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Lumbar Facet Joint PainNCT05137652

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

A study testing Radiofrequency ablation of medial nerve using single needle approach and Radiofrequency ablation of medial nerve using three needle approach in people with Lumbar Facet Joint Pain, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Lumbar Facet Joint Pain
What is being tested?
Radiofrequency ablation of medial nerve using single needle approach and Radiofrequency ablation of medial nerve using three needle approach
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Mar 2022to 25 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University

    Asyut, Asyut Governorate, 71111

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
Radiofrequency ablation of medial nerve using single needle approach, Radiofrequency ablation of medial nerve using three needle approach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency ablation of medial nerve using single needle approachDevice

    Also called Control group

    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.

  • Radiofrequency ablation of medial nerve using three needle approachDevice

    Also called Study group

    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.

Study groups in NCT05137652
Study groupRoleWhat they receive
Control groupOthersingle needle approach for 40 patients in which nerve is traditionally been targeted.
Receives: Device: Radiofrequency ablation of medial nerve using single needle approach
Study groupExperimental40 patients will receive the three needle approach.
Receives: Device: Radiofrequency ablation of medial nerve using three needle approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (1)
  1. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2021
  2. Study start1 Mar 2022
  3. Primary completion1 Aug 2024
  4. Study completion25 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05137652
Sponsor's protocol ID
IRB:17200664
Status last verified
Aug 2024
First submitted
18 Sep 2021
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation of medial nerve using single needle approach and Radiofrequency ablation of medial nerve using three needle approach in people with Lumbar Facet Joint Pain, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in VAS pain score. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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