- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367152
Predictors of Success After Intercostal Nerve Radiofrequency Treatment for Intercostal Neuralgia (ICN-RF-IN)
Predictors of Treatment Success After Intercostal Nerve Radiofrequency for Intercostal Neuralgia: A Retrospective Cohort Study
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Mersin
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Mersin, Mersin, Turkey (Türkiye), 33110
- Mersin University Faculty of Medicine, Department of Algology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Ultrasound-guided intercostal nerve lesioning at 80°C for 90 seconds following sensory stimulation.
Ultrasound-guided intercostal pulsed radiofrequency delivered at 42°C for 240 seconds.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment response at 6 months (IMMPACT-defined responder rate)
Time Frame: 6 months
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Responder defined as ≥50% reduction or ≥4-point decrease in NRS-11 compared with baseline.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in NRS-11 pain score from baseline
Time Frame: Baseline, 3 months, and 6 months
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NRS-11 ranges from 0 (no pain) to 10 (worst imaginable pain).
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Baseline, 3 months, and 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Huang X, Ma Y, Wang W, Guo Y, Xu B, Ma K. Efficacy and safety of pulsed radiofrequency modulation of thoracic dorsal root ganglion or intercostal nerve on postherpetic neuralgia in aged patients: a retrospective study. BMC Neurol. 2021 Jun 24;21(1):233. doi: 10.1186/s12883-021-02286-6.
- Engel AJ. Utility of intercostal nerve conventional thermal radiofrequency ablations in the injured worker after blunt trauma. Pain Physician. 2012 Sep-Oct;15(5):E711-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MERSINALG-INTERCOSTALRF-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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