Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:26 AM
Study NCT ID:
NCT07411950
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EuroPainClinicsStudy IX ( EPCS IX )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055111', 'term': 'Failed Back Surgery Syndrome'}, {'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and outcome assessors were blinded to treatment allocation. Mechanical-only groups received epidural isotonic saline to maintain blinding. The interventional physician performing the procedure was aware of allocation but was not involved in follow-up assessments or outcome evaluation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in health-related quality of life measured by EQ-5D-5L index value', 'timeFrame': '6 months', 'description': 'Change from baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L) index score. Higher scores indicate better health status.'}, {'measure': 'Change in leg pain intensity measured by Numeric Rating Scale (NRS)', 'timeFrame': '6 months', 'description': 'Change from baseline in leg pain intensity measured on an 11-point scale.'}, {'measure': 'Change in back pain intensity measured by Numeric Rating Scale (NRS)', 'timeFrame': '6 months', 'description': 'Change from baseline in back pain intensity measured on an 11-point scale (0 = no pain, 10 = worst imaginable pain).'}, {'measure': 'Change in disability measured by Oswestry Disability Index (ODI)', 'timeFrame': '6 months', 'description': 'Change from baseline in functional disability assessed using the Oswestry Disability Index (0-100%), with higher scores indicating greater disability.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epiduroscopy', 'Epiduroscopic adhesiolysis', 'Percutaneous epidural neurolysis', 'Mechanical adhesiolysis', 'Chronic radicular pain', 'Failed back surgery syndrome'], 'conditions': ['Failed Back Surgery Syndrome', 'Lumbar Radiculopathy', 'Chronic Low Back Pain', 'Epidural Fibrosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEligible 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.\n\nWithin 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.\n\nAll 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.\n\nClinical 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.\n\nStatistical analyses followed the intention-to-treat principle, and differences between groups and time points were analyzed using appropriate statistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-80 years\n* Chronic lumbosacral radicular pain persisting ≥ 6 months despite conservative treatment\n* Failed back surgery syndrome (FBSS) with history of 1-2 prior lumbar laminectomies or surgery-naïve patients without prior lumbar surgery\n* Lower extremity radicular pain with baseline pain intensity ≥ 5 on a 0-10 Numeric Rating Scale\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* More than two prior lumbar spine surgeries\n* Significant spinal pathology other than degenerative disease (e.g., fracture, tumor, infection, inflammatory spondylitis)\n* Progressive neurological deficit\n* Pregnancy or planned pregnancy during the study period\n* Severe systemic illness or contraindication to epidural intervention\n* Known allergy to study medications (steroids, hyaluronidase, or saline)\n* Inability to complete follow-up assessments\n* Any condition judged by investigators to make participation unsafe'}, 'identificationModule': {'nctId': 'NCT07411950', 'acronym': 'EPCS IX', 'briefTitle': 'EuroPainClinicsStudy IX ( EPCS IX )', 'organization': {'class': 'OTHER', 'fullName': 'EPC Education s.r.o.'}, 'officialTitle': 'Prospective Comparative Study of Epiduroscopic Adhesiolysis in Patients With Failed Back Surgery Syndrome and Patients Without Prior Lumbar Surgery', 'orgStudyIdInfo': {'id': 'EK 03595/2020/OZ-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FBSS - Mechanical Adhesiolysis', 'description': 'Participants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis only.', 'interventionNames': ['Procedure: Epiduroscopic mechanical adhesiolysis']}, {'type': 'EXPERIMENTAL', 'label': 'FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy', 'description': 'Participants with failed back surgery syndrome underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural administration of methylprednisolone, hyaluronidase, and hypertonic saline.', 'interventionNames': ['Procedure: Epiduroscopic mechanical adhesiolysis', 'Drug: Epidural pharmacologic therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Surgery-Naïve - Mechanical Adhesiolysis', 'description': 'Participants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis only.', 'interventionNames': ['Procedure: Epiduroscopic mechanical adhesiolysis']}, {'type': 'EXPERIMENTAL', 'label': 'Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy', 'description': 'Participants without prior lumbar surgery underwent epiduroscopic mechanical adhesiolysis followed by targeted epidural pharmacologic therapy.', 'interventionNames': ['Procedure: Epiduroscopic mechanical adhesiolysis', 'Drug: Epidural pharmacologic therapy']}], 'interventions': [{'name': 'Epiduroscopic mechanical adhesiolysis', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['FBSS - Mechanical Adhesiolysis', 'FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy', 'Surgery-Naïve - Mechanical Adhesiolysis', 'Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy']}, {'name': 'Epidural pharmacologic therapy', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['FBSS - Mechanical Adhesiolysis + Pharmacologic Therapy', 'Surgery-Naïve - Mechanical Adhesiolysis + Pharmacologic Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04011', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'University of Pavol JoSef Safarik', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EPC Education s.r.o.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Slovak Academy of Sciences', 'class': 'OTHER_GOV'}, {'name': 'East Slovak Institute for Cardiovascular Diseases', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Anesthesiology and Intensive Care', 'investigatorFullName': 'MUDr. Miroslav Buriánek MBA, MUDr. Robert Rapčan FIPP', 'investigatorAffiliation': 'EPC Education s.r.o.'}}}}