Facet Syndrome of Lumbar SpineNCT03770585
Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome
A study testing Fluoroscopy guided Facet joint injection and Ultrsound guided Facet joint injection in people with Facet Syndrome of Lumbar Spine, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet Syndrome of Lumbar Spine
- What is being tested?
- Fluoroscopy guided Facet joint injection and Ultrsound guided Facet joint injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2015to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Facet Syndrome of Lumbar Spine
- Being tested
- Fluoroscopy guided Facet joint injection, Ultrsound guided Facet joint injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopy guided Facet joint injectionProcedure or surgery
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.)
Ultrsound guided Facet joint injectionProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Ultrsound guided Facet joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the technique
Success rate of the technique
Measured: 1 day
Secondary outcomes (4)
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.
Measured: Up to 3 months
Oswestry disability index. (ODI)
(Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life and Traveling )
Measured: Up to 3 months
Duration of procedure
Duration of procedure
Measured: 2 hours
Complications
Allergy, infection
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start30 Sep 2015
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Syndrome of Lumbar SpineStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor
- Investigators
- Marwa Abogabal, MSc., Principal investigator, Anesthesia, ICU and pain medicine department of Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770585
- Sponsor's protocol ID
- 30476/08/15
- Status last verified
- Dec 2018
- First submitted
- 25 Mar 2017
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03770585
- Acronym / sponsor ID
- 30476/08/15
- Conditions
- Facet Syndrome of Lumbar Spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(Fluoroscopy guided group) | Active comparator | Procedure: Fluoroscopy guided Facet joint injectionIN 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) | Active comparator | Procedure: Ultrsound guided Facet joint injectionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoroscopy guided Facet joint injectionFluoroscopy 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.) | Procedure or surgery | Group 1(Fluoroscopy guided group) |
| Ultrsound guided Facet joint injectionUltrsound 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) | Procedure or surgery | Group2 (Ultrasound guided group) |
Primary outcome
Success rate of the technique
Time frame: 1 day
Success rate of the technique
4 secondary outcomes
The visual analogue scale (VAS) score
Time frame: Up to 3 months
Oswestry disability index. (ODI)
Time frame: Up to 3 months
Duration of procedure
Time frame: 2 hours
Complications
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Facet Syndrome of Lumbar Spine
Not yet recruiting
Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain
Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Abogabal, MSc. principal investigator
Anesthesia, ICU and pain medicine department of Tanta university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopy guided Facet joint injection and Ultrsound guided Facet joint injection in people with Facet Syndrome of Lumbar Spine, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the technique (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.