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Carpal Tunnel Syndrome (CTS)NCT06952647

Hematological and Metabolic Markers in Carpal Tunnel Syndrome

An observational study of Carpal Tunnel Syndrome (CTS) and Biomarkers / Blood, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, but the severity of symptoms experienced by patients does not always correspond to abnormalities detected by nerve conduction studies. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
How many people
197 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Apr 2025to 1 Jun 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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients referred to the Electromyography (EMG) laboratory/clinic with suspected Carpal Tunnel Syndrome (CTS) who underwent electrodiagnostic testing

Who may be able to join

  • Age between 18-65 years
  • Having undergone Electromyography (EMG) testing for Carpal Tunnel Syndrome (CTS)-like symptoms
  • Recent complete blood count, C-Reactive Protein (CRP), and albumin available

Who cannot join

  • Age below 18 or above 65 years
  • Pregnancy
  • History of wrist trauma or surgical operation
  • Chronic kidney disease
  • Gout
  • Rheumatoid arthritis
Show all 15Show fewer
  • Connective tissue disease
  • Thyroid disorders
  • Acromegaly
  • Polyneuropathy
  • Thoracic outlet syndrome
  • Brachial plexopathy
  • Cervical disc herniation
  • Presence of cardiac pacemaker
  • Steroid use

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

    Ankara, Altindag, 06230

Other trials in Turkey (Türkiye)

About this study

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, but the severity of symptoms experienced by patients does not always correspond to abnormalities detected by nerve conduction studies. This prospective cross-sectional study investigates whether routinely available metabolic, hematological, and inflammatory markers are associated with CTS and with patient-reported symptom and functional burden.

Adults referred for evaluation of suspected CTS were enrolled. Participants with electrodiagnostically confirmed CTS were compared with symptomatic individuals whose nerve conduction studies were normal. Clinical findings, Boston Carpal Tunnel Questionnaire scores, electrophysiological severity, and blood-based metabolic and inflammatory measures were evaluated. The study aims to better understand whether systemic metabolic and inflammatory factors contribute to the clinical expression of CTS beyond the degree of large-fiber nerve conduction abnormality.

Read the detailed description

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and results from compression of the median nerve at the wrist. Although local mechanical compression is central to the disorder, the clinical presentation of CTS varies considerably. Patients with similar nerve conduction abnormalities may report very different levels of pain, paresthesia, weakness, and functional limitation. This variability suggests that systemic metabolic and inflammatory factors may contribute to the clinical expression of CTS in addition to the degree of median nerve conduction abnormality.

Several systemic conditions, including obesity, diabetes mellitus, thyroid disease, and inflammatory disorders, are associated with CTS. Obesity and metabolic dysfunction may increase peripheral nerve vulnerability through metabolic, vascular, and inflammatory mechanisms. Low-grade systemic inflammation has also been investigated as a possible contributor to CTS. Routinely available blood measurements may therefore provide additional information about systemic factors accompanying the disorder.

In recent years, several hematological indices derived from routine blood counts have been used as markers of systemic inflammatory activity. These include the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index (SII), and systemic inflammation response index (SIRI). Metabolic and inflammation-related measures such as triglycerides, the triglyceride-to-high-density lipoprotein cholesterol ratio (TG/HDL), the C-reactive protein-to-albumin ratio (CAR), and the C-reactive protein-albumin-lymphocyte (CALLY) index may also reflect different aspects of systemic metabolic and inflammatory burden.

This prospective cross-sectional study includes adults referred for electrodiagnostic evaluation because of symptoms suggestive of CTS. Participants with electrodiagnostically confirmed median neuropathy at the wrist constitute the CTS group, while symptomatic individuals with normal nerve conduction studies serve as the comparison group. This design allows systemic markers associated with confirmed median nerve involvement to be examined against a clinically relevant symptomatic reference group rather than against asymptomatic healthy volunteers.

Clinical examination and nerve conduction studies are performed according to the study protocol. In participants with confirmed CTS, symptom severity and functional status are assessed using the Boston Carpal Tunnel Questionnaire (BCTQ). Routine hematological, biochemical, metabolic, and inflammatory measurements are obtained from fasting blood samples, and derived inflammatory and metabolic indices are calculated from their component variables.

The study evaluates three related but distinct clinical domains: the presence of electrodiagnostically confirmed CTS, patient-reported symptom and functional burden, and electrodiagnostic severity. The main objective is to determine whether routinely available metabolic and inflammatory measures are associated differently with these domains. In particular, the study examines whether systemic metabolic or inflammatory factors may help explain differences in patient-reported burden that are not fully captured by conventional nerve conduction findings.

Keywords
Carpal Tunnel Syndrome (CTS), Biomarkers / blood, CALLY index, TG/HDL, Triglycerides
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 groups in NCT06952647
Study groupRoleWhat they receive
Electrodiagnostically Confirmed CTS GroupAdults with symptoms suggestive of carpal tunnel syndrome and electrodiagnostic evidence of median neuropathy at the wrist. Participants were evaluated for clinical findings, patient-reported symptom and functional burden, electrodiagnostic severity, and fasting metabolic, hematological, and inflammatory measures.
Symptomatic Electrodiagnostically Normal Control GroupAdults referred with symptoms suggestive of carpal tunnel syndrome but with normal nerve conduction studies. Participants were evaluated using the same clinical and fasting metabolic, hematological, and inflammatory measures as the CTS group and served as the symptomatic comparison group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Systemic Inflammation Response Index (SIRI) as an Inflammatory Marker

    The systemic inflammation response index (SIRI) is calculated as neutrophil count × monocyte count / lymphocyte count. It reflects the combined effect of neutrophil and monocyte-driven innate immunity versus lymphocyte-mediated adaptive immunity. SIRI has been proposed as a robust marker of inflammation in several chronic diseases.

    In the current study, SIRI was evaluated in individuals with and without Carpal Tunnel Syndrome (CTS) to investigate its potential as an indicator of inflammatory burden.

    Measured: up to 4 weeks

Secondary outcomes (7)
  1. Comparison of TG/HDL

    Comparison of TG/HDL between case and control groups

    Measured: up to 4 weeks

  2. Evaluation of Electrodiagnostic Severity of Carpal Tunnel Syndrome

    Electromyography (EMG) is part of electrodiagnostic assessment used to evaluate peripheral nerve and muscle function. In this study, carpal tunnel syndrome severity was classified based on nerve conduction study findings as follows:

    • Mild: Median-ulnar sensory distal latency difference >1.0 ms or median-ulnar fourth-digit peak sensory latency difference >0.5 ms.
    • Moderate: Median motor distal latency >4.0 ms.
    • Severe: Markedly reduced or absent median sensory nerve action potential, median motor amplitude <5.0 mV, or median motor distal latency >5.5 ms.

    Measured: up to 4 weeks

  3. - Comparison of C-Reactive Protein levels (CRP) and CALLY

    • Comparison of C-Reactive Protein levels (CRP) levels between case and control groups. CRP is an acute phase protein used as an inflammatory marker. CRP's half-life is approximately 19 hours, making it a responsive marker that can indicate both the onset of inflammation and the response to treatment relatively quickly. CALLY (C-reactive protein-Albumin-Lymphocyte) index is a composite scoring system that integrates CRP, albumin, and lymphocyte count to reflect both inflammatory status and nutritional-immune condition simultaneously.

    Measured: up to 4 weeks

  4. Evaluation of Platelet/Lymphocyte Ratio (PLR) as an Inflammatory Marker

    Platelet/lymphocyte ratio (PLR) is another hematological marker that reflects systemic inflammation. During inflammatory responses, platelet counts often increase while lymphocyte counts decrease, resulting in an elevated PLR. Platelets play an active role in inflammation by releasing inflammatory mediators and interacting with leukocytes. PLR, calculated from routine blood tests, has been increasingly used in the assessment of inflammatory conditions.

    In this study, PLR values were compared between patients with Carpal Tunnel Syndrome (CTS) and healthy controls to evaluate its association with inflammation in CTS.

    Measured: up to 4 weeks

  5. Evaluation of Monocyte/Lymphocyte Ratio (MLR) as an Inflammatory Marker

    Monocyte/lymphocyte ratio (MLR) is a peripheral blood marker used to assess systemic inflammatory status. Monocytes contribute to chronic inflammation and tissue remodeling, while lymphocytes are typically reduced in inflammatory states. An increased MLR may reflect an enhanced inflammatory response. Like other ratios, MLR can be easily derived from complete blood count parameters.

    In this study, MLR was analyzed in patients with and without Carpal Tunnel Syndrome (CTS) to explore its relevance as a potential inflammatory biomarker.

    Measured: up to 4 weeks

  6. Evaluation of Neutrophil/Lymphocyte Ratio (NLR) as an Inflammatory Marker

    In inflammatory diseases, the immune response often leads to an increase in circulating neutrophils and a decrease in lymphocytes, resulting in an elevated neutrophil/lymphocyte ratio (NLR). This parameter has recently gained attention as a simple, cost-effective, and readily available marker of systemic inflammation. NLR is derived from routine complete blood count tests and reflects the balance between innate (neutrophils) and adaptive (lymphocytes) immune responses.

    In the present study, NLR was compared between patients with Carpal Tunnel Syndrome (CTS) and healthy controls to investigate its potential role as a marker of inflammation in CTS.

    Measured: up to 4 weeks

  7. Evaluation of Systemic Immune-inflammation Index (SII) as an Inflammatory Marker

    The systemic immune-inflammation index (SII) is a composite marker calculated using the formula: platelet count × neutrophil count / lymphocyte count. It simultaneously incorporates three types of immune cells and is considered a more comprehensive indicator of the systemic inflammatory status. Elevated SII levels have been associated with various inflammatory and immune-mediated conditions.

    In this study, SII values were compared between CTS patients and healthy controls to assess its potential utility in identifying inflammatory activity in CTS.

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start20 Apr 2025
  3. Primary completion1 Apr 2026
  4. Study completion1 Jun 2026

Resources

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
Case-control
Time perspective
Prospective
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06952647
Sponsor's protocol ID
AnkaraTRH-FTR-NK-04
Status last verified
Aug 2026
First submitted
19 Apr 2025
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to institutional policies regarding patient privacy and data protection regulations

Publications

  • Che X, Chen Q, He D, Fan L. Correlation of CRP/Albumin ratio and low serum albumin with the risk of major adverse cardiovascular events in elderly patients with chronic total occlusion. Hereditas. 2025 Dec 29;163(1):19. doi: 10.1186/s41065-025-00622-1.

    PubMed 41462402
  • Razavi AS, Karimi N, Bashiri F. The relationship of serum lipid profiles and obesity with the severity of carpal tunnel syndrome. Pan Afr Med J. 2021 Jun 1;39:90. doi: 10.11604/pamj.2021.39.90.27234. eCollection 2021.

    PubMed 34466192
  • Yano K, Kawabata A, Ikeda M, Suzuki K, Kaneshiro Y, Egi T. Hypercholesterolemia Is Associated with the Subjective Evaluation of Postoperative Outcomes in Patients with Idiopathic Carpal Tunnel Syndrome Who Undergo Surgery: A Multivariate Analysis. Plast Reconstr Surg. 2018 Apr;141(4):941-948. doi: 10.1097/PRS.0000000000004228.

    PubMed 29465486
  • Zhu D, Lin YD, Yao YZ, Qi XJ, Qian K, Lin LZ. Negative association of C-reactive protein-albumin-lymphocyte index (CALLY index) with all-cause and cause-specific mortality in patients with cancer: results from NHANES 1999-2018. BMC Cancer. 2024 Dec 5;24(1):1499. doi: 10.1186/s12885-024-13261-y.

    PubMed 39639229
  • Tonga F, Bahadir S. The Factors Associated with Carpal Tunnel Syndrome Severity. Turk Neurosurg. 2022;32(3):392-397. doi: 10.5137/1019-5149.JTN.34519-21.2.

    PubMed 34859834
  • Zvonickova K, Rhee A, Sandy-Hindmarch O, Furniss D, Wiberg A, Schmid AB. Systemic low-grade C-reactive protein is associated with proximal symptom spread in carpal tunnel syndrome. Pain Rep. 2024 Apr 10;9(3):e1156. doi: 10.1097/PR9.0000000000001156. eCollection 2024 Jun.

    PubMed 38606315
  • Gunes M, Buyukgol H. Correlation of neutrophil/lymphocyte and platelet/lymphocyte ratios with the severity of idiopathic carpal tunnel syndrome. Muscle Nerve. 2020 Mar;61(3):369-374. doi: 10.1002/mus.26791. Epub 2020 Jan 9.

    PubMed 31875987
  • Wang RH, Wen WX, Jiang ZP, Du ZP, Ma ZH, Lu AL, Li HP, Yuan F, Wu SB, Guo JW, Cai YF, Huang Y, Wang LX, Lu HJ. The clinical value of neutrophil-to-lymphocyte ratio (NLR), systemic immune-inflammation index (SII), platelet-to-lymphocyte ratio (PLR) and systemic inflammation response index (SIRI) for predicting the occurrence and severity of pneumonia in patients with intracerebral hemorrhage. Front Immunol. 2023 Feb 13;14:1115031. doi: 10.3389/fimmu.2023.1115031. eCollection 2023.

    PubMed 36860868
  • Malakootian M, Soveizi M, Gholipour A, Oveisee M. Pathophysiology, Diagnosis, Treatment, and Genetics of Carpal Tunnel Syndrome: A Review. Cell Mol Neurobiol. 2023 Jul;43(5):1817-1831. doi: 10.1007/s10571-022-01297-2. Epub 2022 Oct 10.

    PubMed 36217059
  • Padua L, Cuccagna C, Giovannini S, Coraci D, Pelosi L, Loreti C, Bernabei R, Hobson-Webb LD. Carpal tunnel syndrome: updated evidence and new questions. Lancet Neurol. 2023 Mar;22(3):255-267. doi: 10.1016/S1474-4422(22)00432-X. Epub 2022 Dec 13.

    PubMed 36525982
  • Werner RA, Andary M. Carpal tunnel syndrome: pathophysiology and clinical neurophysiology. Clin Neurophysiol. 2002 Sep;113(9):1373-81. doi: 10.1016/s1388-2457(02)00169-4.

    PubMed 12169318
  • Otelea MR, Nartea R, Popescu FG, Covaleov A, Mitoiu BI, Nica AS. The Pathological Links between Adiposity and the Carpal Tunnel Syndrome. Curr Issues Mol Biol. 2022 Jun 8;44(6):2646-2663. doi: 10.3390/cimb44060181.

    PubMed 35735622
  • Joshi A, Patel K, Mohamed A, Oak S, Zhang MH, Hsiung H, Zhang A, Patel UK. Carpal Tunnel Syndrome: Pathophysiology and Comprehensive Guidelines for Clinical Evaluation and Treatment. Cureus. 2022 Jul 20;14(7):e27053. doi: 10.7759/cureus.27053. eCollection 2022 Jul.

    PubMed 36000134
  • Newington L, Harris EC, Walker-Bone K. Carpal tunnel syndrome and work. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):440-53. doi: 10.1016/j.berh.2015.04.026. Epub 2015 May 27.

    PubMed 26612240

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS) and Biomarkers / Blood, run by Ankara Training and Research Hospital 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 15 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 Aug 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?

Evaluation of Systemic Inflammation Response Index (SIRI) as an Inflammatory Marker (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06952647, which also lists 14 linked publications.

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 Aug 2026.

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