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

Primary Purpose

Facet Syndrome of Lumbar Spine

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fluoroscopy guided Facet joint injection
Ultrsound guided Facet joint injection
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Facet Syndrome of Lumbar Spine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Sites / Locations

  • Anesthesia , ICU, and pain medicine department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1(Fluoroscopy guided group)

Group2 (Ultrasound guided group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Success rate of the technique
Success rate of the technique

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2017
Last Updated
December 7, 2018
Sponsor
Mansoura University
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT03770585
Brief Title
Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome
Official Title
Comparative Study Between Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2015 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
Collaborators
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facet Syndrome of Lumbar Spine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1(Fluoroscopy guided group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group2 (Ultrasound guided group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fluoroscopy guided Facet joint injection
Intervention Description
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.)
Intervention Type
Procedure
Intervention Name(s)
Ultrsound guided Facet joint injection
Intervention Description
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)
Primary Outcome Measure Information:
Title
Success rate of the technique
Description
Success rate of the technique
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The visual analogue scale (VAS) score
Description
The visual analogue scale (VAS) score: before injections and at 1hour,a week, a month, and three months after injections.
Time Frame
Up to 3 months
Title
Oswestry disability index. (ODI)
Description
(Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life and Traveling )
Time Frame
Up to 3 months
Title
Duration of procedure
Description
Duration of procedure
Time Frame
2 hours
Title
Complications
Description
Allergy, infection
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Abogabal, MSc.
Organizational Affiliation
Anesthesia, ICU and pain medicine department of Tanta university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesia , ICU, and pain medicine department
City
Tanta
ZIP/Postal Code
43636
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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