Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

NCT ID: NCT03871192

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2020-08-15

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the patients are randomly assigned to intraarticular injection or nerve block
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patients and the evaluator don't know if the injection was performed inside the joint or around the nerve

Study Groups

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FACET JOINT UNDER CT GUIDANCE

Injection of the facet joint under computed tomography guidance

Group Type EXPERIMENTAL

NERVE BLOCK UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under CT guidance

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under fluoroscopy guidance

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under fluoroscopy guidance

FACET JOINT UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under ultrasound guidance

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under ultrasound guidance

NERVE BLOCK UNDER CT GUIDANCE

Injection of the nerve under computed tomography guidance

Group Type ACTIVE_COMPARATOR

FACET JOINT UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under CT guidance

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under fluoroscopy guidance

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under fluoroscopy guidance

FACET JOINT UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under ultrasound guidance

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under ultrasound guidance

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

Injection of the facet joint under fluoroscopy guidance

Group Type EXPERIMENTAL

FACET JOINT UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under CT guidance

NERVE BLOCK UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under CT guidance

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under fluoroscopy guidance

FACET JOINT UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under ultrasound guidance

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under ultrasound guidance

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

Injection of the nerve under ultrasound guidance

Group Type ACTIVE_COMPARATOR

FACET JOINT UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under CT guidance

NERVE BLOCK UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under CT guidance

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under fluoroscopy guidance

FACET JOINT UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under ultrasound guidance

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under ultrasound guidance

FACET JOINT UNDER ULTRASOUND GUIDANCE

Injection of the facet joint under ultrasound guidance

Group Type EXPERIMENTAL

FACET JOINT UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under CT guidance

NERVE BLOCK UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under CT guidance

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under fluoroscopy guidance

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under fluoroscopy guidance

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under ultrasound guidance

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

Injection of the nerve under computed ultrasound guidance

Group Type ACTIVE_COMPARATOR

FACET JOINT UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under CT guidance

NERVE BLOCK UNDER CT GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under CT guidance

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under fluoroscopy guidance

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone around the dorsal ramus under fluoroscopy guidance

FACET JOINT UNDER ULTRASOUND GUIDANCE

Intervention Type DIAGNOSTIC_TEST

injection of triamcinolone in the facet joint under ultrasound guidance

Interventions

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FACET JOINT UNDER CT GUIDANCE

injection of triamcinolone in the facet joint under CT guidance

Intervention Type DIAGNOSTIC_TEST

NERVE BLOCK UNDER CT GUIDANCE

injection of triamcinolone around the dorsal ramus under CT guidance

Intervention Type DIAGNOSTIC_TEST

FACET JOINT UNDER FLUOROSCOPY GUIDANCE

injection of triamcinolone in the facet joint under fluoroscopy guidance

Intervention Type DIAGNOSTIC_TEST

NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

injection of triamcinolone around the dorsal ramus under fluoroscopy guidance

Intervention Type DIAGNOSTIC_TEST

FACET JOINT UNDER ULTRASOUND GUIDANCE

injection of triamcinolone in the facet joint under ultrasound guidance

Intervention Type DIAGNOSTIC_TEST

NERVE BLOCK UNDER ULTRASOUND GUIDANCE

injection of triamcinolone around the dorsal ramus under ultrasound guidance

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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facet joint ct guidance posterior ramus ct guidance facet joint fluoroscopy guidance posterior ramus fluoroscopy guidance facet joint ultrasound guidance dorsal ramus ultrasound guidance

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Complejo Hospitalario Universitario de Granada

OTHER

Sponsor Role lead

Responsible Party

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FERNANDO RUIZ SANTIAGO

PhD, section chief musculoskeletal radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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FERNANDO RUIZSANTIAGO, PhD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)

Locations

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Complejo Hospitalario Universitario Granada

Granada, SPA, Spain

Site Status RECRUITING

Hospital Neuro-Traumatologia

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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ALBERTO MARTINEZ MARTINEZ, MD

Role: CONTACT

+34645558225

Ana María Del Valle Díaz De La Guardia, MD

Role: CONTACT

+34958895414

Facility Contacts

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JUANA MARIA DE HARO CASTELLANO

Role: primary

+34958 020124

JUAN MORALES ARCAS

Role: backup

+34 958 023136

JUANA MARIA DE HARO CASTELLANO

Role: primary

+34958 020124

JUAN MORALES ARCA

Role: backup

+34 958 023136

Other Identifiers

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0607-N-18

Identifier Type: -

Identifier Source: org_study_id

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