Clinical trial NCT03871192: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Facet Joint Pain
Facet Syndrome of Lumbar Spine
Facet Joints; Degeneration
Keywords: FACET JOINTS
FACET INJECTIONS
NERVE BLOCK
Lead sponsor: Complejo Hospitalario Universitario de Granada
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the patients are randomly assigned to intraarticular injection or nerve block
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Pain (VAS score)
timeFrame: 1 year
Secondary outcomes:
measure: Oswestry scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario Granada
state: SPA
city: Granada
country: Spain
facility: Hospital Neuro-Traumatologia
Study officials:
affiliation: HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)
name: FERNANDO RUIZSANTIAGO, PhD
role: PRINCIPAL_INVESTIGATOR
References: