An interventional study of Racz adhesolysis and NAVI adhesolysis in Failed Back Surgery Syndrome, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
In the past decade, spine surgery rates have dramatically increased in parallel to those of other procedural interventions. Persistent pain is a common occurrence after spine surgery, with the most commonly quoted prevalence rates ranging from 10% to 40%. This pain can be classified into failure to alleviate baseline pain, pain resulting from complications (e.g., arachnoiditis and epidural adhesions), and pain that ensues several years later as a sequele to alterations in spinal architecture and biomechanics (e.g., adjacent segment discogenic or facetogenic pain) which is called failed back surgery syndrome ( FBSS )
By observing adhesions directly, the lysis of scar tissue can be carried out mechanically using some percutaneous techniques as insertion of catheters as Rac'z catheter (thin in calibre) which will be inserted through the skin under fluoroscopy guidance or using NAVI catheter (large in calibre) either fluoroscopy guided or using thin epiduroscopy. Adhesions can be disintegrated and their evaluation scores may improve.
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This study's enrollment of 60 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.
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Exclusion Criteria:
Procedure: Racz adhesolysis
Device: NAVI adhesolysis
adhesiolysis in failed back surgery
adhesiolysis in failed back surgery
numerical rating scale
The VAS score was used that has 0-10 points. The 0 point represents the painless state and a score from 1 to 3 points represents mild pain, from 4 to 6 points represents moderate pain and from 7 to 10 points represents severe pain.
Time frame: 12 months
Oswestry Disability Index (ODI)
0 - 100% disability; minimal disability = 0% to either bed-bound or exaggerating symptoms = 100%)
Time frame: 12 month
pregabalin consumption
amount of pregabalin consumed by the patient per day
Time frame: 12 month
Plan to share: Undecided — may i share it
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Assiut University