Gabapentin and Pregabalin Effects on Inflammation and Cardiac Function in Peripheral Neuropathic Pain

NCT07755514 | Not Yet Recruiting

• 1 other identifier: PREGABA-2026
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral Neuropathic Pain

Keywords

gabapentin; pregabalin; Inflammatory Biomarkers; Subclinical Cardiac Dysfunction; Echocardiography; Neuropathic Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and 30 ± 7 days after treatment initiation

• 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.

  Baseline and 30 ± 7 days after treatment initiation

• 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.

  Baseline and 30 ± 7 days after treatment initiation

• 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.

  Baseline and 30 ± 7 days after treatment initiation

Secondary Outcomes (3)

• Change From Baseline in Neuropathic Pain Intensity

  Baseline and 30 ± 7 days after treatment initiation

• Change From Baseline in Left Ventricular Ejection Fraction

  Baseline and 30 ± 7 days after baseline

• Change From Baseline in Left Atrial Volume Index

  Baseline and 30 ± 7 days after baseline

Study Arms (3)

Gabapentin Cohort

Adults with peripheral neuropathic pain who are prescribed gabapentin by the treating physician as part of routine clinical care, independently of study participation. Baseline assessments will be completed before the first dose, and follow-up assessments will be performed 30 ± 7 days later. The investigators will not assign the medication, determine the dose, or modify treatment decisions.

Drug: Gabapentin

Pregabalin Cohort

Adults with peripheral neuropathic pain who are prescribed pregabalin by the treating physician as part of routine clinical care, independently of study participation. Baseline assessments will be completed before the first dose, and follow-up assessments will be performed 30 ± 7 days later. The investigators will not assign the medication, determine the dose, or modify treatment decisions.

Drug: Pregabalin

Healthy Control Cohort

Adults without peripheral neuropathy or chronic neuropathic pain and without current gabapentin or pregabalin use. Healthy controls will be frequency matched to the patient cohorts, as feasible, by age, sex, and body mass index. Assessments will be performed at enrollment and again after 30 ± 7 days. Participants in this cohort will not receive gabapentin or pregabalin as part of the study.

Interventions

Gabapentin DRUG

Gabapentin 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.

Gabapentin Cohort

Pregabalin DRUG

Pregabalin 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 Cohort

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Related Publications (3)

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.

  PMID: 25559473 RESULT

• Fiore NT, Debs SR, Hayes JP, Duffy SS, Moalem-Taylor G. Pain-resolving immune mechanisms in neuropathic pain. Nat Rev Neurol. 2023 Apr;19(4):199-220. doi: 10.1038/s41582-023-00777-3. Epub 2023 Mar 1.

  PMID: 36859719 RESULT

• Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.

  PMID: 25575710 RESULT

MeSH Terms

Conditions

Neuralgia

Interventions

Gabapentin; Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Tamer Tamdogan, MD

CONTACT

0905065449917; tamer.tamdogan@giresun.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.MD

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share