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OpenTrials
Completed

NCT Number: NCT05018377

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 )

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saeid Metwaly Elsawy

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Racz adhesolysis

Procedure

adhesiolysis in failed back surgery

NAVI adhesolysis

Device

adhesiolysis in failed back surgery

Primary outcomes

  1. numerical rating scale

    Time frame: 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 outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 12 month

    0 - 100% disability; minimal disability = 0% to either bed-bound or exaggerating symptoms = 100%)

  2. pregabalin consumption

    Time frame: 12 month

    amount of pregabalin consumed by the patient per day

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 24, 2021
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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