NCT04381208

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Apr 2019Dec 2026

Study Start

First participant enrolled

April 19, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

May 5, 2020

Last Update Submit

April 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Final diagnosis

    Number of participants diagnosed with each condition of interest

    1-2 months

Study Arms (2)

Sacroiliac joint pain

Patients diagnosed with sacroiliac joint pain on the basis of history, physical examination and diagnostic sacroiliac joint block

Diagnostic Test: Complete clinical examination

Lumbar pain

Patients diagnosed with other chronic lumbar pathologies on the basis of history, physical examination and radiographic studies

Diagnostic Test: Complete clinical examination

Interventions

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

Lumbar painSacroiliac joint pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Vicente Vanaclocha Vanaclocha, Full Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

April 19, 2019

Primary Completion

March 31, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations