Caudal Neuroplasty Using Epidural Catheter Combined with Pulsed Radiofrequency (versus Pulsed Radiofrequency Alone

November 27, 2024 updated by: Hossam Elden Owis Shabaan, Assiut University

Safety and Efficacy of Caudal Neuroplasty Using Epidural Catheter Combined with (PRF) Versus (PRF) Alone Both Targeting the Dorsal Root Ganglion in Patients with Lumbosacral Radicular Pain

Evaluating the superiority of caudal neuroplasty using epidural catheter (Perifix® Complete Set 16 G) combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone targeting the dorsal root ganglion In patients with lumbar radicular pain on pain reduction and quality of life within six months follow up.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Lumbosacral radicular pain (LRP) is a frequently encountered symptom, as the annual prevalence in the general population is reported to be from 9.9% to 25% .Acute lumbosacral radiculopathy is a diffuse disease process that affects more than one underlying nerve root, causing pain, loss of sensation, and motor function depending on the severity of nerve compression. Lumbosacral radiculopathy is very common. Most cases of lumbosacral radiculopathy are self-limited. The most common symptom in radiculopathy is paresthesia.Another common presentation is back pain radiating into the foot, with a positive straight leg raising test. Muscle strength is often preserved in the case of radiculopathy because muscles often receive innervation from multiple roots. Thus, muscle strength is often only affected by severe cases of radiculopathy.[2] The most common causes of lumbar radiculopathy are either a herniated disc with resultant nerve root compression or spondylosis. This process can be acute or can develop chronically over time. Imaging is not always a helpful diagnostic modality as almost 27% of patients without back pain have been found to have disc herniation on magnetic resonance imaging (MRI). Furthermore, this incidental finding does not appear to be predictive of future development of back pain. To diagnose a herniated disc as a source of a patient's pain, it is important to review the complete history and physical and making sure that the symptoms match the imaging results. Patients with lumbar radicular pain often respond to conservative management.

Patients who do not respond to conservative therapies will likely need an MRI for further evaluation and characterization of nerve root involvement, epidural steroid injections and other interventional treatments should be considered [3-5] . When all other treatments have failed, surgery should be considered. Epidural fibrosis may cause chronic radicular lower back pain, negatively affecting patients' quality of life. Adhesions in the epidural space may occur due to surgical or non-surgical causes. Non-surgical causes include annular tear, infection, hematoma, and administration of intrathecal contrast material . Scar tissue may develop in the ventral, dorsal, and lateral regions of the epidural space. Dorsal epidural fibrosis may develop due to surgical hematoma absorption, ventral epidural fibrosis may develop due to disc defects, and lateral epidural fibrosis may develop due to disc defects, facet hypertrophy, and lateral foraminal stenosis . In the neural foramen, epidural veins accompany the nerve roots. Epidural scar tissue causes compression of the veins, which gives rise to edema in the epidural area Stand-alone epidural fibrosis is not a cause of pain. Epidural fibrosis-induced scar tissue fixes the nerve root in one position, causing inflammation of the nerve root. Inflammation causes stretching and compression of the nerve root and increased pain during movement [4](13).

Diagnosis of epidural fibrosis is made by physical examination and radiographic methods, including magnetic resonance imaging (MRI), computed tomography (CT), epidurography, and epidural endoscopy. The gold standard diagnostic method is epidural endoscopy .

Epidural neuroplasty, also known as epidural lysis, can be used to treat epidural fibrosis.

Epidural lysis is commonly performed in patients with radiculopathy and nerve root compression caused by epidural scar tissue. The objective of lysis of adhesion areas in neuroplasty is to deliver the drug to the target areas by opening up the scar tissue in order to suppress inflammation Radiofrequency (RF) procedures have been used to provide long term relief for radicular pain . There are two types of RF procedures: ablative and pulsed. Ablative RF (aRF) requires temperatures of 70-80°C and results in neuronal destruction, Pulsed RF (pRF) is usually deployed at temperatures of 40-45°C, thereby avoiding loss of neuronal function but resulting in presumed neuromodulatory effects that contribute to analgesia, The most commonly used sequence for pRF is a pulse frequency of 2 Hz and a pulse width of 20 milliseconds with the treatment delivered over 2-10 min PRF is believed to have a neuromodulator effect rather than a neurorestorative effect which is particularly advantageous during treatment. PRF is a non-neurolytic lesioning technique for pain palliation, and no proof of neural damage has been reported after PRF administration.

Erdine et al. reported that PRF treatment caused microscopic detriment to the internal ultrastructural components of axons, which leads to the deterioration and disorganization of membrane and mitochondrial morphology and microfilaments and microtubules In this study, a trial seeks to find out the safety efficacy and cost-effectiveness of two different nonoperative approaches in patients with lumbosacral radicular pain short- and long-term outcomes as regards its implications on pain reduction ,analgesic consumption, and the patient's quality of life.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hossam Eldin Owis Shaaban, RESIDENT
  • Phone Number: +20 01002482949
  • Email: fivehi535@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients aged 20-80 years old complaining with lumbosacral radicular pain.
  • pain intensity ≥4 out of 10 on the numerical rating scale (NRS).
  • dominant leg pain with less intense back pain.
  • previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications.
  • Epidural injections administered ≥12 weeks prior to recruitment were permitted because most of the patients visiting our clinic had a history of interlaminar or transforaminal epidural injections.
  • Magnetic resonance imaging (MRI) was obtained in all patients and the diagnosis of lumbar disc prolapse was confirmed.

Exclusion Criteria:

  • patient refusal to participate in the study,
  • age <20 years,
  • unbearable pain >9-points on NRS, pain <4-points on NRS.
  • signs of progressive motor weakness or neurologic deficits.
  • Instability of the spine
  • allergies to steroids or contrast dyes.5
  • coagulopathy.
  • steroid injection within the previous 12 weeks.
  • systemic infection, injection site infection.
  • malignancy.
  • unstable medical or psychiatric condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A
Thirty-five patients (to compensate dropouts) will be subjected to Combined caudal neuroplasty using epidural catheter (Perifix® Complete Set 16 G) combined with Pulsed Radiofrequency (PRF) targeting the dorsal root ganglion In patients with lumbosacral radicular pain
Procedure: f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone
Fluoroscopic guidance was used in all cases with a C-arm system. The patient was prone with a pillow under the lower abdomen. Anteroposterior (AP) images were taken to identify the target level. The C-arm was angled 15-30° to project the spinous process over the contralateral facet ("scotty dog" view). Skin was infiltrated with lidocaine, and a 22-gauge RF cannula was advanced under fluoroscopy. The tip was positioned in the dorsal-cranial quadrant of the intervertebral foramen on lateral images. PRF was applied with 4 cycles at 42°C for 8 minutes after sensory/motor testing. Injections of lidocaine and triamcinolone followed. In caudal neuroplasty, an epidural catheter was placed using the sacral hiatus as a guide. Fluoroscopy confirmed catheter position. Contrast was injected to confirm spread, and hyaluronidase and lidocaine were administered. Afterward, the catheter was removed.
Experimental: GROUP B
Thirty-five patients (to compensate dropouts) will be subjected to Pulsed Radiofrequency (PRF) alone targeting the dorsal root ganglion In patients with lumbosacral radicular pain
Procedure: f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone
Fluoroscopic guidance was used in all cases with a C-arm system. The patient was prone with a pillow under the lower abdomen. Anteroposterior (AP) images were taken to identify the target level. The C-arm was angled 15-30° to project the spinous process over the contralateral facet ("scotty dog" view). Skin was infiltrated with lidocaine, and a 22-gauge RF cannula was advanced under fluoroscopy. The tip was positioned in the dorsal-cranial quadrant of the intervertebral foramen on lateral images. PRF was applied with 4 cycles at 42°C for 8 minutes after sensory/motor testing. Injections of lidocaine and triamcinolone followed. In caudal neuroplasty, an epidural catheter was placed using the sacral hiatus as a guide. Fluoroscopy confirmed catheter position. Contrast was injected to confirm spread, and hyaluronidase and lidocaine were administered. Afterward, the catheter was removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in pain intensity using VAS score
Time Frame: baseline
The most effective modality in reducing the intensity of pain in patients with lumbar radicular pain
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of analgesic effect
Time Frame: baseline
Duration of the analgesic effect following RF procedures
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Kilani Ali Abdel-salam, PROF, Assiut University
  • Study Director: Saeid Metwally El Sawy, DR, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2024

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

March 10, 2028

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF vs PRF and neuroplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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