Fluoroscopy-Guided Lumbar Facet Block for Chronic Low Back Pain
Evaluation of Functionality and Pain After Fluoroscopy-Guided Lumbar Facet Block: A Prospective and Longitudinal Study
This prospective, longitudinal observational study evaluates functional recovery, pain intensity, and lumbar mobility after a fluoroscopy-guided lumbar facet joint block in patients with chronic lumbar facet syndrome. Forty patients receiving standard-of-care injections (ropivacaine 0.2% and methylprednisolone) will be observed. Outcomes are measured at baseline and 30 days post-intervention. The primary outcome is the change in Oswestry Disability Index (ODI). Secondary outcomes include changes in the Numeric Rating Scale (NRS) and the modified Schober test.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Chronic low back pain due to facet joint arthropathy is a common cause of disability.
Fluoroscopy-guided facet joint blocks are widely used in standard practice, but evidence quantifying objective functional and biomechanical recovery beyond pain reduction is limited.
This single-center, prospective, observational, longitudinal study aims to objectively quantify functional recovery. Forty patients aged 18-75 years with clinically and radiologically confirmed lumbar facet syndrome will be observed. The intervention (unilateral fluoroscopy-guided injection of ropivacaine 0.2% [0.5-1 mL] and methylprednisolone into the affected facet joint) is performed strictly as part of routine clinical care, independent of study inclusion.
Assessments occur at baseline (T0) and 30 days post-injection (T1). The primary outcome is the change in Oswestry Disability Index (ODI) score. Secondary outcomes are changes in Numeric Rating Scale (NRS) pain scores and the modified Schober test (cm). Adverse events and procedural safety are recorded. The study aims to provide preliminary effect estimates to inform future controlled trials.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Paola Estefania Vallejo Mora, MD
- Telefonnummer: +52 56 3125 6766
- E-post: paovallejo100177@gmail.com
Studera Kontakt Backup
- Namn: Sergio Tenopala Villegas, MD
- Telefonnummer: +52 55 5412 0375
- E-post: drstenopala@yahoo.com.mx
Studieorter
-
-
Mexico City
-
Mexico City, Mexico City, Mexiko, 03229
- Centro Médico Nacional 20 de Noviembre, ISSSTE
-
Kontakt:
- Paola Estefania Vallejo Mora, MD
- Telefonnummer: +52 56 3125 6766
- E-post: paovallejo100177@gmail.com
-
Kontakt:
- Sergio Tenopala Villegas, MD
- Telefonnummer: +52 55 5412 0375
- E-post: drstenopala@yahoo.com.mx
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adults aged 18-75 years with chronic low back pain (>3 months) due to lumbar facet syndrome confirmed by clinical examination and imaging, presenting to the Algology outpatient clinic.
Beskrivning
Inclusion Criteria:
- Age 18-75 years
- Clinical and radiological diagnosis of lumbar facet syndrome
- Low back pain duration >3 months
- Baseline NRS pain score ≥4/10
- Signed informed consent for the procedure and study participation
- Cognitive capacity to independently complete the Oswestry Disability Index
Exclusion Criteria:
- Radicular pain or confirmed disc herniation with neural compression
- Coagulopathy or use of anticoagulants not discontinued appropriately
- Active systemic or local infection
- Known allergy to local anaesthetics or corticosteroids
- Pregnancy or lactation
- Previous lumbar spine surgery at the same level
- Inability to comply with follow-up schedule
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Facet Block
Single group receiving standard-of-care fluoroscopy-guided lumbar facet joint injection of ropivacaine 0.2% (0.5-1 mL) and methylprednisolone into the affected facet joint(s). |
Under fluoroscopic guidance, a 20G Quincke needle is placed into the target lumbar facet joint or onto the adjacent medial branch. An arthrogram is performed with 0.3 to 0.5 mL of non-ionic contrast to confirm correct dispersion and exclude vascular/intrathecal uptake. Subsequently, 0.5 to 1 mL of a mixture containing ropivacaine 0.2% and methylprednisolone is injected per level. Performed on an outpatient basis under standard monitoring. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Oswestry Disability Index (ODI)
Tidsram: Baseline (pre-injection) and 30 days post-injection
|
The Oswestry Disability Index (ODI) is a 10-item questionnaire that measures functional disability in daily activities (0% = no disability, 100% = severe disability). The primary outcome is the change in ODI score from baseline to 30 days. A reduction of ≥10 points is considered clinically significant. |
Baseline (pre-injection) and 30 days post-injection
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Numeric Rating Scale (NRS) pain score
Tidsram: Baseline, immediately post-procedure, and 30 days post-injection
|
Pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). A clinically significant reduction is defined as at least a 50% decrease from the baseline score. |
Baseline, immediately post-procedure, and 30 days post-injection
|
|
Change in modified Schober test (lumbar flexion mobility)
Tidsram: Baseline and 30 days post-injection
|
The modified Schober test measures lumbar flexion range (cm) to evaluate biomechanical mobility. An increase of at least 5 cm indicates a functional range. |
Baseline and 30 days post-injection
|
|
Incidence of adverse events
Tidsram: Immediately after procedure up to 30 days post-injection
|
Record of any adverse events including pain at injection site, transient exacerbation of pain, allergic reaction, inadvertent dural puncture, spinal haematoma, or nerve root injury. |
Immediately after procedure up to 30 days post-injection
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Sergio Tenopala Villegas, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
- Underutredare: Paola Estefania Vallejo Mora, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- RAI.CMN.373.2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
De-identified individual participant data underlying the results reported in this study, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository.
Tidsram för IPD-delning
Beginning at the time of article publication, with no end date.
Kriterier för IPD Sharing Access
Data and code will be publicly available with no access restrictions via GitHub.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
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