EuroPainClinicsStudy IX
Condition: Failed Back Surgery Syndrome
MeSH terms: Failed Back Surgery Syndrome
Study type: Interventional

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.
    

Intervention name(s): Epiduroscopy treatment; Racz catheter epidural procedure; Caudal epidural block
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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; 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); 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)
Allocation: Randomized
Intervention model: Parallel Assignment
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)
Masking: None (Open Label)
Primary purpose: Treatment