An observational study in Chronic Low Back Pain and Lumbar Facet Syndrome, sponsored by ISSSTE Hospital Regional "Gral. Ignacio Zaragoza". Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" · Observational
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.
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Change in Oswestry Disability Index (ODI)
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.
Time frame: Baseline (pre-injection) and 30 days post-injection
Change in Numeric Rating Scale (NRS) pain score
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.
Time frame: Baseline, immediately post-procedure, and 30 days post-injection
Change in modified Schober test (lumbar flexion mobility)
The modified Schober test measures lumbar flexion range (cm) to evaluate biomechanical mobility. An increase of at least 5 cm indicates a functional range.
Time frame: Baseline and 30 days post-injection
Incidence of adverse events
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.
Time frame: Immediately after procedure up to 30 days post-injection
Plan to share: Yes — 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.
Supporting information: Study protocol, Clinical study report, Analytic code
Time frame: Beginning at the time of article publication, with no end date.
Access criteria: Data and code will be publicly available with no access restrictions via GitHub.
Data sharing details ↗ · github.com
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Mar 2027, 3 months later.
Of 175 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 3 months is below that.
Counting every sponsor, half of 185 studies reached it within 24 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"