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Sacroiliac Joint Somatic DysfunctionSIJD-PENCT04381208

Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction

An observational study of Sacroiliac Joint Somatic Dysfunction and Low Back Pain, run by University of Valencia at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

There are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Complete clinical examination
How many people
140 participants
Where
1 siteSpain
Study dates
19 Apr 2019to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients being evaluated in the clinic for chronic low back pain or buttocks pain with or without radiation to the legs.

Who may be able to join

  • Patient being evaluated in clinic for chronic low back or buttocks pain with or without radiation to the legs

Who cannot join

  • Patient has already undergone surgery for the condition of interest
  • Inflammatory condition
  • Active cancer

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vicente Vanaclocha Vanaclocha, Full Professor contact

+34669790013

vivava@uv.es

Spain1 site, 1 recruiting
  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46015

    Vicente Vanaclocha, Professor MD PhD, +34 669 79 00 13, vvanaclo@hotmail.com

    Recruiting

Other trials in Spain

About this study

Official title: Datos de la Historia clínica y Del Examen físico y neurológico Que Orientan al diagnóstico de Dolor Originario en la articulación sacroilíaca

There are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. The diagnosis, based mostly on radiological exams, carries a risk of failure to diagnose the sacroiliac joint as the cause of the pain. The study proposes that a quick interrogatory followed by a physical exam with the adequate provocative testing can raise the suspicion of the diagnosis that the pain is originating from the sacroiliac joint. Thereafter, a diagnostic sacroiliac joint block can be performed. The study aims to correlate findings from patient history and physical examination with eventual diagnosis.

Read the detailed description

This is a prospective cohort study of patients seeking care for chronic low back pain. All patients will undergo a detailed history and physical examination, followed by other indicated diagnostic testing. The analysis will correlate findings from patient history and physical examination testing with the eventual diagnosis. The goal of the study is to identify key historical and physical examination criteria that raise the suspicion for sacroiliac joint pain, which is commonly underdiagnosed. Failure to diagnose a health condition could lead to inappropriate surgery.

Being tested
Complete clinical examination
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Complete clinical examinationDiagnostic test

    Medical history-taking, physical examination with provocative maneuvers, radiographic imaging (if relevant), and sacroiliac joint block (if indicated), facet joint block (if indicated)

Study groups in NCT04381208
Study groupRoleWhat they receive
Sacroiliac joint painPatients diagnosed with sacroiliac joint pain on the basis of history, physical examination and diagnostic sacroiliac joint block
Receives: Diagnostic Test: Complete clinical examination
Lumbar painPatients diagnosed with other chronic lumbar pathologies on the basis of history, physical examination and radiographic studies
Receives: Diagnostic Test: Complete clinical examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Final diagnosis

    Number of participants diagnosed with each condition of interest

    Measured: 1-2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start19 Apr 2019
  3. Primary completion31 Mar 2026
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381208
Sponsor's protocol ID
19-04-2019
Acronym
SIJD-PE
Status last verified
Apr 2026
First submitted
5 May 2020
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vanaclocha V, Jorda-Gomez P, Saiz-Sapena N, Vanaclocha L, Kennedy J. Diagnostic accuracy of clinical examination to distinguish sacroiliac joint pain as a cause of chronic low back pain. Br J Neurosurg. 2026 Feb;40(1):137-144. doi: 10.1080/02688697.2024.2433492. Epub 2024 Dec 10.

    PubMed 39654480

Questions about this trial

What is this clinical trial studying?

An observational study of Sacroiliac Joint Somatic Dysfunction and Low Back Pain, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vicente Vanaclocha Vanaclocha, Full Professor (+34669790013, vivava@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Final diagnosis (time frame: 1-2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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