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

NCT05018377 | Completed DMC FDA Device

• 1 other identifier: saeid
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 )

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oswestry Disability Index (ODI)

  12 month

• pregabalin consumption

  12 month

Study Arms (2)

Raj'z catheter

ACTIVE COMPARATOR

Procedure: Racz adhesolysis

NAVI catheter

ACTIVE COMPARATOR

Device: NAVI adhesolysis

Interventions

Racz adhesolysis PROCEDURE

adhesiolysis in failed back surgery

Raj'z catheter

NAVI adhesolysis DEVICE

adhesiolysis in failed back surgery

NAVI catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Saeid Metwaly Elsawy

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: August 24, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: August 13, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

EG (1)