Effect of Pulsed Mode Radiofrequency as a Treatment of Lumbar Disc Related Radicular Pain on Tumor Necrotic Factor α Level

NCT05288920 | Completed Phase 1 DMC

• 1 other identifier: FMBSUREC/06042021/Fathy-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Lumbar radiculopathy is a term that describes symptoms of pain, numbness, and/or weakness that radiate along the sciatic nerve from the lower back to the buttocks and leg (1). Lumbar radiculopathy is a relevant health problem that affects quality of life, resulting in high health costs and economic loss worldwide (2). The reported prevalence of sciatica varies widely from 1.2% and 43% in the general population (3). Although initially believed to be a primary mechanical insult to the nerve root and dorsal root ganglion, lumbar radiculopathy is possibly caused by inflammatory changes in the nerve root (4). The role of cytokine-mediated neuroimmune interactions in the development and persistence of pain has been extensively studied (5,6,7). Intraneural application of pro-inflammatory cytokines induces behavioral signs associated with pain (8). Anti-inflammatory cytokine treatment effectively reduces hyperalgesia (9). Inflammatory cytokine inhibitors provided long-lasting analgesia in an inflammatory neuropathic pain model. On the basis of these findings, we evaluated whether cytokine profiles differ between severe and mild human sciatica, as well as whether distinct cytokine profiles provide relevant information regarding lumbar radiculopathy pathogenesis. (10,11). Tumor necrosis factor-alpha (TNF-α) is a pleiotropic cytokine that can stimulate inflammatory responses of synapses and myelin sheath, promote cellular apoptosis because of its cytotoxic effect, and induce nerve swelling and neuropathic pain (12). TNF-α influences neural survival, exerting both neuroprotective and neurodegenerative actions (13). Following peripheral nerve injury, upregulation of TNF-α expression has been documented in several neuropathic pain models (14). Pulsed radiofrequency (PRF) is a relatively new developed technique that is a variation of conventional radiofrequency treatment. PRF treatment does not allow temperatures above 42°C at the tip of the electrode. PRF provides advantage avoiding thermal tissue destruction and pain sequelae in management of pain. Recently, it has been recommended for treatment of chronic pain (15). Electromagnetic field which is thought to be responsible for the clinical effect of pulsed RF spread from active tip of electrode to around the electrode. The most intense part of the electromagnetic field is pointed tip of the electrode (16). It is a minimally invasive technique that involves application of electric fields to nerves to inhibit nociceptive stimuli and prevent pain transmission. PRF can be considered when conventional treatments have intolerable side effects or do not sufficiently relieve pain (17). Working mechanism of PRF which is recently more preferred technique to treat chronic pain due to not forming tissue damage and less painful procedure is not exactly known but it is considered to act neuromodulation (18). The aim of this work is to compare the effect of transforaminal injection of Steroids alone versus Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection on TNF-α level in lumbar disc related radicular pain

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (3)

• Modified Oswestry Back Disability Score

  Functional disability

  3 months

• Numeric Rating Scale

  Pain intensity

  3 months

• The Short Assessment of Patient Satisfaction

  Patient's satisfaction

  3 months

Study Arms (2)

Radiofrequency group

ACTIVE COMPARATOR

Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection

Procedure: Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection

Steroids group

PLACEBO COMPARATOR

Transforaminal injection of Steroids alone

Drug: Transforaminal injection of Steroids alone

Interventions

Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection PROCEDURE

Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection

Radiofrequency group

Transforaminal injection of Steroids alone DRUG

Transforaminal injection of Steroids alone

Steroids group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as having symptomatic lumbar disc prolapse based on the following:
• Clinical evidence of disc pulge in the form of disc related radicular pain of \>3 months duration, not responding to conservative treatment and interfering with daily activities
• Radiological demonstration of posterolateral lumbar disc pulge by MRI lumbosacral
• Age range is between 30-80 years

You may not qualify if:

• Patients with spinal deformities
• Patients with a previous history of spinal trauma
• Patients with previous spinal surgery
• Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the spinal cord or vertebral column
• Patients with severe lumbar disc herniation causing lower limb weakness or sphincteric troubles
• Patient with pain rather than radicular neuropathic pain as Facet osteoarthritis, Sacroiliitis, Hip osteoarthritis, Discogenic, Pyriformis syndrome.
• Patients with contraindications to interventions (coagulopathy, sepsis, or allergy to the used drugs)
• Patients with contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body).
• Pregnant
• History of G6PD deficiency in patients who are candidates to receive ozone therapy.
• Suspected spondylodiscitis.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Mona Hussein

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Beni-Suef University

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Neurology

Model Details: To compare the effect of transforaminal injection of Steroids alone versus Radiofrequency pulsed mode on dorsal root ganglion combined with transforaminal steroids injection on TNF-α level in lumbar disc related radicular pain

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)