NCT07487935

Brief Summary

Chronic lumbar radicular pain is a frequently encountered condition that can cause marked pain, limited physical function, and a substantial decline in quality of life. For patients whose symptoms do not respond adequately to conservative treatment, caudal epidural adhesiolysis is considered a minimally invasive treatment option, particularly when epidural fibrosis or adhesions are thought to contribute to persistent pain. Even so, treatment response after caudal epidural adhesiolysis is not the same for every patient. Some individuals experience meaningful clinical improvement, whereas others obtain limited benefit. Understanding which factors are associated with a favorable outcome may help clinicians make better treatment decisions and identify patients who are more likely to benefit from the procedure. In this single-center retrospective cohort study, we reviewed the medical records of patients with chronic lumbar radicular pain who underwent caudal epidural adhesiolysis. The purpose of the study is to evaluate clinical success after the procedure and to explore demographic, clinical, and procedure-related factors that may influence treatment outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

January 1, 2023

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 17, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

Caudal Epidural AdhesiolysisInterventional Pain ManagementEpidural FibrosisTreatment OutcomeLumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • Clinical success based on change in pain intensity measured by the Numeric Rating Scale (NRS)

    Pain intensity will be assessed using the Numeric Rating Scale (0-10) before caudal epidural adhesiolysis and during follow-up.

    Baseline, 1 month, and 3 months after the procedure

Study Arms (1)

Patients Undergoing Caudal Epidural Adhesiolysis

This cohort consists of eligible patients with chronic lumbar radicular pain or pain related to epidural adhesions who underwent caudal epidural adhesiolysis during the study period. Only the first procedure was included for patients with repeated interventions. Clinical outcomes were assessed using pain and functional status measures recorded before the procedure and during follow-up.

Eligibility Criteria

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

The study population consists of adult patients with chronic lumbar radicular pain or pain related to epidural adhesions who underwent caudal epidural adhesiolysis at the Mersin University Faculty of Medicine, Algology Clinic between March 1, 2023, and January 1, 2026. Only patients who met the predefined inclusion and exclusion criteria and had available pre-procedural, procedural, and post-procedural follow-up data, including Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) scores, were included in the analysis.

You may qualify if:

  • Age 18 years or older
  • Underwent caudal epidural adhesiolysis at the Mersin University Faculty of Medicine, Algology Clinic between March 1, 2023, and January 1, 2026
  • Evaluated with a diagnosis of chronic lumbar radicular pain or pain related to epidural adhesions
  • Availability of pre-procedural clinical data in the medical records
  • Availability of procedural technical records in the medical file, including at minimum the procedure date, the level to which the catheter was advanced, and the medications administered and/or procedural details
  • Availability of post-procedural follow-up data including Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) scores

You may not qualify if:

  • Patients younger than 18 years
  • Patients who underwent caudal epidural adhesiolysis outside the period from March 1, 2023, to January 1, 2026, at the Mersin University Faculty of Medicine, Algology Clinic
  • Patients without a diagnosis of chronic lumbar radicular pain or pain related to epidural adhesions
  • Missing essential pre-procedural clinical data in the medical records
  • Insufficient procedural technical documentation in the medical file
  • Absence of post-procedural clinical follow-up data
  • Missing Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI) scores in the follow-up records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Medicine, Department of Pain Medicine

Mersin, Ciftlikkoy, 33110, Turkey (Türkiye)

Location

Related Publications (3)

  • Moon SH, Lee JI, Cho HS, Shin JW, Koh WU. Factors for Predicting Favorable Outcome of Percutaneous Epidural Adhesiolysis for Lumbar Disc Herniation. Pain Res Manag. 2017;2017:1494538. doi: 10.1155/2017/1494538. Epub 2017 Jan 26.

    PMID: 28246488BACKGROUND
  • Kose HC, Akkaya OT. Predictive Factors Associated with Successful Response to Percutaneous Adhesiolysis in Chronic Lumbar Radicular Pain. J Clin Med. 2023 Oct 3;12(19):6337. doi: 10.3390/jcm12196337.

    PMID: 37834981BACKGROUND
  • Ege F. Evaluation of the Efficacy of Caudal Epidural Neuroplasty in Patients With Lumbar Epidural Fibrosis. Cureus. 2024 Jan 20;16(1):e52606. doi: 10.7759/cureus.52606. eCollection 2024 Jan.

    PMID: 38260106BACKGROUND

MeSH Terms

Conditions

Intervertebral disc diseaseRadiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

January 1, 2023

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available because the study is based on retrospectively collected medical record data from a single center, and sharing such data may raise confidentiality and privacy concerns.

Locations