Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

March 13, 2019 updated by: FERNANDO RUIZ SANTIAGO, Complejo Hospitalario Universitario de Granada

Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome

In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Facet joint pain is considered as a nonspecific cause of spinal pain with an estimated prevalence of 12-61% of the population. At present, there are no unanimous clinical criteria to achieve and accurate diagnosis and the imaging findings do not show a direct correlation with the clinical symptoms.

Facet syndrome treatment is also controversial and, although most clinical guidelines recommend nerve block as a diagnostic test, followed by neurolysis as therapeutic technique, there are many detractors of this therapeutic sequence.

The confusion is even greater when considering the variability of specialists who perform these techniques, the variability of methods used ranging from blind injections to injections guided by ultrasound, fluoroscopy or CT, or the amount of medication injected.

The investigators have long experience in the percutaneous treatment of pain and in the use of different imaging techniques. Although the investigators objectives are multiple, the main one is to know if there are any difference in the outcome of the facet syndrome treated by intra-articular injections and the block of the medial branch of the dorsal branch of the spinal nerve.

Along with the collaboration of other specialists the investigators want to address secondary objectives such as the usefulness of ultrasound and fluoroscopy in the treatment of facet syndrome and its comparison with those performed under CT guidance that is considered as the standard technique for its greater precision.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • SPA
      • Granada, SPA, Spain, 18014
        • Recruiting
        • Complejo Hospitalario Universitario Granada
        • Contact:
        • Contact:
        • Sub-Investigator:
          • NICOLAS PRADOS OLLETA, PhD
        • Principal Investigator:
          • FERNANDO RUIZ SANTIAGO, PhD
        • Sub-Investigator:
          • ALBERTO MARTINEZ MARTINEZ, MD
        • Sub-Investigator:
          • JADE GARCIA ESPINOSA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1- Lumbar facet syndrome diagnosed by the referring specialist: Rehabilitation, Traumatology or Neurosurgery 2 -Mechanical low back pain that increases with rotation and flexion-extension, without radicular irradiation.

3- failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months

Exclusion Criteria:

  1. Previous back surgery and other ablative treatments.
  2. Contraindication for the use of corticosteroid or local anesthetic.
  3. Uncontrolled acute or chronic medical illness.
  4. Pregnancy or lactation.
  5. Presence of inflammatory arthropathy or neuropathy.
  6. Wounds or skin lesions in the area.
  7. Diabetes mellitus.
  8. Psychiatric disorders
  9. Refusal to participate in the study.
  10. Demonstration by imaging techniques of other causes that could justify the symptomatology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FACET JOINT UNDER CT GUIDANCE
Injection of the facet joint under computed tomography guidance
Diagnostic test: NERVE BLOCK UNDER CT GUIDANCE
injection of triamcinolone around the dorsal ramus under CT guidance
Other Names:
  • ct guidance
  • posterior ramus
Diagnostic test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone in the facet joint under fluoroscopy guidance
Other Names:
  • facet joint
  • fluoroscopy guidance
Diagnostic test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
Other Names:
  • posterior ramus
  • fluoroscopy guidance
Diagnostic test: FACET JOINT UNDER ULTRASOUND GUIDANCE
injection of triamcinolone in the facet joint under ultrasound guidance
Other Names:
  • facet joint
  • ultrasound guidance
Diagnostic test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE
injection of triamcinolone around the dorsal ramus under ultrasound guidance
Other Names:
  • ultrasound guidance
  • dorsal ramus
Active Comparator: NERVE BLOCK UNDER CT GUIDANCE
Injection of the nerve under computed tomography guidance
Diagnostic test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone in the facet joint under fluoroscopy guidance
Other Names:
  • facet joint
  • fluoroscopy guidance
Diagnostic test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
Other Names:
  • posterior ramus
  • fluoroscopy guidance
Diagnostic test: FACET JOINT UNDER ULTRASOUND GUIDANCE
injection of triamcinolone in the facet joint under ultrasound guidance
Other Names:
  • facet joint
  • ultrasound guidance
Diagnostic test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE
injection of triamcinolone around the dorsal ramus under ultrasound guidance
Other Names:
  • ultrasound guidance
  • dorsal ramus
Diagnostic test: FACET JOINT UNDER CT GUIDANCE
injection of triamcinolone in the facet joint under CT guidance
Other Names:
  • facet joint
  • ct guidance
Experimental: FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Injection of the facet joint under fluoroscopy guidance
Diagnostic test: NERVE BLOCK UNDER CT GUIDANCE
injection of triamcinolone around the dorsal ramus under CT guidance
Other Names:
  • ct guidance
  • posterior ramus
Diagnostic test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
Other Names:
  • posterior ramus
  • fluoroscopy guidance
Diagnostic test: FACET JOINT UNDER ULTRASOUND GUIDANCE
injection of triamcinolone in the facet joint under ultrasound guidance
Other Names:
  • facet joint
  • ultrasound guidance
Diagnostic test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE
injection of triamcinolone around the dorsal ramus under ultrasound guidance
Other Names:
  • ultrasound guidance
  • dorsal ramus
Diagnostic test: FACET JOINT UNDER CT GUIDANCE
injection of triamcinolone in the facet joint under CT guidance
Other Names:
  • facet joint
  • ct guidance
Active Comparator: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Injection of the nerve under ultrasound guidance
Diagnostic test: NERVE BLOCK UNDER CT GUIDANCE
injection of triamcinolone around the dorsal ramus under CT guidance
Other Names:
  • ct guidance
  • posterior ramus
Diagnostic test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone in the facet joint under fluoroscopy guidance
Other Names:
  • facet joint
  • fluoroscopy guidance
Diagnostic test: FACET JOINT UNDER ULTRASOUND GUIDANCE
injection of triamcinolone in the facet joint under ultrasound guidance
Other Names:
  • facet joint
  • ultrasound guidance
Diagnostic test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE
injection of triamcinolone around the dorsal ramus under ultrasound guidance
Other Names:
  • ultrasound guidance
  • dorsal ramus
Diagnostic test: FACET JOINT UNDER CT GUIDANCE
injection of triamcinolone in the facet joint under CT guidance
Other Names:
  • facet joint
  • ct guidance
Experimental: FACET JOINT UNDER ULTRASOUND GUIDANCE
Injection of the facet joint under ultrasound guidance
Diagnostic test: NERVE BLOCK UNDER CT GUIDANCE
injection of triamcinolone around the dorsal ramus under CT guidance
Other Names:
  • ct guidance
  • posterior ramus
Diagnostic test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone in the facet joint under fluoroscopy guidance
Other Names:
  • facet joint
  • fluoroscopy guidance
Diagnostic test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
Other Names:
  • posterior ramus
  • fluoroscopy guidance
Diagnostic test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE
injection of triamcinolone around the dorsal ramus under ultrasound guidance
Other Names:
  • ultrasound guidance
  • dorsal ramus
Diagnostic test: FACET JOINT UNDER CT GUIDANCE
injection of triamcinolone in the facet joint under CT guidance
Other Names:
  • facet joint
  • ct guidance
Active Comparator: NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Injection of the nerve under computed ultrasound guidance
Diagnostic test: NERVE BLOCK UNDER CT GUIDANCE
injection of triamcinolone around the dorsal ramus under CT guidance
Other Names:
  • ct guidance
  • posterior ramus
Diagnostic test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone in the facet joint under fluoroscopy guidance
Other Names:
  • facet joint
  • fluoroscopy guidance
Diagnostic test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
Other Names:
  • posterior ramus
  • fluoroscopy guidance
Diagnostic test: FACET JOINT UNDER ULTRASOUND GUIDANCE
injection of triamcinolone in the facet joint under ultrasound guidance
Other Names:
  • facet joint
  • ultrasound guidance
Diagnostic test: FACET JOINT UNDER CT GUIDANCE
injection of triamcinolone in the facet joint under CT guidance
Other Names:
  • facet joint
  • ct guidance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain (VAS score)
Time Frame: 1 year
score from no pain (0) to maximum pain (10)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oswestry scale
Time Frame: 1 year
score from no disability(0) to maximum disability (10)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Complejo Hospitalario Universitario de Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: FERNANDO RUIZSANTIAGO, PhD, HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0607-N-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.

IPD Sharing Time Frame

1 to 2 years

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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