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Status unknownNCT03871192Updated Mar 15, 2019

Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

An interventional study of FACET JOINT UNDER CT GUIDANCE and NERVE BLOCK UNDER CT GUIDANCE in Facet Joint Pain, Facet Syndrome of Lumbar Spine and Facet Joints; Degeneration, sponsored by Complejo Hospitalario Universitario de Granada. Status unknown at 2 sites in Spain. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Complejo Hospitalario Universitario de Granada · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Aug 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • FACET JOINTS
  • FACET INJECTIONS
  • NERVE BLOCK
03

In context

Arthralgia

273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.

This study's planned enrollment of 100 is above the median of 63 across 219 interventional studies indexed under Arthralgia.

Browse Arthralgia studies →

Lead sponsor

Complejo Hospitalario Universitario de Granada is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    FACET JOINT UNDER CT GUIDANCE

    Injection of the facet joint under computed tomography guidance

    Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE · Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE

  • Active comparator
    NERVE BLOCK UNDER CT GUIDANCE

    Injection of the nerve under computed tomography guidance

    Diagnostic Test: FACET JOINT UNDER CT GUIDANCE · Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE

  • Experimental
    FACET JOINT UNDER FLUOROSCOPY GUIDANCE

    Injection of the facet joint under fluoroscopy guidance

    Diagnostic Test: FACET JOINT UNDER CT GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE

  • Active comparator
    NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

    Injection of the nerve under ultrasound guidance

    Diagnostic Test: FACET JOINT UNDER CT GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE · Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE

  • Experimental
    FACET JOINT UNDER ULTRASOUND GUIDANCE

    Injection of the facet joint under ultrasound guidance

    Diagnostic Test: FACET JOINT UNDER CT GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE · Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER ULTRASOUND GUIDANCE

  • Active comparator
    NERVE BLOCK UNDER ULTRASOUND GUIDANCE

    Injection of the nerve under computed ultrasound guidance

    Diagnostic Test: FACET JOINT UNDER CT GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER CT GUIDANCE · Diagnostic Test: FACET JOINT UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE · Diagnostic Test: FACET JOINT UNDER ULTRASOUND GUIDANCE

Interventions

  • Diagnostic testFACET JOINT UNDER CT GUIDANCE

    injection of triamcinolone in the facet joint under CT guidance

    Also known as: facet joint, ct guidance

  • Diagnostic testNERVE BLOCK UNDER CT GUIDANCE

    injection of triamcinolone around the dorsal ramus under CT guidance

    Also known as: posterior ramus, ct guidance

  • Diagnostic testFACET JOINT UNDER FLUOROSCOPY GUIDANCE

    injection of triamcinolone in the facet joint under fluoroscopy guidance

    Also known as: facet joint, fluoroscopy guidance

  • Diagnostic testNERVE BLOCK UNDER FLUOROSCOPY GUIDANCE

    injection of triamcinolone around the dorsal ramus under fluoroscopy guidance

    Also known as: posterior ramus, fluoroscopy guidance

  • Diagnostic testFACET JOINT UNDER ULTRASOUND GUIDANCE

    injection of triamcinolone in the facet joint under ultrasound guidance

    Also known as: facet joint, ultrasound guidance

  • Diagnostic testNERVE BLOCK UNDER ULTRASOUND GUIDANCE

    injection of triamcinolone around the dorsal ramus under ultrasound guidance

    Also known as: dorsal ramus, ultrasound guidance

06

What researchers measure

Primary outcomes

  1. Pain (VAS score)

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

    Time frame: 1 year

Secondary outcomes

  1. Oswestry scale

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

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03871192
Lead sponsor
Complejo Hospitalario Universitario de Granada
Responsible party
FERNANDO RUIZ SANTIAGO (PhD, section chief musculoskeletal radiology, Complejo Hospitalario Universitario de Granada) — Principal investigator
First posted
Mar 12, 2019
Start date
Aug 15, 2018
Primary completion
Aug 15, 2019 (estimated)
Completion
Aug 15, 2020 (estimated)
Last update
Mar 15, 2019

Study contacts

ALBERTO MARTINEZ MARTINEZ, MD
Contact
rralbert.martinez@gmail.com
+34645558225
Ana María Del Valle Díaz De La Guardia, MD
Contact
anam.valle.sspa@juntadeandalucia.es
+34958895414
FERNANDO RUIZSANTIAGO, PhD
principal investigator · HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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