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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Paola Estefania Vallejo Mora, MD
- Telefonnummer: +52 56 3125 6766
- E-post: paovallejo100177@gmail.com
Studer Kontakt Backup
- Navn: Sergio Tenopala Villegas, MD
- Telefonnummer: +52 55 5412 0375
- E-post: drstenopala@yahoo.com.mx
Studiesteder
-
-
Mexico City
-
Mexico City, Mexico City, Mexico, 03229
- Centro Médico Nacional 20 de Noviembre, ISSSTE
-
Ta kontakt med:
- Paola Estefania Vallejo Mora, MD
- Telefonnummer: +52 56 3125 6766
- E-post: paovallejo100177@gmail.com
-
Ta kontakt med:
- Sergio Tenopala Villegas, MD
- Telefonnummer: +52 55 5412 0375
- E-post: drstenopala@yahoo.com.mx
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Oswestry Disability Index (ODI)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Numeric Rating Scale (NRS) pain score
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sergio Tenopala Villegas, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
- Underetterforsker: Paola Estefania Vallejo Mora, MD, Centro Médico Nacional 20 de Noviembre, ISSSTE
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- RAI.CMN.373.2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Beginning at the time of article publication, with no end date.
Tilgangskriterier for IPD-deling
Data and code will be publicly available with no access restrictions via GitHub.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .