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

NCT05137652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-27

No results posted yet for this study

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

Interventions

DEVICE

Radiofrequency ablation of medial nerve using single needle approach

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.

DEVICE

Radiofrequency ablation of medial nerve using three needle approach

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Hamdy Abbas Youssef, Professor · Professor of anesthesia, intensive care and Pain Relief, Assiut University

  • Abdelraheem Elawamy, Ass. prof. · Associate Professor of anesthesia, intensive care and Pain Relief, Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-08-01
Completion
2024-08-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05137652 on ClinicalTrials.gov