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Not yet recruitingNCT07929623ClinicalTrials.gov record

Fluoroscopy-Guided Lumbar Facet Block for Chronic Low Back Pain

Chronic Low Back Pain · Lumbar Facet Syndrome

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
18 years - 75 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Study population

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.

Understand screening

Treatment, groups and participation

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Assignment
Not reported
Masking
Not reported
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).

Procedure: Fluoroscopy-guided lumbar facet block

Fluoroscopy-guided lumbar facet block PROCEDURE

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Change in Oswestry Disability Index (ODI)

Time frame: 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.

Secondary measures

Change in Numeric Rating Scale (NRS) pain score

Time frame: 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.

Change in modified Schober test (lumbar flexion mobility)

Time frame: 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.

Incidence of adverse events

Time frame: 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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

Centro Médico Nacional 20 de Noviembre, ISSSTEMexico City, Mexico City, MexicoStatus unknown
Paola Estefania Vallejo Mora, MDCONTACTpaovallejo100177@gmail.com+52 56 3125 6766
Sergio Tenopala Villegas, MDCONTACTdrstenopala@yahoo.com.mx+52 55 5412 0375
View location on map ↗

Study team and timeline

Lead sponsor
ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"
Study start
2026-12 Estimated
Primary completion
2027-03 Estimated
Study completion
2027-06 Estimated
First posted
Nov 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Paola Estefania Vallejo Mora, MDCONTACTpaovallejo100177@gmail.com+52 56 3125 6766
Sergio Tenopala Villegas, MDCONTACTdrstenopala@yahoo.com.mx+52 55 5412 0375
Official study title

Evaluation of Functionality and Pain After Fluoroscopy-Guided Lumbar Facet Block: A Prospective and Longitudinal Study

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026