NCT06903949

Brief Summary

This study aims to evaluate the treatment response and lumbar magnetic resonance imaging (MRI) findings of patients who have undergone pulsed radiofrequency therapy for chronic radicular lumbar pain at the dorsal root ganglia. By comparing young (18-64 years) and geriatric (≥65 years) patient groups, the study seeks to assess the impact of age on treatment response and opioid consumption. Additionally, it aims to analyze the potential relationship between paraspinal muscle fat infiltration and treatment outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 24, 2025

Last Update Submit

March 29, 2025

Conditions

Keywords

Radiculopathy LumbarRadiculopathy, Lumbosacral RegionChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    Numeric Rating Scale is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

    Change from baseline to third month after treatment

Secondary Outcomes (1)

  • Goutallier Classification

    Pre-procedure grade

Study Arms (2)

Young

Young group (18-64 years): These patients undergo Pulsed Radiofrequency therapy at the lumbar dorsal root ganglia, with treatment response and opioid consumption assessed post-procedure.

Procedure: Lumbar Dorsal Root Ganglia Pulsed Radiofrequency

Geriatric

Geriatric group (≥65 years): These patients undergo Pulsed Radiofrequency therapy at the lumbar dorsal root ganglia, with treatment response and opioid consumption assessed post-procedure.

Procedure: Lumbar Dorsal Root Ganglia Pulsed Radiofrequency

Interventions

It is an interventional pain management technique used to treat chronic radicular pain, often associated with conditions like lumbar disc herniation or degenerative disc disease. It involves the application of pulsed radiofrequency energy to the dorsal root ganglia (DRG), which are clusters of nerve cell bodies located just outside the spinal cord. DRG is involved in transmitting sensory signals from the periphery (e.g., the limbs) to the central nervous system.

GeriatricYoung

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population includes patients who underwent pulsed radiofrequency (PRF) therapy at the lumbar dorsal root ganglia for chronic radicular lumbar pain. Participants are divided into two age groups: young group (18-64 years) and geriatric group (65 years and older). Only patients who have not responded well to medical and conservative treatments for their chronic radicular lumbar pain and have not undergone prior surgery will be included.

You may qualify if:

  • years of age or older patients
  • Patients that diagnosed with chronic radicular lumbar pain
  • Have not received adequate response despite conservative treatments
  • Have complete medical data available in the hospital data system

You may not qualify if:

  • Missing data in the patient's follow-up records
  • The patient has previously undergone interventional pain management
  • The patient has previously had lumbar surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Etlik, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

RadiculopathyChronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 1, 2025

Study Start

May 15, 2025

Primary Completion

October 15, 2025

Study Completion

December 15, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations