Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

NCT ID: NCT06051149

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2026-01-31

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.

Conditions

Failed Back Surgery Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Epidural Catheter

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.

Group Type: ACTIVE_COMPARATOR

caudal adhesolysis using RACZ Catheter

Intervention Type: PROCEDURE

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

caudal adhesiolysis using NAVI Catheter

Intervention Type: PROCEDURE

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

RACZ Catheter

same as procedure described above but using RACZ Catheter set

Group Type: ACTIVE_COMPARATOR

caudal adhesolysis using RACZ Catheter

Intervention Type: PROCEDURE

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

NAVI catheter

same as procedure described above but using NAVI Catheter set

Group Type: ACTIVE_COMPARATOR

caudal adhesiolysis using NAVI Catheter

Intervention Type: PROCEDURE

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

Interventions

caudal adhesolysis using RACZ Catheter

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

Intervention Type: PROCEDURE

caudal adhesiolysis using NAVI Catheter

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Abul-Fotouh Mohamed

principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AUN1615

Identifier Type: -

Identifier Source: org_study_id