Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome

Not Applicable

Completed

• Conditions: Facet Syndrome of Lumbar Spine
• Interventions: Procedure: Fluoroscopy guided Facet joint injection; Procedure: Ultrsound guided Facet joint injection

• Registration Number: NCT03770585
• Lead Sponsor: Mansoura University

Brief Summary

The aim of this study is to compare the efficacy of fluoroscopy guided lumbar facet joint injection versus ultrasound guided injection in patients with low back pain due to facet syndrome.

Detailed Description

All patients will be randomly classified into two equal groups (40 patients each) by using closed envelops, a computer generated random allocation codes.

Group 1(Fluoroscopy guided group) (n =40 patients):

The patient will be placed in the prone position with a pillow under the abdomen to correct the lumbar lordosis. The joint to be injected is located and marked, the x ray tube is then slowly rotated till the joint appear in profile as two parallel lines. After cleaning and drapping and administration of local anesthesia a22-g spinal needle is inserted in line with x-ray beam till bony contact is felt. All procedures will be performed under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.

Group2 (Ultrasound guided group) (n=40 patients):

Patients will be placed in a prone position. Posterior paravertebral parasagittal sonograms will be obtained to identify of the different spinal levels. The spinous process and adjacent structures (lamina of the vertebral arch, facet joint, accessory process, and mammillary process) will be delineated by transverse sonograms at the target level, and the midpoint of the facet joint space will be established. After cleaning and drapping and administration of local anesthesia. If the joint is clearly or partially visible, a spinal needle is advanced under US guidance into the joint space of each lumbar facet joint. The needle is inserted 1-2 cm laterally from the midline at the lateral end of the transducer and precisely positioned in the US plane at an angle of approximately 45owith respect to the axial plane until the needle tip reached the target and bony contact is felt. This enables visualization of the needle, which appears as a bright line-shaped echo pattern on the transverse sonogram. If the needle placement is correct, a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml(20mg) methylprednisolone acetate is administered intra-articular (until resistance was encountered) and injected around the posterior facet joint capsule.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-09-30
• Study First Submitted: 2017-03-25
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-07
• Last Update Submitted: 2018-12-07
• Study First Posted: 2018-12-10
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients, more than 18 years old, with pain associated with lumbar hyper-extension, lateral flexion, and tenderness on paravertebral regions corresponding to facet joints but normal findings on the straight leg raise test and neurologic examination.

Read More

Exclusion Criteria

• Patient refusal and lack of consent.
• Local or systemic infection.
• allergy to steroids or local anesthetics
• Patients with coagulopathies.
• Evidence of nerve root compression at the expected level on MRI.
• Pregnant patients

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1(Fluoroscopy guided group)	Fluoroscopy guided Facet joint injection	IN Fluoroscopy guided group, with x-ray beam, after cleaning and drapping and administration of local anesthesia, a22-g spinal needle is inserted in line till bony contact is felt under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.
Group2 (Ultrasound guided group)	Ultrsound guided Facet joint injection	In Ultrasound guided group, with Ultrasound guidance, , a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml(20mg) methylprednisolone acetate is administered intra-articular (until resistance was encountered) and injected around the posterior facet joint capsule.

Primary Outcome Measures

Name	Time	Method
Success rate of the technique	1 day	Success rate of the technique

Secondary Outcome Measures

Name	Time	Method
Duration of procedure	2 hours	Duration of procedure
The visual analogue scale (VAS) score	Up to 3 months	The visual analogue scale (VAS) score: before injections and at 1hour,a week, a month, and three months after injections.
Oswestry disability index. (ODI)	Up to 3 months	(Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life and Traveling )
Complications	1 week	Allergy, infection

Trial Locations

Locations (1)

Anesthesia , ICU, and pain medicine department; 🇪🇬 Tanta, Egypt