Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

NCT06051149 | Unknown

• 1 other identifier: AUN1615
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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

Conditions

Failed Back Surgery Syndrome

Keywords

caudal adhesiolysis; catheter type

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months after intervention

Secondary Outcomes (1)

• functional outcome

  6 months after intervention

Study Arms (3)

Epidural Catheter

ACTIVE COMPARATOR

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.

Procedure: caudal adhesolysis using RACZ Catheter; Procedure: caudal adhesiolysis using NAVI Catheter

RACZ Catheter

ACTIVE COMPARATOR

same as procedure described above but using RACZ Catheter set

Procedure: caudal adhesolysis using RACZ Catheter

NAVI catheter

ACTIVE COMPARATOR

same as procedure described above but using NAVI Catheter set

Procedure: caudal adhesiolysis using NAVI Catheter

Interventions

caudal adhesolysis using RACZ Catheter PROCEDURE

caudal adhesolysis for patients with failed back surgery syndrome using RACZ Catheter under fluroscopy

Epidural Catheter; RACZ Catheter

caudal adhesiolysis using NAVI Catheter PROCEDURE

caudal adhesolysis for patients with failed back surgery syndrome using NAVI Catheter under fluroscopy

Epidural Catheter; NAVI catheter

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• previous back surgery of at least 6 months duration.
• age ≥ 18.
• failure of conventional pharmacological management.

You may not qualify if:

• cauda equina syndrome.
• pregnant or lactating women.
• anti-coagulant therapy.

Sponsors & Collaborators

• Assiut University: lead

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Model Details: double-blinded, prospective study

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 22, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share