Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

Facet Joint Pain Clinical Trial

Official title:

Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03871192
• Other study ID #: 0607-N-18
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: August 15, 2020

Study information

• Verified date: March 2019
• Source: Complejo Hospitalario Universitario de Granada
• Contact: ALBERTO MARTINEZ MARTINEZ, MD
• Phone: +34645558225
• Email: rralbert.martinez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• FACET JOINT UNDER CT GUIDANCE
injection of triamcinolone in the facet joint under CT guidance
• NERVE BLOCK UNDER CT GUIDANCE
injection of triamcinolone around the dorsal ramus under CT guidance
• FACET JOINT UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone in the facet joint under fluoroscopy guidance
• NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
• FACET JOINT UNDER ULTRASOUND GUIDANCE
injection of triamcinolone in the facet joint under ultrasound guidance
• NERVE BLOCK UNDER ULTRASOUND GUIDANCE
injection of triamcinolone around the dorsal ramus under ultrasound guidance

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario Granada	Granada	SPA
Spain	Hospital Neuro-Traumatologia	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Complejo Hospitalario Universitario de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VAS score)	score from no pain (0) to maximum pain (10)	1 year
Secondary	Oswestry scale	score from no disability(0) to maximum disability (10)	1 year