Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome

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 )

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Procedure: Racz adhesolysis; Device: NAVI adhesolysis

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Saeid Metwaly Elsawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with history of lumbar surgery of at least 6 months duration in the past.
• Patients over the 18 years of age.
• History of persistent function-limiting lower extremity pain aggravated by "dural tug" (observed when the patient, sitting on the exam table with legs stretched out, bends forward, bringing on the back pain) with or without low back pain of at least 6 months duration after failure of conventional conservative management in most patients including NSAIDS, muscle relaxants (tizanidine, magnesium sulphate) and pregabalin.
• Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements.

Exclusion Criteria:

• Unstable or heavy opioid use.
• Uncontrolled psychiatric disorders.
• Uncontrolled medical illness.
• Any conditions that could interfere with the interpretation of the outcome assessments.
• Pregnant or lactating women.
• Patients with a history or potential for adverse reaction(s) to local anaesthetics or steroid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Raj'z catheter	Procedure: Racz adhesolysis; adhesiolysis in failed back surgery
Active Comparator: NAVI catheter	Device: NAVI adhesolysis; adhesiolysis in failed back surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	0 - 100% disability; minimal disability = 0% to either bed-bound or exaggerating symptoms = 100%)	12 month
pregabalin consumption	amount of pregabalin consumed by the patient per day	12 month

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): August 13, 2023

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: saeid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: may i share it

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes