Radicular PainNCT07487935
Determinants of Clinical Outcome After Caudal Epidural Adhesiolysis for Chronic Lumbar Radicular Pain
An observational study of Radicular Pain and Adhesiolysis, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radicular Pain, Adhesiolysis, Disc Disease Lumbar
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine, Department of Pain Medicine
Mersin, Ciftlikkoy, 33110
About this study
Official title: Determinants of Clinical Success After Caudal Epidural Adhesiolysis in Chronic Lumbar Radicular Pain: A Retrospective Cohort Study
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.
Read the detailed description
This single-center retrospective cohort study will evaluate the medical records of 40 eligible patients who underwent caudal epidural adhesiolysis at the Mersin University Algology Clinic between March 1, 2023, and January 1, 2026, for chronic lumbar radicular pain or pain related to epidural adhesions. Eligibility will be determined according to the predefined inclusion and exclusion criteria. In patients who underwent more than one procedure during the study period, only the first (index) caudal epidural adhesiolysis will be included in the analysis.
The primary focus of the study is to assess clinical success following caudal epidural adhesiolysis and to examine changes in pain and clinical improvement measures during follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10), and functional status will be evaluated using the Oswestry Disability Index (ODI) before the procedure and at follow-up visits. Analyses of clinical success and treatment-related change will be based on these outcome measures.
Potential factors associated with treatment outcome will also be examined. These variables will include demographic and clinical characteristics, such as age, sex, symptom duration, diagnosis, history of previous lumbar surgery, baseline pain severity, and prior or concurrent treatments, as well as selected procedure-related variables, including the level to which the catheter was advanced, medications administered during the procedure, and procedure-related complications.
All study data will be collected from the electronic medical record system and patient files. The study is designed to identify factors that may be associated with favorable clinical outcomes after caudal epidural adhesiolysis in patients with chronic lumbar radicular pain and to contribute to improved patient selection in interventional pain practice.
- Conditions
- Radicular Pain, Adhesiolysis, Disc Disease Lumbar
- Keywords
- Caudal Epidural Adhesiolysis, Interventional Pain Management, Epidural Fibrosis, Treatment Outcome, Lumbar Radiculopathy
- Medical subject headings
- Intervertebral disc disease, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, and 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jan 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radicular PainStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Bakır, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487935
- Sponsor's protocol ID
- MERSINALG-ADHESIOLYSIS -2026
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 28246488Kose 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.
PubMed 37834981Ege 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.
PubMed 38260106
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Clinical Success After Caudal Epidural Adhesiolysis in Chronic Lumbar Radicular Pain: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07487935
- Acronym / sponsor ID
- MERSINALG-ADHESIOLYSIS -2026
- Conditions
- Radicular Pain, Adhesiolysis, Disc Disease Lumbar
- Keywords
- Caudal Epidural Adhesiolysis, Interventional Pain Management, Epidural Fibrosis, Treatment Outcome, Lumbar Radiculopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-center retrospective cohort study will evaluate the medical records of 40 eligible patients who underwent caudal epidural adhesiolysis at the Mersin University Algology Clinic between March 1, 2023, and January 1, 2026, for chronic lumbar radicular pain or pain related to epidural adhesions. Eligibility will be determined according to the predefined inclusion and exclusion criteria. In patients who underwent more than one procedure during the study period, only the first (index) caudal epidural adhesiolysis will be included in the analysis.
The primary focus of the study is to assess clinical success following caudal epidural adhesiolysis and to examine changes in pain and clinical improvement measures during follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10), and functional status will be evaluated using the Oswestry Disability Index (ODI) before the procedure and at follow-up visits. Analyses of clinical success and treatment-related change will be based on these outcome measures.
Potential factors associated with treatment outcome will also be examined. These variables will include demographic and clinical characteristics, such as age, sex, symptom duration, diagnosis, history of previous lumbar surgery, baseline pain severity, and prior or concurrent treatments, as well as selected procedure-related variables, including the level to which the catheter was advanced, medications administered during the procedure, and procedure-related complications.
All study data will be collected from the electronic medical record system and patient files. The study is designed to identify factors that may be associated with favorable clinical outcomes after caudal epidural adhesiolysis in patients with chronic lumbar radicular pain and to contribute to improved patient selection in interventional pain practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical success based on change in pain intensity measured by the Numeric Rating Scale (NRS)
Time frame: Baseline, 1 month, and 3 months after the procedure
Pain intensity will be assessed using the Numeric Rating Scale (0-10) before caudal epidural adhesiolysis and during follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 28246488Moon 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.
- Background: PubMed 37834981Kose 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.
- Background: PubMed 38260106Ege 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radicular Pain and Adhesiolysis, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success based on change in pain intensity measured by the Numeric Rating Scale (NRS) (time frame: Baseline, 1 month, and 3 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07487935, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.