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

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Procedure: Racz adhesolysis; Device: NAVI adhesolysis

• Registration Number: NCT05018377
• Lead Sponsor: Assiut University

Brief Summary

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 )

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 Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-24
• Study Start: 2021-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-08-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Raj'z catheter	Racz adhesolysis	-
NAVI catheter	NAVI adhesolysis	-

Primary Outcome Measures

Name	Time	Method
numerical rating scale	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Saeid Metwaly Elsawy; 🇪🇬 Assiut, Egypt