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Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis in Failed Back Surgery Syndrome.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06051149
Enrollment
78
Registered
2023-09-22
Start date
2024-01-31
Completion date
2026-01-31
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Back Surgery Syndrome

Keywords

caudal adhesiolysis, catheter type

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.

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes 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.

Intervention model description

double-blinded, prospective study

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pain score6 months after intervention-difference in numeric rating scale at 6 months after intervention, minmal value 0 and maximum value 100 which is worst(more pain intensity)

Secondary

MeasureTime frameDescription
functional outcome6 months after interventionThe Oswestry Disability Index,minmal value 0 and maximum value 50 which is worst(complete disability)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026