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Disc HerniationNCT06711419

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

A study testing f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone in people with Disc Herniation, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Disc Herniation
What is being tested?
f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
10 Dec 2024to 10 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • coagulopathy.
  • steroid injection within the previous 12 weeks.
  • systemic infection, injection site infection.
  • malignancy.
  • unstable medical or psychiatric condition

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hossam Eldin Owis Shaaban, RESIDENT contact

01002482949 ext. +20

fivehi535@gmail.com

About this study

Official title: 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.

Read the 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.

Conditions
Disc Herniation
Being tested
f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone
Keywords
Pulsed radio freqency, caudal neuroplasty
Medical subject headings
Intervertebral Disc Displacement

What participants receive

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

  • f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) aloneProcedure or surgery

    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.

Study groups in NCT06711419
Study groupRoleWhat they receive
GROUP AExperimentalThirty-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
Receives: Procedure: f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone
GROUP BExperimentalThirty-five patients (to compensate dropouts) will be subjected to Pulsed Radiofrequency (PRF) alone targeting the dorsal root ganglion In patients with lumbosacral radicular pain
Receives: Procedure: f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone

What is being measured

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

  1. improvement in pain intensity using VAS score

    The most effective modality in reducing the intensity of pain in patients with lumbar radicular pain

    Measured: baseline

Secondary outcomes (1)
  1. duration of analgesic effect

    Duration of the analgesic effect following RF procedures

    Measured: baseline

Timeline

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

  1. First posted2 Dec 2024
  2. Study start10 Dec 2024 (estimated)
  3. Primary completion10 Sep 2027 (estimated)
  4. Study completion10 Mar 2028 (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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06711419
Sponsor's protocol ID
PRF vs PRF and neuroplasty
Status last verified
Nov 2024
First submitted
22 Nov 2024
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsao BE, Levin KH, Bodner RA. Comparison of surgical and electrodiagnostic findings in single root lumbosacral radiculopathies. Muscle Nerve. 2003 Jan;27(1):60-4. doi: 10.1002/mus.10291.

    PubMed 12508296
  • Weir BK. Prospective study of 100 lumbosacral discectomies. J Neurosurg. 1979 Mar;50(3):283-9. doi: 10.3171/jns.1979.50.3.0283.

    PubMed 422980
  • van der Windt DA, Simons E, Riphagen II, Ammendolia C, Verhagen AP, Laslett M, Deville W, Deyo RA, Bouter LM, de Vet HC, Aertgeerts B. Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007431. doi: 10.1002/14651858.CD007431.pub2.

    PubMed 20166095
  • Jensen MC, Brant-Zawadzki MN, Obuchowski N, Modic MT, Malkasian D, Ross JS. Magnetic resonance imaging of the lumbar spine in people without back pain. N Engl J Med. 1994 Jul 14;331(2):69-73. doi: 10.1056/NEJM199407143310201.

    PubMed 8208267
  • Boden SD, Davis DO, Dina TS, Patronas NJ, Wiesel SW. Abnormal magnetic-resonance scans of the lumbar spine in asymptomatic subjects. A prospective investigation. J Bone Joint Surg Am. 1990 Mar;72(3):403-8.

    PubMed 2312537
  • Yildirim HU, Akbas M. Percutaneous and Endoscopic Adhesiolysis. Agri. 2021 Jul;33(3):129-141. doi: 10.14744/agri.2020.70037.

    PubMed 34318919
  • Veizi E, Hayek S. Interventional therapies for chronic low back pain. Neuromodulation. 2014 Oct;17 Suppl 2:31-45. doi: 10.1111/ner.12250.

    PubMed 25395115
  • Pushparaj H, Hoydonckx Y, Mittal N, Peng P, Cohen SP, Cao X, Bhatia A. A systematic review and meta-analysis of radiofrequency procedures on innervation to the shoulder joint for relieving chronic pain. Eur J Pain. 2021 May;25(5):986-1011. doi: 10.1002/ejp.1735. Epub 2021 Feb 6.

    PubMed 33471393
  • Van Boxem K, van Bilsen J, de Meij N, Herrler A, Kessels F, Van Zundert J, van Kleef M. Pulsed radiofrequency treatment adjacent to the lumbar dorsal root ganglion for the management of lumbosacral radicular syndrome: a clinical audit. Pain Med. 2011 Sep;12(9):1322-30. doi: 10.1111/j.1526-4637.2011.01202.x. Epub 2011 Aug 3.

    PubMed 21812907

Questions about this trial

What is this clinical trial studying?

A study testing f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone in people with Disc Herniation, 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 2 Dec 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Hossam Eldin Owis Shaaban, RESIDENT (01002482949 ext. +20, fivehi535@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

improvement in pain intensity using VAS score (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06711419, which also lists 9 linked publications.

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 2 Dec 2024.

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