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Failed Back Surgery SyndromeNCT06051149

Effect of Catheter Type on Efficacy of Percutaneous Caudal Adhesolysis

A study testing caudal adhesolysis using RACZ Catheter and caudal adhesiolysis using NAVI Catheter in people with Failed Back Surgery Syndrome, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Failed Back Surgery Syndrome
What is being tested?
caudal adhesolysis using RACZ Catheter and caudal adhesiolysis using NAVI Catheter
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
No sites listed yet
Study dates
Jan 2024to Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Being tested
caudal adhesolysis using RACZ Catheter, caudal adhesiolysis using NAVI Catheter
Keywords
caudal adhesiolysis, catheter type
Medical subject headings
Failed Back Surgery Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • caudal adhesolysis using RACZ CatheterProcedure or surgery

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

  • caudal adhesiolysis using NAVI CatheterProcedure or surgery

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

Study groups in NCT06051149
Study groupRoleWhat they receive
Epidural CatheterActive comparatorprocedure 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.
Receives: Procedure: caudal adhesolysis using RACZ Catheter; Procedure: caudal adhesiolysis using NAVI Catheter
RACZ CatheterActive comparatorsame as procedure described above but using RACZ Catheter set
Receives: Procedure: caudal adhesolysis using RACZ Catheter
NAVI catheterActive comparatorsame as procedure described above but using NAVI Catheter set
Receives: Procedure: caudal adhesiolysis using NAVI Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 months after intervention

Secondary outcomes (1)
  1. functional outcome

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

    Measured: 6 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double-blinded, prospective study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06051149
Sponsor's protocol ID
AUN1615
Status last verified
Sep 2023
First submitted
17 Sep 2023
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing caudal adhesolysis using RACZ Catheter and caudal adhesiolysis using NAVI Catheter in people with Failed Back Surgery Syndrome, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.

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