NCT02459392

Brief Summary

In this prospective multi-centre double-blind trial the effect of the epiduroscopy will be examined in (approximately 300) adult patients with low back pain pain caused by failed back surgery syndrome (FBSS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

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

May 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
6.6 years until next milestone

Study Start

First participant enrolled

December 31, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

Same day

First QC Date

May 26, 2015

Last Update Submit

December 30, 2021

Conditions

Lumbar Spinal Stenosis

Keywords

Epiduroscopy,Failed back surgery syndromeSpinal Stenosis with neurologic changes

Outcome Measures

Primary Outcomes (1)

  • Pain as assessed by the Visual analogue scale

    All acquired information will be noted in to the special anonymous protocol

    3 years

Secondary Outcomes (3)

  • Pain progress as assessed by global pain scale

    3 years

  • Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids

    3 years

  • Pain localization as assessed by note of radiating dermatome as neurologic examination

    3 years

Study Arms (4)

Epiduroscopy mechanical lysis - failed back surgery syndrome

OTHER

Epiduroscopy only mechanical lysis

Other: Epiduroscopy

Epiduroscopy combination - failed back surgery syndrome

EXPERIMENTAL

Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg

Other: EpiduroscopyDrug: Hyaluronic AcidDrug: DepoMedrol

Epiduroscopy mechanical lysis - chronic low back pain without previous spine surgery

OTHER

Epiduroscopy only mechanical lysis

Other: Epiduroscopy

Epiduroscopy combination - chronic low back pain without previous spine surgery

EXPERIMENTAL

Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg

Other: EpiduroscopyDrug: Hyaluronic AcidDrug: DepoMedrol

Interventions

EpiduroscopyOTHER

Epiduroscopy has two main uses in the pain clinic: Releasing epidural adhesions for the relief of chronic sciatica. Adhesions can form around the lower lumbar nerve roots after decompressive surgery for disc disease or after a bad bout of inflammatory sciatica in the absence of surgery. Epidural adhesions can usually be identified on an enhanced magnetic resonance scan using intravenous gadolinium. They also cause uneven spread of X-ray contrast when performing an epidurogram. Injecting mixtures of local anesthetic and depot steroid around inflamed nerve roots when epidural injections / nerve root blocks have been unsuccessful. The presence of adhesions can prevent epidurally injected drugs from reaching the inflamed nerve roots.

Epiduroscopy combination - chronic low back pain without previous spine surgeryEpiduroscopy combination - failed back surgery syndromeEpiduroscopy mechanical lysis - chronic low back pain without previous spine surgeryEpiduroscopy mechanical lysis - failed back surgery syndrome
Hyaluronic AcidDRUG

Drug administration

Epiduroscopy combination - chronic low back pain without previous spine surgeryEpiduroscopy combination - failed back surgery syndrome
DepoMedrolDRUG

Drug administration

Epiduroscopy combination - chronic low back pain without previous spine surgeryEpiduroscopy combination - failed back surgery syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 years or older
  • Written informed consent
  • Patients with FBSS
  • Magnetic resonance examination evidence of intervertebral disc herniation
  • Permanent pain radiating to lower limbs despite previous periradicular therapy or caudal block
  • Actual Magnetic resonance imaging: lesion without serious spinal stenosis, lesion without serious radicular compression, lesion without serious intervertebral disc herniation

You may not qualify if:

  • Patients not capable of consenting
  • Pregnant women or women of child-bearing potential
  • Cauda equine syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Czech republic

Prague, Czechia

Location

MeSH Terms

Conditions

Spinal StenosisFailed Back Surgery Syndrome

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Juraj Mláka, MD PhD

    R-Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 2, 2015

Study Start

December 31, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12

Locations

CZ(1)