NCT04607863

Brief Summary

Foot disorders have been recognized as being linked to chronic low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 23, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 8, 2021

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

October 23, 2020

Last Update Submit

April 5, 2021

Conditions

Hallux LimitusMovement, AbnormalBack Pain Lower Back Chronic

Keywords

foothalluxlimitusback

Outcome Measures

Primary Outcomes (1)

  • Hallux dorsal movement range degrees

    Goniometer to examinate the range of hallux dorsal movement

    A day, the inclusion day in the study

Secondary Outcomes (1)

  • Low back pain

    a day, the inclusion day in the study

Study Arms (2)

Low back pain

Patients with low back pain

Diagnostic Test: Case control

No low back pain

No low back pain patients

Diagnostic Test: Case control

Interventions

Case controlDIAGNOSTIC_TEST

Is a case-control research

Low back painNo low back pain

Eligibility Criteria

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

Males and females between 18 and 65 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora Castro Mendez

Seville, 41018, Spain

Location

MeSH Terms

Conditions

Hallux LimitusDyskinesias

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint DiseasesFoot InjuriesLeg InjuriesWounds and InjuriesMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aurora Castro-Méndez

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 29, 2020

Study Start

January 23, 2020

Primary Completion

November 2, 2020

Study Completion

December 30, 2020

Last Updated

April 8, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)