 years Trauma to the wrist or median nerve within the last 3 months Received any injection in the wrist Undergone any surgical procedure on the wrist Mental or cognitive incapacity preventing understanding or completion of questionnaires 2.b) Participants Presenting with CTS-like Symptoms: Mental or cognitive incapacity preventing understanding or completion of questionnaires Age \<18 years or \>60 years CTS diagnosis confirmed based on clinical and electrophysiological criteria 2.c) Healthy Control Group Participants: Mental or cognitive incapacity preventing understanding or completion of questionnaires Age \<18 years or \>60 years Presence of any clinical symptoms potentially related to CTS based on defined clinical criteria Electrophysiological findings consistent with CTS
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Istanbul Unıversity, Istanbul Medicine Faculty, Esnaf Hospital
Istanbul, Fatih, 34093, Turkey (Türkiye)
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Other studies related to the condition(s) this trial covers.
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