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Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

Primary Purpose

Facet Joint Pain, Facet Syndrome of Lumbar Spine, Facet Joints; Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
FACET JOINT UNDER CT GUIDANCE
NERVE BLOCK UNDER CT GUIDANCE
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
FACET JOINT UNDER ULTRASOUND GUIDANCE
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Sponsored by
Complejo Hospitalario Universitario de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facet Joint Pain focused on measuring FACET JOINTS, FACET INJECTIONS, NERVE BLOCK

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Complejo Hospitalario Universitario GranadaRecruiting
  • Hospital Neuro-TraumatologiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

FACET JOINT UNDER CT GUIDANCE

NERVE BLOCK UNDER CT GUIDANCE

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

FACET JOINT UNDER ULTRASOUND GUIDANCE

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

Arm Description

Injection of the facet joint under computed tomography guidance

Injection of the nerve under computed tomography guidance

Injection of the facet joint under fluoroscopy guidance

Injection of the nerve under ultrasound guidance

Injection of the facet joint under ultrasound guidance

Injection of the nerve under computed ultrasound guidance

Outcomes

Primary Outcome Measures

Pain (VAS score)
score from no pain (0) to maximum pain (10)

Secondary Outcome Measures

Oswestry scale
score from no disability(0) to maximum disability (10)

Full Information

First Posted
March 10, 2019
Last Updated
March 13, 2019
Sponsor
Complejo Hospitalario Universitario de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03871192
Brief Title
Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome
Official Title
Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Anticipated)
Study Completion Date
August 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complejo Hospitalario Universitario de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facet Joint Pain, Facet Syndrome of Lumbar Spine, Facet Joints; Degeneration
Keywords
FACET JOINTS, FACET INJECTIONS, NERVE BLOCK

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the patients are randomly assigned to intraarticular injection or nerve block
Masking
ParticipantOutcomes Assessor
Masking Description
The patients and the evaluator don't know if the injection was performed inside the joint or around the nerve
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FACET JOINT UNDER CT GUIDANCE
Arm Type
Experimental
Arm Description
Injection of the facet joint under computed tomography guidance
Arm Title
NERVE BLOCK UNDER CT GUIDANCE
Arm Type
Active Comparator
Arm Description
Injection of the nerve under computed tomography guidance
Arm Title
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Arm Type
Experimental
Arm Description
Injection of the facet joint under fluoroscopy guidance
Arm Title
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Arm Type
Active Comparator
Arm Description
Injection of the nerve under ultrasound guidance
Arm Title
FACET JOINT UNDER ULTRASOUND GUIDANCE
Arm Type
Experimental
Arm Description
Injection of the facet joint under ultrasound guidance
Arm Title
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Arm Type
Active Comparator
Arm Description
Injection of the nerve under computed ultrasound guidance
Intervention Type
Diagnostic Test
Intervention Name(s)
FACET JOINT UNDER CT GUIDANCE
Other Intervention Name(s)
facet joint, ct guidance
Intervention Description
injection of triamcinolone in the facet joint under CT guidance
Intervention Type
Diagnostic Test
Intervention Name(s)
NERVE BLOCK UNDER CT GUIDANCE
Other Intervention Name(s)
posterior ramus, ct guidance
Intervention Description
injection of triamcinolone around the dorsal ramus under CT guidance
Intervention Type
Diagnostic Test
Intervention Name(s)
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
Other Intervention Name(s)
facet joint, fluoroscopy guidance
Intervention Description
injection of triamcinolone in the facet joint under fluoroscopy guidance
Intervention Type
Diagnostic Test
Intervention Name(s)
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
Other Intervention Name(s)
posterior ramus, fluoroscopy guidance
Intervention Description
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
Intervention Type
Diagnostic Test
Intervention Name(s)
FACET JOINT UNDER ULTRASOUND GUIDANCE
Other Intervention Name(s)
facet joint, ultrasound guidance
Intervention Description
injection of triamcinolone in the facet joint under ultrasound guidance
Intervention Type
Diagnostic Test
Intervention Name(s)
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
Other Intervention Name(s)
dorsal ramus, ultrasound guidance
Intervention Description
injection of triamcinolone around the dorsal ramus under ultrasound guidance
Primary Outcome Measure Information:
Title
Pain (VAS score)
Description
score from no pain (0) to maximum pain (10)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Oswestry scale
Description
score from no disability(0) to maximum disability (10)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Previous back surgery and other ablative treatments. Contraindication for the use of corticosteroid or local anesthetic. Uncontrolled acute or chronic medical illness. Pregnancy or lactation. Presence of inflammatory arthropathy or neuropathy. Wounds or skin lesions in the area. Diabetes mellitus. Psychiatric disorders Refusal to participate in the study. Demonstration by imaging techniques of other causes that could justify the symptomatology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALBERTO MARTINEZ MARTINEZ, MD
Phone
+34645558225
Email
rralbert.martinez@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ana María Del Valle Díaz De La Guardia, MD
Phone
+34958895414
Email
anam.valle.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FERNANDO RUIZSANTIAGO, PhD
Organizational Affiliation
HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario Universitario Granada
City
Granada
State/Province
SPA
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUANA MARIA DE HARO CASTELLANO
Phone
+34958 020124
Email
juanam.haro.exts@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
JUAN MORALES ARCAS
Phone
+34 958 023136
Email
juan.morales.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
NICOLAS PRADOS OLLETA, PhD
First Name & Middle Initial & Last Name & Degree
FERNANDO RUIZ SANTIAGO, PhD
First Name & Middle Initial & Last Name & Degree
ALBERTO MARTINEZ MARTINEZ, MD
First Name & Middle Initial & Last Name & Degree
JADE GARCIA ESPINOSA, MD
Facility Name
Hospital Neuro-Traumatologia
City
Granada
ZIP/Postal Code
1800314
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUANA MARIA DE HARO CASTELLANO
Phone
+34958 020124
Email
juanam.haro.exts@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
JUAN MORALES ARCA
Phone
+34 958 023136
Email
juan.morales.sspa@juntadeandalucia.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

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