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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

100

Phase

  • 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 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

Ages Eligible for Study

16 years to 77 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
Intervention / Treatment
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

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

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

Complejo Hospitalario Universitario de Granada

Investigators

  • 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)

August 15, 2018

Primary Completion (Anticipated)

August 15, 2019

Study Completion (Anticipated)

August 15, 2020

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 10, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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