Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor

• Sponsor: University of Seville (Other)
• Overall Status: Completed
• CT.gov ID: NCT04607863
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 11.2
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Foot Posture Index Pronated, Hallux Limitus Connection and Chronic Low Back Pain Gait Parametrers With Optogait Sensor
• Actual Study Start Date: Jan 23, 2020
• Actual Primary Completion Date: Nov 2, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Hallux dorsal movement range degrees [A day, the inclusion day in the study]

   Goniometer to examinate the range of hallux dorsal movement

Secondary Outcome Measures

1. Low back pain [a day, the inclusion day in the study]

   questionnary oswestry disability index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Aurora Castro Mendez	Sevilla		Spain	41018

Sponsors and Collaborators

• University of Seville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aurora Castro Mendez, Aurora Castro-Méndez, University of Seville
• ClinicalTrials.gov Identifier: NCT04607863
• Other Study ID Numbers: 23/11
• First Posted: Oct 29, 2020
• Last Update Posted: Apr 8, 2021
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aurora Castro Mendez, Aurora Castro-Méndez, University of Seville: foot; hallux; limitus; back
• Additional relevant MeSH terms: Hallux Limitus; Hallux Rigidus; Dyskinesias; Back Pain; Low Back Pain

Study Results

No Results Posted as of Apr 8, 2021