NCT06952647

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

April 19, 2025

Last Update Submit

August 24, 2026

Conditions

Keywords

Carpal Tunnel Syndrome (CTS)Biomarkers / bloodCALLY indexTG/HDLTriglycerides

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 TG/HDL

    up to 4 weeks

  • Evaluation of Electrodiagnostic Severity of Carpal Tunnel Syndrome

    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

  • +2 more secondary outcomes

Study Arms (2)

Electrodiagnostically Confirmed CTS Group

Adults 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 Group

Adults 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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 41462402BACKGROUND
  • 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: 34466192BACKGROUND
  • 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: 29465486BACKGROUND
  • 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: 39639229BACKGROUND
  • 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: 34859834BACKGROUND
  • 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: 38606315BACKGROUND
  • 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: 31875987BACKGROUND
  • 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: 36860868BACKGROUND
  • 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: 36217059BACKGROUND
  • 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: 36525982BACKGROUND
  • 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: 12169318BACKGROUND
  • 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: 35735622BACKGROUND
  • 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: 36000134BACKGROUND
  • 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: 26612240BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds 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 20, 2025

Primary Completion

April 1, 2026

Study Completion

June 1, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies regarding patient privacy and data protection regulations

Locations