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Not yet recruitingNCT06051149Updated Oct 3, 2023

Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

An interventional study of caudal adhesolysis using RACZ Catheter and caudal adhesiolysis using NAVI Catheter in Failed Back Surgery Syndrome, sponsored by Assiut University. Not yet recruiting. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Failed Back Surgery Syndrome

Keywords

  • caudal adhesiolysis
  • catheter type
03

In context

Syndrome

9,215 studies on the registry are indexed under Syndrome; 1,029 are open to participants now.

This study's planned enrollment of 78 is above the median of 50 across 6,513 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • cauda equina syndrome.
  • pregnant or lactating women.
  • anti-coagulant therapy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Active comparator
    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.

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

  • Active comparator
    RACZ Catheter

    same as procedure described above but using RACZ Catheter set

    Procedure: caudal adhesolysis using RACZ Catheter

  • Active comparator
    NAVI catheter

    same as procedure described above but using NAVI Catheter set

    Procedure: caudal adhesiolysis using NAVI Catheter

Interventions

  • Procedurecaudal adhesolysis using RACZ Catheter

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

  • Procedurecaudal adhesiolysis using NAVI Catheter

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

06

What researchers measure

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)

    Time frame: 6 months after intervention

Secondary outcomes

  1. functional outcome

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

    Time frame: 6 months after intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06051149
Lead sponsor
Assiut University
Responsible party
Mostafa Abul-Fotouh Mohamed (principal Investigator, Assiut University) — Principal investigator
First posted
Sep 22, 2023
Start date
Jan 2024 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Jan 2026 (estimated)
Last update
Oct 3, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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