Back to resultsEffectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome
Primary Purpose
Failed Back Surgery Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Racz adhesolysis
NAVI adhesolysis
Sponsored by
About this trial
This is an interventional treatment trial for Failed Back Surgery Syndrome
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.
Sites / Locations
- Saeid Metwaly Elsawy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Raj'z catheter
NAVI catheter
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05018377
Brief Title
Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome
Official Title
Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
January 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raj'z catheter
Arm Type
Active Comparator
Arm Title
NAVI catheter
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Racz adhesolysis
Intervention Description
adhesiolysis in failed back surgery
Intervention Type
Device
Intervention Name(s)
NAVI adhesolysis
Intervention Description
adhesiolysis in failed back surgery
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Saeid Metwaly Elsawy
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
may i share it
Learn more about this trial
Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome
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