Predictors of Success After Intercostal Nerve Radiofrequency Treatment for Intercostal Neuralgia (ICN-RF-IN)

January 16, 2026 updated by: Mesut Bakır, Mersin University

Predictors of Treatment Success After Intercostal Nerve Radiofrequency for Intercostal Neuralgia: A Retrospective Cohort Study

This retrospective cohort study will review medical records of patients treated with intercostal nerve radiofrequency for intercostal neuralgia. The goal is to identify patient and clinical factors that are associated with treatment success after the procedure. Outcomes will be assessed using pain measures documented during routine follow-up visits, along with any recorded adverse events. No additional visits, tests, or interventions are required because this study uses previously collected clinical data.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This retrospective cohort study analyzed anonymized medical records of adults (≥18 years) with intercostal neuralgia (post-traumatic, postherpetic, or idiopathic) treated in Pain Clinic of Mersin University Faculty of Medicine who underwent ultrasound-guided intercostal conventional radiofrequency ablation (CRF) or pulsed radiofrequency (PRF) between January 1, 2018 and May 30, 2025.

Primary outcome is treatment response at 6 months, defined by IMMPACT criteria as a ≥50% reduction or ≥4-point decrease in NRS-11 from baseline; secondary outcomes include changes in NRS-11 over time, and exploratory analyses evaluate whether clinical factors (e.g., age, sex, pain duration, diagnosis, presence of allodynia, and number of treated intercostal levels )are associated with response using multivariable logistic regression (p < 0.05 considered statistically significant).

The findings are expected to clarify which patient and clinical characteristics are linked to better outcomes after intercostal nerve radiofrequency and to support more individualized decision-making in the management of intercostal neuralgia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Mersin
      • Mersin, Mersin, Turkey (Türkiye), 33110
        • Mersin University Faculty of Medicine, Department of Algology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (≥18 years) with intercostal neuralgia who underwent ultrasound-guided intercostal nerve radiofrequency treatment (conventional or pulsed) in routine clinical care and had documented baseline and at least 6-month follow-up NRS-11 pain scores.

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of intercostal neuralgia (post-traumatic, postherpetic, or idiopathic) with thoracic neuropathic pain for at least 1 month
  • Underwent ultrasound-guided intercostal nerve radiofrequency treatment (conventional radiofrequency ablation [CRF] or pulsed radiofrequency [PRF]) as part of routine clinical care
  • Documented baseline NRS-11 pain score prior to the procedure and follow-up NRS-11 data available through at least 6 months after treatment.

Exclusion Criteria:

  • Thoracic pain attributable to malignancy-related causes (e.g., active malignant invasion, spinal metastasis) or an intrathoracic mass
  • History of thoracic surgery at the corresponding thoracic dermatome level (e.g., thoracotomy or VATS)
  • Prior radiofrequency treatment at the same intercostal nerve site
  • Receipt of other interventional treatments targeting the intercostal nerve during the study period (e.g., cryoablation or chemical neurolysis)
  • Insufficient follow-up data (less than 6 months of follow-up NRS-11 documentation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Intercostal Nerve Radiofrequency Cohort
Adults with intercostal neuralgia who underwent ultrasound-guided intercostal nerve radiofrequency treatment (conventional or pulsed) as part of routine clinical care.
Procedure: Intercostal Nerve Conventional Radiofrequency Ablation (CRF)
Ultrasound-guided intercostal nerve lesioning at 80°C for 90 seconds following sensory stimulation.
Procedure: Intercostal Nerve Pulsed Radiofrequency (PRF)
Ultrasound-guided intercostal pulsed radiofrequency delivered at 42°C for 240 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment response at 6 months (IMMPACT-defined responder rate)
Time Frame: 6 months
Responder defined as ≥50% reduction or ≥4-point decrease in NRS-11 compared with baseline.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in NRS-11 pain score from baseline
Time Frame: Baseline, 3 months, and 6 months
NRS-11 ranges from 0 (no pain) to 10 (worst imaginable pain).
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MERSINALG-INTERCOSTALRF-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a retrospective study based on de-identified patient records. No individual participant data (IPD) will be shared. Only aggregated results may be published in scientific journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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