Failed Back Surgery Syndrome
Conditions
Brief summary
Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS
Detailed description
I. Epiduroscopy is an advanced proven diagnostic and therapeutic method for chronic radicular pain after spinal surgery. Moreover, this method is frequently used in patients with chronic low back pain conditions without previous spine surgery also known as virgin back. Epiduroscopy allows by optical fiber technology and skiascopy imaging the exact examination of the epidural space and subsequently mechanical lysis (with advanced interventional options by laser, radiofrequency, balloon techniques etc.) and/or drug administration to the target point. II. The Racz catheter procedure is based on epidural neurolysis. It is used to release some of the adhesions or scar tissue which surround entrapped nerves in the epidural space of the spine. This state could be caused by chronic inflammatory adhesions or by healing mechanisms after spine surgery - scars. Mechanical liberation of epidural space further allows better administration and targeting of drugs as corticoids or hyaluronidase. This technique is performed under fluoroscopy imaging. Suitable epidurogram and skiascopy confirm appropriate catheter position during procedure. III. The caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach to the epidural space is popular in managing a wide variety of chronic pain conditions in adults, especially chronic low back pain syndromes. Fluoroscopy is considered as a gold standard of needle guidance during procedures in which caudal epidural injections are performed.
Interventions
PROCEDUREEpiduroscopy treatment
Device Epiduroscop, procedure mecahnical lysis, laser, radiofrequency + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) Follow-up: before procedure, 6 months and 12 months after procedure
PROCEDURERacz catheter epidural procedure
Device Racz catheter, two procedures during clinical trial observation * First procedure after enrolment into the study mechanical lysis and drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) * Second procedure after 6 months mechanical lysis + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)
PROCEDURECaudal epidural block
Technique Caudal epidural block Three procedures during clinical trial observation : * First procedure after enrolment into the study drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) * Second procedure after 4 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg) * Third procedure after 8 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg)
Sponsors
Brno University Hospital
Slovak Academy of Sciences
Pavol Jozef Safarik University
Europainclinics z.ú.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3 paralel groups: Group A Epiduroscopy in patients with FBSS (50 patients) Group B Racz catheter epidural procedure in patients with FBSS (50 patients) Group C Caudal epidural block in patients with FBSS (50 patients)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients aged between 20 and 80 * patients with FBSS (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (VAS \>=5) on lower extremities * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form
Exclusion criteria
* more than 2 lumbar laminectomies * patients without previous spine surgery * patients with a history of other spinal diseases (compression fracture, spondylitis, tumor) * women with a positive pregnancy test before the trial or who planned to become pregnant within the following 3 years * other patients viewed as inappropriate by the staff * disagreement with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry disability index (ODI) 12m | 12 months follow-up | he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms. |
| Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m | 6 months follow-up | VAS 10 point measurement |
| Change from baseline Visual Analog Pain Scale (VAS) of back pain 12 m | 12 months follow-up | VAS 10 point measurement |
| Oswestry disability index (ODI) 6m | 6 months follow-up | he ODI self-administered questionnaire measuring 0-100 scale function.'' The questionnaire comprises 10 items, each with 6 levels of response. Each item is scored from 0 to 5, and the total summation is converted to a 0-100 scale. The ODI scores range from 0 to 100, with higher scores indicating severe symptoms. |
| Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m | 6 months follow-up | EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression |
| Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m | 12 months follow-up | EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprocedural drug usage | before procedure | drug usage |
| Radiation exposure | 12 months follow-up | Dose of radiation exposure |
| Before procedure drug usage | before procedure | drug usage |
Countries
Slovakia
Outcome results
None listed