EuroPainClinics® Study II (Prospective Randomized Double Blinded Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Europainclinics z.ú.
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Pain as assessed by the Visual analogue scale
Study Overview
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).
Detailed Description
A small flexible fibreoptic catheter is inserted in sacral hiatus and the areas of concern can be visualized on the screen. Effective drugs like active enzyme: Hyaluronic acid and corticosteroids then can be injected through the same catheter.
With this method we can eliminate adhesions or scar tissue that may be pulling or irritating specific nerve roots.
Indicated for this procedure are patients with low back pain or sciatic patients who have not had a successful result with back surgery or spine surgery and have experienced continued pain after surgery: Failed back surgery syndrome (FBSS). Trial will compare groups of patients after fulfilment inclusion with Failed back surgery syndrome who will undergo interventional pain release procedure epiduroscopy. Elimination of adhesions, or scar tissue will be provided mechanically (grabbers, balloon techniques, by radiofrequency or laser) and with medical support (Hyaluronic acid and Depo-Medrol administration via epidural catheter).
The first group of patients enrolled in to the trial will undergo only mechanical lysis of epidural adhesions (grabbers, balloon techniques, by radiofrequency or laser).
The second group of patients enrolled in to the trial will undergo mechanical lysis of epidural adhesions together with epidural drug administration (Hyaluronic acid 150 IU and Depo-Medrol 80mg).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients not capable of consenting
- •Pregnant women or women of child-bearing potential
- •Cauda equine syndrome
Arms & Interventions
Epiduroscopy mechanical lysis - failed back surgery syndrome
Epiduroscopy only mechanical lysis
Intervention: Epiduroscopy (Other)
Epiduroscopy combination - failed back surgery syndrome
Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg
Intervention: Epiduroscopy (Other)
Epiduroscopy combination - failed back surgery syndrome
Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg
Intervention: Hyaluronic Acid (Drug)
Epiduroscopy combination - failed back surgery syndrome
Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg
Intervention: DepoMedrol (Drug)
Epiduroscopy mechanical lysis - chronic low back pain without previous spine surgery
Epiduroscopy only mechanical lysis
Intervention: Epiduroscopy (Other)
Epiduroscopy combination - chronic low back pain without previous spine surgery
Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg
Intervention: Epiduroscopy (Other)
Epiduroscopy combination - chronic low back pain without previous spine surgery
Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg
Intervention: Hyaluronic Acid (Drug)
Epiduroscopy combination - chronic low back pain without previous spine surgery
Epiduroscopy together mechanical lysis of epidural adhesions together with epidural drug administration Hyaluronic acid 150 IU and Depo-Medrol 80mg
Intervention: DepoMedrol (Drug)
Outcomes
Primary Outcomes
Pain as assessed by the Visual analogue scale
Time Frame: 3 years
All acquired information will be noted in to the special anonymous protocol
Secondary Outcomes
- 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)