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NCT Number: NCT06952647

Hematological and Metabolic Markers in Carpal Tunnel Syndrome

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: up to 4 weeks

    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.

Secondary outcomes

  1. Comparison of TG/HDL

    Time frame: up to 4 weeks

    Comparison of TG/HDL between case and control groups

  2. Evaluation of Electrodiagnostic Severity of Carpal Tunnel Syndrome

    Time frame: up to 4 weeks

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

    Time frame: up to 4 weeks

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

    Time frame: up to 4 weeks

    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.

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

    Time frame: up to 4 weeks

    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.

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

    Time frame: up to 4 weeks

    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.

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

    Time frame: up to 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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