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

Failed Back Surgery Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05018377
• Other study ID #: saeid
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 13, 2023

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 )

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 13, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Procedure:
• Racz adhesolysis
adhesiolysis in failed back surgery

Device:
• NAVI adhesolysis
adhesiolysis in failed back surgery

Locations

Country	Name	City	State
Egypt	Saeid Metwaly Elsawy	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue 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