Comparative Evaluation of the Results of Facet Joint Injections

NCT06325631 | Completed

• 1 other identifier: Ankara City Hospital Bilkent
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain, Mechanical; Facet Syndrome of Lumbar Spine

Keywords

facet joint syndrome; low back pain; fluoroscopy; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Fluoroscopy

EXPERIMENTAL

Procedure: Intra-articular injection to lumbar facet joint

Ultrasound

EXPERIMENTAL

Procedure: Intra-articular injection to lumbar facet joint

Anatomic

EXPERIMENTAL

Procedure: Intra-articular injection to lumbar facet joint

Interventions

Intra-articular injection to lumbar facet joint PROCEDURE

to treat low back pain caused by facet joint syndrome

Anatomic; Fluoroscopy; Ultrasound

Eligibility Criteria

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

You may qualify if:

• Patients with facet joint syndrome diagnosis

You may not qualify if:

• pregnant patients
• breastfeeding patients
• patients with cardiac pacemaker

Sponsors & Collaborators

• Oznur Uzun: lead

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• Gomez Vega JC, Acevedo-Gonzalez JC. Clinical diagnosis scale for pain lumbar of facet origin: systematic review of literature and pilot study. Neurocirugia (Engl Ed). 2019 May-Jun;30(3):133-143. doi: 10.1016/j.neucir.2018.05.004. Epub 2018 Jun 14. English, Spanish.

  PMID: 29910103 RESULT

• 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.

  PMID: 20567613 RESULT

• Nelson AM, Nagpal G. Interventional Approaches to Low Back Pain. Clin Spine Surg. 2018 Jun;31(5):188-196. doi: 10.1097/BSD.0000000000000542.

  PMID: 28486278 RESULT

• 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.

  PMID: 33582054 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 22, 2024
• Study Start: January 2, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)