One-Needle Vs Three-Needle Radiofrequency in Low Back Pain Due to Facet Joint Arthritis

NCT05137652 | Completed

• 1 other identifier: IRB:17200664
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Failure of RFA has been attributed to technical failure of coagulating the nerve or coagulation of a minimal section of the nerve, allowing for early reinnervation. Consequently, increasing the success rate and duration of relief may require techniques that increase the likelihood of successful nerve ablation over a relevant distance by maximizing lesion size.

Conditions

Lumbar Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

• Improvement in VAS pain score.

  Responder status was defined as a 30% or greater improvement in pain Visual Analogue Score from the pre-procedural pain VAS score. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult diseases including low back pain. The pain VAS originated from continuous visual analog scales developed in the field of psychology to measure well-being. the first reported use of the VAS pain scale was with the descriptor extremes "no pain at all" and "my pain is as bad as it could possibly be" in patients with a variety of conditions.

  24 months

Secondary Outcomes (1)

• Decrease the rate of recurrence of low back pain due to facet arthritis

  24 months

Study Arms (2)

Control group

OTHER

single needle approach for 40 patients in which nerve is traditionally been targeted.

Device: Radiofrequency ablation of medial nerve using single needle approach

Study group

EXPERIMENTAL

40 patients will receive the three needle approach.

Device: Radiofrequency ablation of medial nerve using three needle approach

Interventions

Radiofrequency ablation of medial nerve using single needle approach DEVICE

The primary outcome is to study the efficacy of the described technique which creates a lesion that we estimate to be 11.0-mm wide and 11.6-mm long along the course of the medial branch adjacent to the SAP ensuring adequate coverage and treatment using VAS score. Responder status was defined as a 30% or greater improvement in VAS pain score from the pre-procedural VAS pain score. Outcomes were summarized by means and standard deviations for continuous outcomes, and frequencies (%) for categorical outcomes.

Also known as: Control group

Control group

Radiofrequency ablation of medial nerve using three needle approach DEVICE

The primary outcome is to study the efficacy of the described technique by maximizing the lesion size (compared to control group) along the course of the medial branch adjacent to the SAP ensuring adequate coverage and treatment using VAS score.

Also known as: Study group

Study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group of 18-60 yrs who are complaining of chronic lower back pain due to lumbar facet joint arthritis not responded to medical treatment for more than 6 months.
• Failed back surgery syndrome without instrumentation.

You may not qualify if:

• Patient or relative in charge refusal.
• Associated lumbar disc prolapse.
• Negative diagnostic test.
• Contraindication for radiological exposure as pregnancy and osteoporosis.
• Inability to lie in a prone position.
• Failed back surgery syndrome with previous instrumentation insertion
• Contraindications for regional techniques

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71111, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hamdy Abbas Youssef, Professor

  Professor of anesthesia, intensive care and Pain Relief, Assiut University

  STUDY DIRECTOR

• Abdelraheem Elawamy, Ass. prof.

  Associate Professor of anesthesia, intensive care and Pain Relief, Assiut University

  STUDY DIRECTOR

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: Professor of anesthesia, ICU and pain management

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: November 30, 2021
• Study Start: March 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 25, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)