This prospective, controlled, observational cohort study will evaluate short-term changes in inflammatory biomarkers and subclinical cardiac function in adults with peripheral neuropathic pain who are prescribed gabapentin or pregabalin as part of routine clinical care. A total of 75 participants will be enrolled: 25 patients starting gabapentin, 25 patients starting pregabalin, and 25 healthy controls without peripheral neuropathy or chronic neuropathic pain. Treatment selection and dose adjustments will be determined by the treating physician and will not be assigned by the study investigators. Participants will be assessed at baseline and again after 30 ± 7 days. Assessments will include clinical information, pain severity, routine laboratory results, inflammatory biomarkers, and standard transthoracic echocardiography. No additional blood will be collected solely for research; leftover serum from routine testing will be used. The primary aim is to compare changes over time between the gabapentin and pregabalin groups, while the healthy control group will provide a reference for interpretation.
Patient Cohorts:Age 18 years or older.A clinical diagnosis of peripheral neuropathic pain based on medical history, physical and neurological examination, and, when available, electrophysiological testing or imaging.A determination, following routine clinical evaluation, that initiation of gabapentin or pregabalin is clinically appropriate.Ability to complete baseline assessments before the first dose.Ability and willingness to provide written informed consent.Healthy Controls:Age 18 years or older.Attendance at the cardiology department for a routine health examination or check-up.No peripheral neuropathy, chronic neuropathic pain, gabapentin or pregabalin use, or clinically significant cardiovascular disease based on standard clinical screening.Eligibility, as far as possible, for frequency matching with the patient cohorts by age, sex, and body mass index.Ability and willingness to provide written informed consent.
Known or newly identified heart failure.2. Clinically significant valvular heart disease, cardiomyopathy, significant cardiac arrhythmia, previous acute coronary syndrome, or other significant structural heart disease.3. Active or recent acute infection.4. Active autoimmune or systemic inflammatory disease.5. Active malignancy.6. Recent major surgery, severe trauma, or acute cardiovascular event.7. Current systemic corticosteroid or immunosuppressive treatment.8. Advanced renal or hepatic dysfunction.9. Uncontrolled thyroid disease.10. Pregnancy or breastfeeding.11. Any acute clinical condition likely to substantially affect baseline biomarker measurements.12. Current use of gabapentin or pregabalin at baseline.13. Inability to complete baseline measurements before the first dose of gabapentin or pregabalin.14. Any other condition that, in the investigator's judgment, would prevent safe or appropriate participation in the study
The study population will consist of 75 adults recruited at a single center. The patient population will include adults with clinically diagnosed peripheral neuropathic pain who are prescribed gabapentin or pregabalin as part of routine clinical care. Eligible patients will be enrolled consecutively into the gabapentin cohort (n=25) or pregabalin cohort (n=25), according to the treatment selected by the treating physician independently of the study.The healthy control cohort will include 25 adults attending the cardiology outpatient clinic for a routine health examination or check-up who have no peripheral neuropathy, chronic neuropathic pain, current gabapentin or pregabalin use, or clinically significant cardiovascular disease. Healthy controls will be frequency matched to the patient cohorts, as feasible, by age, sex, and body mass index.
Cohort
Prospective
Gabapentin
DrugGabapentin prescribed as part of routine clinical care for peripheral neuropathic pain. The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation. The study investigators will not assign or modify treatment.
Pregabalin
DrugPregabalin prescribed as part of routine clinical care for peripheral neuropathic pain. The decision to initiate treatment, as well as the starting dose, dose adjustments, continuation, or discontinuation, will be determined by the treating physician independently of study participation. The study investigators will not assign or modify treatment.
Change From Baseline in Serum NLRP3 Concentration
Serum NLRP3 concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing. Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit. Change will be calculated as the follow-up value minus the baseline value. The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
Change From Baseline in Serum NF-κB p65 Concentration
Serum nuclear factor kappa B p65 (NF-κB p65) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing. Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit. Change will be calculated as the follow-up value minus the baseline value. The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
Change From Baseline in Serum STAT3 Concentration
Serum signal transducer and activator of transcription 3 (STAT3) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA) in coded leftover serum obtained after completion of routine clinical laboratory testing. Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit. Change will be calculated as the follow-up value minus the baseline value. The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
Change From Baseline in Left Ventricular Global Longitudinal Strain
Left ventricular global longitudinal strain (LV-GLS) will be assessed by standard transthoracic echocardiography and reported as a percentage. Measurements will be performed before the first dose of gabapentin or pregabalin and at the follow-up visit, using the same echocardiography system and analysis software whenever possible. Change will be calculated as the follow-up value minus the baseline value. The primary comparison will evaluate the group-by-time interaction between the gabapentin and pregabalin cohorts.
Change From Baseline in Neuropathic Pain Intensity
Neuropathic pain intensity will be assessed in the gabapentin and pregabalin cohorts using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst imaginable pain). Change will be calculated as the follow-up score minus the baseline score
Change From Baseline in Left Ventricular Ejection Fraction
Left ventricular ejection fraction will be measured by standard transthoracic echocardiography using the biplane Simpson method and reported as a percentage. Change will be calculated as the follow-up value minus the baseline value.
Change From Baseline in Left Atrial Volume Index
Tricuspid annular plane systolic excursion (TAPSE) will be measured by transthoracic echocardiography and reported in millimeters as an indicator of right ventricular systolic function. Change will be calculated as the follow-up value minus the baseline value.
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