Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

Not Applicable

• Conditions: Facet Joint Pain; Facet Syndrome of Lumbar Spine; Facet Joints; Degeneration

• Registration Number: NCT03871192
• Lead Sponsor: Complejo Hospitalario Universitario de Granada

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.

Study Timeline

• Study Start: 2018-08-15
• Status Verified: 2019-03
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-10
• Study First Posted: 2019-03-12
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15
• Primary Completion: 2019-08-15
• Study Completion: 2020-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain (VAS score)	1 year	score from no pain (0) to maximum pain (10)

Secondary Outcome Measures

Name	Time	Method
Oswestry scale	1 year	score from no disability(0) to maximum disability (10)

Trial Locations

Locations (2)

Complejo Hospitalario Universitario Granada; 🇪🇸 Granada, SPA, Spain

Hospital Neuro-Traumatologia; 🇪🇸 Granada, Spain