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Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

Primary Purpose

Failed Back Surgery Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
caudal adhesolysis using RACZ Catheter
caudal adhesiolysis using NAVI Catheter
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring caudal adhesiolysis, catheter type

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: previous back surgery of at least 6 months duration. age ≥ 18. failure of conventional pharmacological management. Exclusion Criteria: cauda equina syndrome. pregnant or lactating women. anti-coagulant therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Epidural Catheter

    RACZ Catheter

    NAVI catheter

    Arm Description

    procedure Will be performed under sterile precautions utilizing fluoroscopy, RK needle.patient will be placed prone with a pillow under the abdomen.The sacral area draped from the top of the iliac crest to the bottom of the buttocks.The sacral Corns and the sacral hiatus will be palpated,is in the gluteal fold opposite the affected side will be infiltrated with lidocaine16gauge RK needle will be passed through the described entry point advanced to a point below the S3foramen to prevent S3nerve root damage.Placement will be confirmed by lateral and anteroposterior fluoroscopic views and after aspiration is negative for blood and CSF10mL of iohexol will be injected under fluoroscopy.Once the needle placement is confirmed to be in the epidural space, a lumbar epidurogram will be carried out utilizing approximately2to5 mL of contrast. then the bevel of the needle should face the ventrolateral aspect of the caudal canal.

    same as procedure described above but using RACZ Catheter set

    same as procedure described above but using NAVI Catheter set

    Outcomes

    Primary Outcome Measures

    pain score
    -difference in numeric rating scale at 6 months after intervention, minmal value 0 and maximum value 100 which is worst(more pain intensity)

    Secondary Outcome Measures

    functional outcome
    The Oswestry Disability Index,minmal value 0 and maximum value 50 which is worst(complete disability)

    Full Information

    First Posted
    September 17, 2023
    Last Updated
    September 30, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06051149
    Brief Title
    Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis
    Official Title
    Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis in Failed Back Surgery Syndrome.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    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
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The approach toward FBSS involves conservative management that consists of physical therapy and medication which aims to optimize gait and posture and can improve muscle strength and physical function
    Detailed Description
    The international association for the study of pain has defined failed back syndrome as persistent pain despite spine surgery in the same topographical area. Several causes have been introduced for FBSS including pressure on the nerve root due to disc re-herniation or retained disc fragment, epidural fibrosis, acquired stenosis, and segmental instability. Thus, FBSS is a syndrome with diverse etiologies and noticeable heterogeneity among patients. However, about 20% to 36% of FBSS occur due to epidural fibrosis, which is a progressive disease. The approach toward FBSS involves conservative management that consists of physical therapy and medication which aims to optimize gait and posture and can improve muscle strength and physical function. Oral pharmacological treatment of FBSS is multimodal and increasingly controversial. Treatments include antiepileptics, non-steroidal anti-inflammatory drugs, oral steroids, antidepressants, and opioids including injections, and finally surgical options as a last line therapy. Other modalities including minimally invasive procedures like epidural injections, Epidural steroid injections (ESIs) are the most commonly performed procedure in pain clinics around the world. These can be administered primarily by three approaches: transforaminal, interlaminar, or caudally, and are indicated for symptoms of radiculopathy. Also radiofrequency ablation of nerves are often used to provide sustained relief that a diagnostic block or therapeutic injection cannot provide. Successfully targeting the intended nerve is achieved, maximizing the size of the lesion. Spinal cord stimulation (SCS) is a nother treatment modality that has shown tremendous potential in the management of FBSS. Adhesions can theoretically be lysed, thereby improving baseline pain scores and drug delivery of the ESI. Lysis of adhesions typically occurs by delivering hyaluronidase with hypertonic saline into the epidural space. The use of hyaluronidase with steroid may be more effective and have longer duration of effect than either one alone. Finally, surgical revision for FBSS is associated with a high morbidity with corresponding low rates of success. Percutaneous adhesiolysis (PA), is a minimally invasive technique, that might be useful in the treatment of chronic pain refractory to conservative treatments. The basic idea behind PA is inserting a catheter in the ventral epidural space could directly break up perineural/epidural adhesions, that act as physical barriers to the perineurally deposited drugs but also cause neural irritation predisposing to neural inflammation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Failed Back Surgery Syndrome
    Keywords
    caudal adhesiolysis, catheter type

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    double-blinded, prospective study
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Will be performed in a sterile operating room under appropriate sterile precautions with help of assistant nurse who will open catheter set before principal investigator enter the operating room and the patient will be blinded.
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Epidural Catheter
    Arm Type
    Active Comparator
    Arm Description
    procedure Will be performed under sterile precautions utilizing fluoroscopy, RK needle.patient will be placed prone with a pillow under the abdomen.The sacral area draped from the top of the iliac crest to the bottom of the buttocks.The sacral Corns and the sacral hiatus will be palpated,is in the gluteal fold opposite the affected side will be infiltrated with lidocaine16gauge RK needle will be passed through the described entry point advanced to a point below the S3foramen to prevent S3nerve root damage.Placement will be confirmed by lateral and anteroposterior fluoroscopic views and after aspiration is negative for blood and CSF10mL of iohexol will be injected under fluoroscopy.Once the needle placement is confirmed to be in the epidural space, a lumbar epidurogram will be carried out utilizing approximately2to5 mL of contrast. then the bevel of the needle should face the ventrolateral aspect of the caudal canal.
    Arm Title
    RACZ Catheter
    Arm Type
    Active Comparator
    Arm Description
    same as procedure described above but using RACZ Catheter set
    Arm Title
    NAVI catheter
    Arm Type
    Active Comparator
    Arm Description
    same as procedure described above but using NAVI Catheter set
    Intervention Type
    Procedure
    Intervention Name(s)
    caudal adhesolysis using RACZ Catheter
    Intervention Description
    caudal adhesolysis for patients with failed back surgery syndrome using RACZ Catheter under fluroscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    caudal adhesiolysis using NAVI Catheter
    Intervention Description
    caudal adhesolysis for patients with failed back surgery syndrome using NAVI Catheter under fluroscopy
    Primary Outcome Measure Information:
    Title
    pain score
    Description
    -difference in numeric rating scale at 6 months after intervention, minmal value 0 and maximum value 100 which is worst(more pain intensity)
    Time Frame
    6 months after intervention
    Secondary Outcome Measure Information:
    Title
    functional outcome
    Description
    The Oswestry Disability Index,minmal value 0 and maximum value 50 which is worst(complete disability)
    Time Frame
    6 months after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: previous back surgery of at least 6 months duration. age ≥ 18. failure of conventional pharmacological management. Exclusion Criteria: cauda equina syndrome. pregnant or lactating women. anti-coagulant therapy.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

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