Comparative Evaluation of the Results of Facet Joint Injections

NCT ID: NCT06325631

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fluoroscopy

Group Type: EXPERIMENTAL

Intra-articular injection to lumbar facet joint

Intervention Type: PROCEDURE

to treat low back pain caused by facet joint syndrome

Ultrasound

Group Type: EXPERIMENTAL

Intra-articular injection to lumbar facet joint

Intervention Type: PROCEDURE

to treat low back pain caused by facet joint syndrome

Anatomic

Group Type: EXPERIMENTAL

Intra-articular injection to lumbar facet joint

Intervention Type: PROCEDURE

to treat low back pain caused by facet joint syndrome

Interventions

Intra-articular injection to lumbar facet joint

to treat low back pain caused by facet joint syndrome

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with facet joint syndrome diagnosis

Exclusion Criteria

• pregnant patients
• breastfeeding patients
• patients with cardiac pacemaker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oznur Uzun

OTHER

Sponsor Role: lead

Responsible Party

Oznur Uzun

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ankara Bilkent Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 29910103 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20567613 (View on PubMed)

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

Reference Type: RESULT

PMID: 28486278 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33582054 (View on PubMed)

Other Identifiers

Ankara City Hospital Bilkent

Identifier Type: -

Identifier Source: org_study_id