Failed Back Surgery SyndromeEPCS IXNCT07411950
EuroPainClinicsStudy IX ( EPCS IX )
A study testing Epiduroscopic mechanical adhesiolysis and Epidural pharmacologic therapy in people with Failed Back Surgery Syndrome and Lumbar Radiculopathy, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
This prospective investigator-initiated study compares the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with failed back surgery syndrome (FBSS) and in patients with lumbar radicular pain without prior lumbar surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Failed Back Surgery Syndrome, Lumbar Radiculopathy, Chronic Low Back Pain
- What is being tested?
- Epiduroscopic mechanical adhesiolysis and Epidural pharmacologic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Jan 2021to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80 years
- Chronic lumbosacral radicular pain persisting ≥ 6 months despite conservative treatment
- Failed back surgery syndrome (FBSS) with history of 1-2 prior lumbar laminectomies or surgery-naïve patients without prior lumbar surgery
- Lower extremity radicular pain with baseline pain intensity ≥ 5 on a 0-10 Numeric Rating Scale
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- More than two prior lumbar spine surgeries
- Significant spinal pathology other than degenerative disease (e.g., fracture, tumor, infection, inflammatory spondylitis)
- Progressive neurological deficit
- Pregnancy or planned pregnancy during the study period
- Severe systemic illness or contraindication to epidural intervention
- Known allergy to study medications (steroids, hyaluronidase, or saline)
- Inability to complete follow-up assessments
- Any condition judged by investigators to make participation unsafe
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparative Study of Epiduroscopic Adhesiolysis in Patients With Failed Back Surgery Syndrome and Patients Without Prior Lumbar Surgery
This prospective investigator-initiated study compares the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with failed back surgery syndrome (FBSS) and in patients with lumbar radicular pain without prior lumbar surgery. Epiduroscopy allows direct visualization of the epidural space with targeted mechanical adhesiolysis and optional epidural pharmacologic treatment. The primary objective is to evaluate pain relief and functional improvement following the procedure. Secondary outcomes include disability scores, quality of life, and procedure-related complications. The study aims to determine whether prior lumbar surgery influences clinical outcomes after epiduroscopic treatment.
Read the detailed description
This investigator-initiated prospective, multicenter, randomized, double-blind controlled study was conducted at certified interventional pain centers in Slovakia to evaluate the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with chronic lumbar radicular pain. The protocol was approved by regional ethics committees, and all participants provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles.
Eligible participants were adults with chronic lumbosacral radicular pain persisting for more than six months despite conservative treatment. Patients were enrolled into two predefined clinical cohorts according to surgical history: (1) failed back surgery syndrome (FBSS), defined as persistent or recurrent radicular pain following lumbar spine surgery, and (2) surgery-naïve patients without prior lumbar surgery. Cohort allocation was performed prior to randomization, while all other eligibility criteria were identical across groups.
Within each cohort, participants were randomized in a 1:1 ratio to undergo either epiduroscopic mechanical adhesiolysis alone or mechanical adhesiolysis combined with targeted epidural pharmacologic therapy. Randomization was computer-generated and stratified by study center. The study was double-blinded; patients and outcome assessors were unaware of treatment assignment, while the operating physician did not participate in follow-up evaluations.
All procedures were performed via a sacral epidural approach under fluoroscopic guidance using a flexible epiduroscope. Mechanical adhesiolysis consisted of endoscopic dissection and saline irrigation to release epidural adhesions around symptomatic nerve roots. In the pharmacologic treatment groups, adhesiolysis was followed by epidural administration of methylprednisolone acetate (40 mg), hyaluronidase (1,500 IU), and hypertonic saline (10 mL). In the mechanical-only groups, isotonic saline was administered to maintain blinding. Procedural and perioperative management were standardized across centers.
Clinical assessments were performed at baseline and at 6 months after the procedure. Outcomes included pain intensity measured by the Numeric Rating Scale (NRS), health-related quality of life assessed using EQ-VAS and EQ-5D-5L, functional status, analgesic consumption, and procedure-related adverse events. All evaluations were conducted by blinded assessors.
Statistical analyses followed the intention-to-treat principle, and differences between groups and time points were analyzed using appropriate statistical methods.
- Conditions
- Failed Back Surgery Syndrome, Lumbar Radiculopathy, Chronic Low Back Pain, Epidural Fibrosis
- Being tested
- Epiduroscopic mechanical adhesiolysis, Epidural pharmacologic therapy
- Keywords
- Epiduroscopy, Epiduroscopic adhesiolysis, Percutaneous epidural neurolysis, Mechanical adhesiolysis, Chronic radicular pain, Failed back surgery syndrome
- Medical subject headings
- Failed Back Surgery Syndrome, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiduroscopic mechanical adhesiolysisProcedure or surgery
Percutaneous epiduroscopy performed via a sacral approach under fluoroscopic guidance using a flexible epiduroscope. Mechanical dissection and saline irrigation were used to release epidural fibrotic adhesions and decompress symptomatic nerve roots.
Epidural pharmacologic therapyDrug
Targeted epidural administration of methylprednisolone acetate (40 mg), hyaluronidase (1,500 IU), and hypertonic saline (10 mL) delivered under fluoroscopic or endoscopic guidance following mechanical adhesiolysis.
| Study group | Role | What they receive |
|---|---|---|
| FBSS - Mechanical Adhesiolysis | Experimental | Participants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis only. Receives: Procedure: Epiduroscopic mechanical adhesiolysis |
| FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy | Experimental | Participants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural administration of methylprednisolone, hyaluronidase, and hypertonic saline. Receives: Procedure: Epiduroscopic mechanical adhesiolysis; Drug: Epidural pharmacologic therapy |
| Surgery-Naïve - Mechanical Adhesiolysis | Experimental | Participants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis only. Receives: Procedure: Epiduroscopic mechanical adhesiolysis |
| Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy | Experimental | Participants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural pharmacologic therapy. Receives: Procedure: Epiduroscopic mechanical adhesiolysis; Drug: Epidural pharmacologic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related quality of life measured by EQ-5D-5L index value
Change from baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) index score. Higher scores indicate better health status.
Measured: 6 months
Change in leg pain intensity measured by Numeric Rating Scale (NRS)
Change from baseline in leg pain intensity measured on an 11-point scale.
Measured: 6 months
Change in back pain intensity measured by Numeric Rating Scale (NRS)
Change from baseline in back pain intensity measured on an 11-point scale (0 = no pain, 10 = worst imaginable pain).
Measured: 6 months
Change in disability measured by Oswestry Disability Index (ODI)
Change from baseline in functional disability assessed using the Oswestry Disability Index (0-100%), with higher scores indicating greater disability.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Jan 2021
- Primary completion31 May 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were first allocated to predefined clinical cohorts according to prior lumbar surgery status (failed back surgery syndrome or surgery-naïve). Within each cohort, patients were randomized in a 1:1 ratio to receive either mechanical epiduroscopic adhesiolysis alone or mechanical adhesiolysis combined with epidural pharmacologic therapy. All groups were treated and followed in parallel.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- Slovak Academy of Sciences, East Slovak Institute for Cardiovascular Diseases
- Responsible party
- Principal investigator, MUDr. Miroslav Buriánek MBA, MUDr. Robert Rapčan FIPP, EPC Education s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411950
- Sponsor's protocol ID
- EK 03595/2020/OZ-30
- Acronym
- EPCS IX
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Epiduroscopic Adhesiolysis in Patients With Failed Back Surgery Syndrome and Patients Without Prior Lumbar Surgery
- ClinicalTrials.gov ID
- NCT07411950
- Acronym / sponsor ID
- EPCS IX / EK 03595/2020/OZ-30
- Conditions
- Failed Back Surgery Syndrome, Lumbar Radiculopathy, Chronic Low Back Pain, Epidural Fibrosis
- Keywords
- Epiduroscopy, Epiduroscopic adhesiolysis, Percutaneous epidural neurolysis, Mechanical adhesiolysis, Chronic radicular pain, Failed back surgery syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Collaborators
- Slovak Academy of Sciences, East Slovak Institute for Cardiovascular Diseases
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 17 Feb 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.
This prospective investigator-initiated study compares the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with failed back surgery syndrome (FBSS) and in patients with lumbar radicular pain without prior lumbar surgery. Epiduroscopy allows direct visualization of the epidural space with targeted mechanical adhesiolysis and optional epidural pharmacologic treatment. The primary objective is to evaluate pain relief and functional improvement following the procedure. Secondary outcomes include disability scores, quality of life, and procedure-related complications. The study aims to determine whether prior lumbar surgery influences clinical outcomes after epiduroscopic treatment.
Detailed description
This investigator-initiated prospective, multicenter, randomized, double-blind controlled study was conducted at certified interventional pain centers in Slovakia to evaluate the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with chronic lumbar radicular pain. The protocol was approved by regional ethics committees, and all participants provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles.
Eligible participants were adults with chronic lumbosacral radicular pain persisting for more than six months despite conservative treatment. Patients were enrolled into two predefined clinical cohorts according to surgical history: (1) failed back surgery syndrome (FBSS), defined as persistent or recurrent radicular pain following lumbar spine surgery, and (2) surgery-naïve patients without prior lumbar surgery. Cohort allocation was performed prior to randomization, while all other eligibility criteria were identical across groups.
Within each cohort, participants were randomized in a 1:1 ratio to undergo either epiduroscopic mechanical adhesiolysis alone or mechanical adhesiolysis combined with targeted epidural pharmacologic therapy. Randomization was computer-generated and stratified by study center. The study was double-blinded; patients and outcome assessors were unaware of treatment assignment, while the operating physician did not participate in follow-up evaluations.
All procedures were performed via a sacral epidural approach under fluoroscopic guidance using a flexible epiduroscope. Mechanical adhesiolysis consisted of endoscopic dissection and saline irrigation to release epidural adhesions around symptomatic nerve roots. In the pharmacologic treatment groups, adhesiolysis was followed by epidural administration of methylprednisolone acetate (40 mg), hyaluronidase (1,500 IU), and hypertonic saline (10 mL). In the mechanical-only groups, isotonic saline was administered to maintain blinding. Procedural and perioperative management were standardized across centers.
Clinical assessments were performed at baseline and at 6 months after the procedure. Outcomes included pain intensity measured by the Numeric Rating Scale (NRS), health-related quality of life assessed using EQ-VAS and EQ-5D-5L, functional status, analgesic consumption, and procedure-related adverse events. All evaluations were conducted by blinded assessors.
Statistical analyses followed the intention-to-treat principle, and differences between groups and time points were analyzed using appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants were first allocated to predefined clinical cohorts according to prior lumbar surgery status (failed back surgery syndrome or surgery-naïve). Within each cohort, patients were randomized in a 1:1 ratio to receive either mechanical epiduroscopic adhesiolysis alone or mechanical adhesiolysis combined with epidural pharmacologic therapy. All groups were treated and followed in parallel.
| Arm | Type | Receives |
|---|---|---|
| FBSS - Mechanical Adhesiolysis | Experimental | Procedure: Epiduroscopic mechanical adhesiolysisParticipants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis only. |
| FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy | Experimental | Procedure: Epiduroscopic mechanical adhesiolysis, Drug: Epidural pharmacologic therapyParticipants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural administration of methylprednisolone, hyaluronidase, and hypertonic saline. |
| Surgery-Naïve - Mechanical Adhesiolysis | Experimental | Procedure: Epiduroscopic mechanical adhesiolysisParticipants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis only. |
| Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy | Experimental | Procedure: Epiduroscopic mechanical adhesiolysis, Drug: Epidural pharmacologic therapyParticipants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural pharmacologic therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-80 years
- Chronic lumbosacral radicular pain persisting ≥ 6 months despite conservative treatment
- Failed back surgery syndrome (FBSS) with history of 1-2 prior lumbar laminectomies or surgery-naïve patients without prior lumbar surgery
- Lower extremity radicular pain with baseline pain intensity ≥ 5 on a 0-10 Numeric Rating Scale
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (8 listed)
- More than two prior lumbar spine surgeries
- Significant spinal pathology other than degenerative disease (e.g., fracture, tumor, infection, inflammatory spondylitis)
- Progressive neurological deficit
- Pregnancy or planned pregnancy during the study period
- Severe systemic illness or contraindication to epidural intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epiduroscopic mechanical adhesiolysisPercutaneous epiduroscopy performed via a sacral approach under fluoroscopic guidance using a flexible epiduroscope. Mechanical dissection and saline irrigation were used to release epidural fibrotic adhesions and decompress symptomatic nerve roots. | Procedure or surgery | FBSS - Mechanical Adhesiolysis, FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy, Surgery-Naïve - Mechanical Adhesiolysis, Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy |
| Epidural pharmacologic therapyTargeted epidural administration of methylprednisolone acetate (40 mg), hyaluronidase (1,500 IU), and hypertonic saline (10 mL) delivered under fluoroscopic or endoscopic guidance following mechanical adhesiolysis. | Drug | FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy, Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy |
Primary outcome
Change in health-related quality of life measured by EQ-5D-5L index value
Time frame: 6 months
Change from baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) index score. Higher scores indicate better health status.
Change in leg pain intensity measured by Numeric Rating Scale (NRS)
Time frame: 6 months
Change from baseline in leg pain intensity measured on an 11-point scale.
Change in back pain intensity measured by Numeric Rating Scale (NRS)
Time frame: 6 months
Change from baseline in back pain intensity measured on an 11-point scale (0 = no pain, 10 = worst imaginable pain).
Change in disability measured by Oswestry Disability Index (ODI)
Time frame: 6 months
Change from baseline in functional disability assessed using the Oswestry Disability Index (0-100%), with higher scores indicating greater disability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Epiduroscopic mechanical adhesiolysis and Epidural pharmacologic therapy in people with Failed Back Surgery Syndrome and Lumbar Radiculopathy, run by EPC Education s.r.o. at 1 site in Slovakia.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 17 Feb 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 Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in health-related quality of life measured by EQ-5D-5L index value (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.