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

NCT ID: NCT05018377

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-08-13

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.

Conditions

Failed Back Surgery Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Raj'z catheter

Group Type: ACTIVE_COMPARATOR

Racz adhesolysis

Intervention Type: PROCEDURE

adhesiolysis in failed back surgery

NAVI catheter

Group Type: ACTIVE_COMPARATOR

NAVI adhesolysis

Intervention Type: DEVICE

adhesiolysis in failed back surgery

Interventions

Racz adhesolysis

adhesiolysis in failed back surgery

Intervention Type: PROCEDURE

NAVI adhesolysis

adhesiolysis in failed back surgery

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Saeid Metwaly Abouelyazid Elsawy

lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saeid Metwaly Elsawy

Asyut, , Egypt

Countries

Egypt

Other Identifiers

saeid

Identifier Type: -

Identifier Source: org_study_id