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

Primary Purpose

Lumbar Facet Joint Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Radiofrequency ablation of medial nerve using single needle approach
Radiofrequency ablation of medial nerve using three needle approach
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Facet Joint Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age group of 18-60 yrs who are complaining of low back pain due to lumbar facet joint arthritis.

Exclusion Criteria:

  • Patient or relative in charge refusal.

Sites / Locations

  • Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Study group

Arm Description

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

40 patients will receive the three needle approach.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Decrease the rate of recurrence of low back pain due to facet arthritis
regarding low back pain of lumbar facet arthritis, the secondary outcome is to decrease the rate of recurrence, the need of prolonged periods of adjuvant pharmacological treatment, the need of future surgical intervention or even the need of further sessions of radiofrequency ablation.

Full Information

First Posted
September 18, 2021
Last Updated
October 11, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05137652
Brief Title
One-Needle Vs Three-Needle Radiofrequency in Low Back Pain Due to Facet Joint Arthritis
Official Title
Comparison Between One-Needle Vs Three-Needle Technique for Lumbar Radiofrequency Medial Branch Denervation in Pain Management of Low Back Pain Due to Facet Joint Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Low back pain (LBP) is more accurately called lumbago or lumbosacral pain, which is defined as discomfort, tension, or stiffness below the costal margin and above the inferior gluteal folds. In Egypt, patients with LBP constituted a high percentage of patients seeking medical care at outpatient's clinics reaching about 48% making it one of the most common causes of disability in the working population. no large-scale retrospective studies have investigated long-term clinical predictors of success in individuals receiving radiofrequency ablation (RFA) of the medial branches for facet joint arthropathy. Employees who are unable to work due to back pain spend a significant amount of time on sick leave, which impacts the productivity in the work place. Risk factors for LBP are multifactorial, including exercise, obesity, smoking, age, and sex, and these can be grouped together as individual fa pctors. Low back pain can arise from multiple anatomic locations: the intervertebral discs that are positioned between the vertebral bodies of the spine, the facet joint, but also non bony structures such as the paravertebral muscles, ligaments, and fascia. Postmortem studies have revealed that intervertebral discs and facet joints exhibit the greatest degree of degeneration within the spine, thus indicating the potential role of these structures in causing low back pain. In patients with a structural cause of low back pain, up to 40% of cases likely arise from the lumbar facet joints. The etiology of lumbar facet-joint pain is thought to be stress and trauma to the joint, which subsequently leads to inflammation of the joint capsule. Treatment options for facet arthropathy range from conservative management with medications and physical therapy to interventional management, including facet-joint injections and radiofrequency ablation (RFA) of the medial branches of the posterior rami to the facet joints. RFA of the medial branches of the dorsal rami is thought to be the most effective interventional treatment for facet joint pain and has been reported to relieve pain for 6 months to 1 year in 60% of patients. Although providing benefit in a significant proportion of patients, there remains a group of patients who do not experience any pain relief from RFA or experience only benefit from the ablation for a short period. 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. The aim of this technical note is to detail a two-needle approach to lumbar medial branch RF denervation to maximize lesion size along the course of the medial branch nerve. VAS scores were based on self-reported measures of lumbar back pain and were recorded as a continuum between 2 ends of a scale, with "no pain" corresponding to the left end of the scale (0 cm) and "worst pain" corresponding to the right end of the scale (10 cm). The VAS is a validated, subjective tool to measure both acute and chronic pain. Pre-procedural VAS pain scores were documented prior to the lumbar RFA procedure (pre-VAS) and during the following time points after lumbar medial branch RFA was performed: short-term (1-week to 1-month), 3-month, 6-month, and 1-year visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Facet Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
single needle approach for 40 patients in which nerve is traditionally been targeted.
Arm Title
Study group
Arm Type
Experimental
Arm Description
40 patients will receive the three needle approach.
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation of medial nerve using single needle approach
Other Intervention Name(s)
Control group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation of medial nerve using three needle approach
Other Intervention Name(s)
Study group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in VAS pain score.
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Decrease the rate of recurrence of low back pain due to facet arthritis
Description
regarding low back pain of lumbar facet arthritis, the secondary outcome is to decrease the rate of recurrence, the need of prolonged periods of adjuvant pharmacological treatment, the need of future surgical intervention or even the need of further sessions of radiofrequency ablation.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group of 18-60 yrs who are complaining of low back pain due to lumbar facet joint arthritis. Exclusion Criteria: Patient or relative in charge refusal.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Hashem Sleem, Ass. Lec.
Phone
+201002954939
Email
ahmad_hs_87@med.aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amani Hassan Abdel Wahab, Ass. prof.
Phone
+201004610623
Email
amanihassan1976@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamdy Abbas Youssef, Professor
Organizational Affiliation
Professor of anesthesia, intensive care and Pain Relief, Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdelraheem Elawamy, Ass. prof.
Organizational Affiliation
Associate Professor of anesthesia, intensive care and Pain Relief, Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University
City
Asyūţ
State/Province
Asyut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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