Comparative Evaluation of the Results of Facet Joint Injections

Comparative Evaluation of the Results of Facet Joint Injections Performed by Using Fluoroscopy, Ultrasound Guidance and Anatomic Location Administered to the Patients With Facet Syndrome

Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain, Mechanical; Facet Syndrome of Lumbar Spine
• Intervention / Treatment: Procedure: Intra-articular injection to lumbar facet joint

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Ankara Bilkent Sehir Hastanesi
    • Contact: Öznur UZUN, MD; Phone Number: +905052912734; Email: soznuruzuns@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with facet joint syndrome diagnosis

Exclusion Criteria:

• pregnant patients
• breastfeeding patients
• patients with cardiac pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound	Procedure: Intra-articular injection to lumbar facet joint; to treat low back pain caused by facet joint syndrome
Experimental: Fluoroscopy	Procedure: Intra-articular injection to lumbar facet joint; to treat low back pain caused by facet joint syndrome
Experimental: Anatomic	Procedure: Intra-articular injection to lumbar facet joint; to treat low back pain caused by facet joint syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Pain intensity will be measured with Visual Analogue Scale, which is used to measure musculoskeletal pain with very good reliability and validity. Visual Analogue Scale is between 0-10 cm. 0 means no pain, 10 means the most severe pain.	VAS will be applied to the patients before the procedure and at the first and twelfth week after the procedure

Collaborators and Investigators

• Sponsor: Oznur Uzun

Publications and helpful links

General Publications

• Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010 May 28;7(3):124-35. doi: 10.7150/ijms.7.124.
• Gomez Vega JC, Acevedo-Gonzalez JC. Clinical diagnosis scale for pain lumbar of facet origin: systematic review of literature and pilot study. Neurocirugia (Astur : Engl Ed). 2019 May-Jun;30(3):133-143. doi: 10.1016/j.neucir.2018.05.004. Epub 2018 Jun 14. English, Spanish.
• Nelson AM, Nagpal G. Interventional Approaches to Low Back Pain. Clin Spine Surg. 2018 Jun;31(5):188-196. doi: 10.1097/BSD.0000000000000542.
• Baroncini A, Maffulli N, Eschweiler J, Knobe M, Tingart M, Migliorini F. Management of facet joints osteoarthritis associated with chronic low back pain: A systematic review. Surgeon. 2021 Dec;19(6):e512-e518. doi: 10.1016/j.surge.2020.12.004. Epub 2021 Feb 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: low back pain; ultrasound; fluoroscopy; facet joint syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Back Pain; Low Back Pain
• Other Study ID Numbers: Ankara City Hospital Bilkent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No