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Hallux Limitus in Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT04607863
Recruitment Status : Not yet recruiting
First Posted : October 29, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Aurora Castro Mendez, University of Seville

Study Description
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Brief Summary:
Foot disorders have been recognized as being linked to chronic low back pain

Condition or disease Intervention/treatment
Hallux Limitus Movement, Abnormal Back Pain Lower Back Chronic Diagnostic Test: Case control

Detailed Description:

Foot disorders have been recognized as being linked to chronic low back pain (CLBP), To improve knowledge of the relationship between the limitation of the movement range of hallux (HROML) is important about it can affect the back biomechanical . The aim of this research is to investigate if the HROML may appear as a risk factor of CLBP

HROML affect the foot position, and consecuently may induce to alter as compensatory mechanism the normal biomechanical of the leg, hip and back.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: The Hallux Limitus Connection With Chronic Low Back Pain
Estimated Study Start Date : October 23, 2020
Estimated Primary Completion Date : November 2, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Groups and Cohorts
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Group/Cohort Intervention/treatment
Low back pain
Patients with low back pain
 Diagnostic Test: Case control
Is a case-control research
No low back pain
No low back pain patients
 Diagnostic Test: Case control
Is a case-control research


Outcome Measures
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Primary Outcome Measures :
  1. Hallux dorsal movement range degrees [ Time Frame: A day, the inclusion day in the study ]
    Goniometer to examinate the range of hallux dorsal movement


Secondary Outcome Measures :
  1. Low back pain [ Time Frame: a day, the inclusion day in the study ]
    questionnary oswestry disability index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Males and females between 18 and 65 years old
Criteria

Inclusion Criteria: males and females between 18 to 65 years old Hallux limitus in one or two feet -

Exclusion Criteria:

serious illness, current participation in another research study pregnancy previus foot or back surgery

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607863


Locations
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Spain
Aurora Castro Mendez
Sevilla, Spain, 41018
Sponsors and Collaborators
University of Seville
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Aurora Castro Mendez, Aurora Castro-Méndez, University of Seville
ClinicalTrials.gov Identifier: NCT04607863    
Other Study ID Numbers: 23/11
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aurora Castro Mendez, University of Seville:
foot
hallux
limitus
back
Additional relevant MeSH terms:
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Hallux Limitus
Hallux Rigidus
Dyskinesias
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Foot Deformities, Acquired
Foot Deformities
 Musculoskeletal Diseases
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases