NCT03880370

Brief Summary

This is a control-case study. It has been designed to determine if there is a relationship between the cross sectional (thickness), through RUSI ultrasound, of the abdominal muscles, lumbar and hip muscles with the results of the functional tests, to determine its relevance in patients with low back pain and / or ciatalgia and lumbar disc herniation in non-professional athletes. The secondary objectives of the study will be to know if there is a relationship between the results of ultrasound measurements and functional tests with the result of the disability questionnaires, the amount of pain and its location, as well as determine the relevance, depending on the results of ultrasound measurements and test of the presence or not of a lumbar disc herniation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 4, 2019

Last Update Submit

March 20, 2019

Conditions

Keywords

ultrasoundfunctional testherniated lumbar disklow back pain

Outcome Measures

Primary Outcomes (5)

  • Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis.

    Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis.

    5 minutes

  • Ultrasound changes in muscle cross-sectional area (CSA) produced of the internal oblique.

    Ultrasound changes in muscle cross-sectional area (CSA) produced of the internal oblique.

    5 minutes

  • Ultrasound changes in muscle cross-sectional area (CSA)produced of the external oblique.

    Ultrasound changes in muscle cross-sectional area (CSA) produced of the external oblique.

    5 minutes

  • Ultrasound changes in muscle cross-sectional area (CSA)produced of the rectus abdominis.

    Ultrasound changes in muscle cross-sectional area (CSA)produced of the rectus abdominis.

    5 minutes

  • Ultrasound changes in muscle cross-sectional area (CSA)produced of the lumbar multifidus.

    Ultrasound changes in muscle cross-sectional area (CSA)produced of the lumbar multifidus.

    5 minutes

Secondary Outcomes (9)

  • Ultrasound changes in muscle cross-sectional area (CSA) produced of the gluteus medius.

    10 minutes

  • Functional test. Star excursion balance test (SEBT)

    10 minutes

  • Functional test. Side bridging test

    10 minutes

  • Functional test. Modified biering-sørensen

    10 minutes

  • Functional test. Prone bridging test

    10 minutes

  • +4 more secondary outcomes

Study Arms (2)

group 1(group without low back pain)

Participants inclusion criteria an age 18 to 55 years of age who practice sports equal to greater than three hours per week who have not had low back pain or ciatalgia in the last 12 months.

Behavioral: Questionnaires / scalesDiagnostic Test: Ultrasound imagingDiagnostic Test: FLEXIBILITYDiagnostic Test: FUNCTIONAL TESTS

group 2 (low back pain group)

Participants inclusion criteria an age 18 and 55 years of age who practice sports equal to greater than three hours a week, with a history of at least one episode of low back pain and / or ciatalgia in the last 12 months lasting no longer than three months and diagnosis of hernia lumbar disc using MRI.

Behavioral: Questionnaires / scalesDiagnostic Test: Ultrasound imagingDiagnostic Test: FLEXIBILITYDiagnostic Test: FUNCTIONAL TESTS

Interventions

EVA, ROLAND MORRIS, OWESTRY and Global Questionnaire of Physical Activity (GPAQ)

group 1(group without low back pain)group 2 (low back pain group)
Ultrasound imagingDIAGNOSTIC_TEST

Rectus abdominis dominant side \& non-dominant side external oblique dominant side \& non-dominant side internal oblique dominant side \& non-dominant side transversus abdominis dominant side \& non-dominant side lumbar multififidus l4-l5-s1 gluteus medius dominant side \& non-dominant side

group 1(group without low back pain)group 2 (low back pain group)
FLEXIBILITYDIAGNOSTIC_TEST

weight-bearing lunge hip lateral rotation straight leg raise fingertip to floor test

group 1(group without low back pain)group 2 (low back pain group)
FUNCTIONAL TESTSDIAGNOSTIC_TEST

Star excursion balance test (sebt) prone bridging test Side bridging test Modified biering-sørensen

group 1(group without low back pain)group 2 (low back pain group)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Men and women between 18 and 55 years old. Non-professional sports practice equal to greater than 3 hours per week

You may qualify if:

  • Age 18 to 55 years of age.
  • Sports practice equal to greater than three hours per week.
  • No low back pain or ciatalgia in the last 12 months.

You may not qualify if:

  • Traumatic process or surgery in the lower back or lower limb in the last year.
  • Alterations of the skin or local infection in the area to be examined or that impedes the ultrasonographic measurement or performance of the functional tests.
  • Peripheral or central neurological pathology.
  • Psychiatric pathology and / or cognitive alterations.
  • Inflammatory and tumor diseases.
  • Alterations that prevent the understanding of the indications and / or the performance of the tests.
  • Group selection criteria:
  • Group 1(group without low back pain): No low back pain or ciatalgia in the last 12 months.
  • Group 2 (low back pain group): History of at least one episode of low back pain and / or ciatalgia in the last 12 months lasting no longer than three months and diagnosis of hernia lumbar disc using MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainSciatica

Interventions

Surveys and QuestionnairesWeights and MeasuresUltrasonographyPliability

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgia

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMechanical PhenomenaPhysical Phenomena

Study Officials

  • Gustavo Plaza Manzano, Pt PhD

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Miñambres Martin, Pt

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 19, 2019

Study Start

April 1, 2019

Primary Completion

September 30, 2019

Study Completion

December 31, 2019

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share