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

NCT06711419 | Not Yet Recruiting DMC

• 1 other identifier: PRF vs PRF and neuroplasty
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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 follow up.

Conditions

Disc Herniation

Keywords

Pulsed radio freqency; caudal neuroplasty

Outcome Measures

Primary Outcomes (1)

• improvement in pain intensity using VAS score

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

  baseline

Secondary Outcomes (1)

• duration of analgesic effect

  baseline

Study Arms (2)

GROUP A

EXPERIMENTAL

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

GROUP B

EXPERIMENTAL

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

Interventions

f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone PROCEDURE

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.

GROUP A; GROUP B

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

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  PMID: 12508296 BACKGROUND

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

  PMID: 422980 BACKGROUND

• 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.

  PMID: 20166095 BACKGROUND

• 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.

  PMID: 8208267 BACKGROUND

• 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.

  PMID: 2312537 BACKGROUND

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

  PMID: 34318919 BACKGROUND

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

  PMID: 25395115 BACKGROUND

• 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.

  PMID: 33471393 BACKGROUND

• 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.

  PMID: 21812907 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Prolactin-Releasing Hormone; Single Person

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Kilani Ali Abdel-salam, PROF

  Assiut University

  STUDY CHAIR

• Saeid Metwally El Sawy, DR

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Hossam Eldin Owis Shaaban, RESIDENT

CONTACT

01002482949; fivehi535@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 2, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): March 10, 2028
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share