Comparative Evaluation of the Results of Facet Joint Injections

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325631
• Other study ID #: Ankara City Hospital Bilkent
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with facet joint syndrome diagnosis

Exclusion Criteria:

• pregnant patients

• breastfeeding patients

• patients with cardiac pacemaker

Related Conditions & MeSH terms

• Back Pain
• Facet Syndrome of Lumbar Spine
• Low Back Pain
• Low Back Pain, Mechanical
• Syndrome

Intervention

Procedure:
• Intra-articular injection to lumbar facet joint
to treat low back pain caused by facet joint syndrome

Locations

Country	Name	City	State
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Oznur Uzun

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 F — View Citation

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. — View Citation

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: 10.71 — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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