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

NCT03770585 | Completed DMC

• 1 other identifier: 30476/08/15
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Facet Syndrome of Lumbar Spine

Outcome Measures

Primary Outcomes (1)

• Success rate of the technique

  Success rate of the technique

  1 day

Secondary Outcomes (4)

• The visual analogue scale (VAS) score

  Up to 3 months

• Oswestry disability index. (ODI)

  Up to 3 months

• Duration of procedure

  2 hours

• Complications

  1 week

Study Arms (2)

Group 1(Fluoroscopy guided group)

ACTIVE COMPARATOR

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.

Procedure: Fluoroscopy guided Facet joint injection

Group2 (Ultrasound guided group)

ACTIVE COMPARATOR

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.

Procedure: Ultrsound guided Facet joint injection

Interventions

Fluoroscopy guided Facet joint injection PROCEDURE

Fluoroscopy guided Facet joint injection (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.)

Group 1(Fluoroscopy guided group)

Ultrsound guided Facet joint injection PROCEDURE

Ultrsound guided Facet joint injection (Patients will be placed in a prone position. 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 45o with respect to the axial plane)

Group2 (Ultrasound guided group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead
• Tanta University: collaborator

Study Sites (1)

Anesthesia , ICU, and pain medicine department

Tanta, 43636, Egypt

Location

Study Officials

• Marwa Abogabal, MSc.

  Anesthesia, ICU and pain medicine department of Tanta university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2017
• First Posted: December 10, 2018
• Study Start: September 30, 2015
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)