Hematological Markers in Idiopathic Carpal Tunnel Syndrome

NCT06952647 | Completed

• 1 other identifier: AnkaraTRH-FTR-NK-04
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal Tunnel Syndrome (CTS) cases are still classified as idiopathic. The rationale of this research is to investigate the role of chronic inflammation and vitamin B12 deficiency in the onset and severity of idiopathic CTS. This case-control study aims to evaluate inflammatory hematological markers and vitamin B12 levels in patients with idiopathic CTS compared to healthy controls, and to analyze their correlation with clinical and electrophysiological severity of the disease

Conditions

Carpal Tunnel Syndrome (CTS); Biomarkers / Blood

Keywords

Carpal Tunnel Syndrome (CTS); Biomarkers / blood; CALLY index; TG/HDL

Outcome Measures

Primary Outcomes (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.

  up to 4 weeks

Secondary Outcomes (7)

• Comparison of vitamin TG/HDL

  up to 4 weeks

• Evaluation of Electromyography severity

  up to 4 weeks

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

  up to 4 weeks

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

  up to 4 weeks

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

  up to 4 weeks

Study Arms (2)

Case-Idiopathic Carpal Tunnel Syndrome Patient Group

Patients diagnosed with idiopathic Carpal Tunnel Syndrome, confirmed by electrodiagnostic testing, with no identifiable secondary causes. Evaluated for inflammatory hematological markers, TG/HDL, and CALLY index.

Control- Healthy Control Group (Electrodiagnostically Screened)

Age- and sex-matched asymptomatic individuals without Carpal Tunnel Syndrome, confirmed through electrodiagnostic testing. Used as controls for comparison of inflammatory markers, TG/HDL, and CALLY index.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Age below 18 or above 65 years
• Pregnancy
• History of wrist trauma or surgical operation
• Diabetes mellitus
• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

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

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 41462402 BACKGROUND

• 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.

  PMID: 34466192 BACKGROUND

• 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.

  PMID: 29465486 BACKGROUND

• 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.

  PMID: 39639229 BACKGROUND

• 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.

  PMID: 34859834 BACKGROUND

• 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.

  PMID: 38606315 BACKGROUND

• 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.

  PMID: 31875987 BACKGROUND

• 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.

  PMID: 36860868 BACKGROUND

• 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.

  PMID: 36217059 BACKGROUND

• 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.

  PMID: 36525982 BACKGROUND

• 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.

  PMID: 12169318 BACKGROUND

• 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.

  PMID: 35735622 BACKGROUND

• 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.

  PMID: 36000134 BACKGROUND

• 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.

  PMID: 26612240 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Nadide Koca, M.D.

  University of Health Sciences, Ankara Training and Research Hospital, TURKEY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 1, 2025
• Study Start: April 1, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 20, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)