Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome
Comparison of Facet Nerve Block Versus Intra-articular Injection in the Diagnosis and Treatment of Lumbar Facet Syndrome
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2018
CompletedFirst Submitted
Initial submission to the registry
March 10, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2020
CompletedMarch 15, 2019
March 1, 2019
1 year
March 10, 2019
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain (VAS score)
score from no pain (0) to maximum pain (10)
1 year
Secondary Outcomes (1)
Oswestry scale
1 year
Study Arms (6)
FACET JOINT UNDER CT GUIDANCE
EXPERIMENTALInjection of the facet joint under computed tomography guidance
NERVE BLOCK UNDER CT GUIDANCE
ACTIVE COMPARATORInjection of the nerve under computed tomography guidance
FACET JOINT UNDER FLUOROSCOPY GUIDANCE
EXPERIMENTALInjection of the facet joint under fluoroscopy guidance
NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE
ACTIVE COMPARATORInjection of the nerve under ultrasound guidance
FACET JOINT UNDER ULTRASOUND GUIDANCE
EXPERIMENTALInjection of the facet joint under ultrasound guidance
NERVE BLOCK UNDER ULTRASOUND GUIDANCE
ACTIVE COMPARATORInjection of the nerve under computed ultrasound guidance
Interventions
injection of triamcinolone in the facet joint under CT guidance
injection of triamcinolone around the dorsal ramus under CT guidance
injection of triamcinolone in the facet joint under fluoroscopy guidance
injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
injection of triamcinolone in the facet joint under ultrasound guidance
injection of triamcinolone around the dorsal ramus under ultrasound guidance
Eligibility Criteria
You may qualify if:
- 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.
- failure of conservative treatment (pharmacological and physical therapy). 4-Symptoms present more than 3 months
You may not qualify if:
- Previous back surgery and other ablative treatments.
- Contraindication for the use of corticosteroid or local anesthetic.
- Uncontrolled acute or chronic medical illness.
- Pregnancy or lactation.
- Presence of inflammatory arthropathy or neuropathy.
- Wounds or skin lesions in the area.
- Diabetes mellitus.
- Psychiatric disorders
- Refusal to participate in the study.
- Demonstration by imaging techniques of other causes that could justify the symptomatology.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Complejo Hospitalario Universitario Granada
Granada, SPA, 18014, Spain
Hospital Neuro-Traumatologia
Granada, 1800314, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
FERNANDO RUIZSANTIAGO, PhD
HOSPITAL DE NEURO-TRAUMATOLOGIA GRANADA (VIRGEN DE LAS NIEVES)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The patients and the evaluator don't know if the injection was performed inside the joint or around the nerve
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, section chief musculoskeletal radiology
Study Record Dates
First Submitted
March 10, 2019
First Posted
March 12, 2019
Study Start
August 15, 2018
Primary Completion
August 15, 2019
Study Completion
August 15, 2020
Last Updated
March 15, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 1 to 2 years
- Access Criteria
- open access
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.