An observational study in Peripheral Neuropathic Pain, sponsored by Giresun University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Giresun University · Observational
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.
Peripheral neuropathic pain is a chronic condition associated with a lesion or disease of the somatosensory nervous system. Neuroimmune and inflammatory mechanisms may contribute to its development and persistence. Gabapentin and pregabalin are alpha-2-delta ligands commonly prescribed for neuropathic pain; however, whether these medications are associated with different short-term changes in inflammatory pathways and early cardiac function remains unclear.This is a single-center, prospective, controlled, observational cohort study with repeated measurements. A total of 75 adults will be enrolled in three groups: 25 patients with peripheral neuropathic pain who are prescribed gabapentin, 25 patients with peripheral neuropathic pain who are prescribed pregabalin, and 25 healthy controls without peripheral neuropathy or chronic neuropathic pain.The decision to initiate gabapentin or pregabalin, including the selected drug, starting dose, dose adjustment, continuation, or discontinuation, will be made by the treating neurosurgery physician as part of routine clinical care and independently of study participation. The investigators will not randomize participants, assign treatment, determine medication doses, or modify routine treatment decisions.Patients in the gabapentin and pregabalin cohorts will undergo baseline assessment before the first medication dose and a follow-up assessment 30 ± 7 days later. Healthy controls will undergo corresponding assessments at enrollment and after 30 ± 7 days. Clinical assessments will include demographic characteristics, neuropathic pain characteristics, pain severity measured using a 0-10 numerical rating scale, comorbidities, concomitant medications, blood pressure, heart rate, medication exposure, adherence, treatment tolerability, and adverse events.Routine laboratory findings will be recorded. No additional blood sample will be collected solely for research purposes. After completion of clinically required laboratory testing, leftover serum will be coded, aliquoted, stored at -80 °C, and used to measure the inflammatory and signaling biomarkers NLRP3, nuclear factor kappa B p65 (NF-κB p65), and signal transducer and activator of transcription 3 (STAT3), according to the manufacturers' instructions.Standard transthoracic echocardiography will be performed by a cardiologist at baseline and follow-up. Echocardiographic assessments will include left ventricular ejection fraction, left ventricular global longitudinal strain, left ventricular dimensions and wall thickness, left atrial volume index, transmitral E/A ratio, tissue Doppler e' velocity, E/e' ratio, tricuspid annular plane systolic excursion, right ventricular S' velocity, and other clinically relevant standard measurements.The primary objective is to compare changes from baseline to 30 ± 7 days in inflammatory biomarkers and subclinical cardiac function between the gabapentin and pregabalin cohorts. The primary analysis will assess the group-by-time interaction using a linear mixed-effects model. The healthy control cohort will serve as a reference group for secondary and exploratory comparisons. Additional analyses will examine associations among biomarker changes, pain severity, cardiac function, clinical characteristics, medication exposure, and treatment tolerability.De-identified clinical findings may also be integrated with publicly available, anonymous transcriptomic or genomic summary datasets for exploratory, hypothesis-generating translational analyses. No genomic sequencing will be performed on study participants, and biological samples will not be transferred outside the study institution.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's planned enrollment of 75 is below the median of 102 across 231 observational studies indexed under Neuralgia.
Browse Neuralgia studies →Giresun University is the lead sponsor of 57 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 30 ± 7 days after treatment initiation
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
Time frame: Baseline and 30 ± 7 days after treatment initiation
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.
Time frame: Baseline and 30 ± 7 days after baseline
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.
Time frame: Baseline and 30 ± 7 days after baseline
No study locations are listed for this record.
Plan to share: No — There is currently no plan to make individual participant-level data publicly available. Study findings will be reported in aggregate and de-identified form. Any sharing of de-identified data with authorized researchers will be subject to ethics committee approval, institutional policies, and applicable data protection requirements.
Start is estimated for Aug 2026; primary completion for Sep 2026, 1 month later.
Of 77 non-industry observational studies under Neuralgia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 1 month is below that.
Counting every sponsor, half of 87 studies reached it within 18 months; a quarter within 12 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Giresun University