Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001027101
Ethics application status
Approved
Date submitted
3/06/2019
Date registered
18/07/2019
Date last updated
27/11/2019
Date data sharing statement initially provided
18/07/2019
Date results information initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of foot pronation in chronic low back pain
Scientific title
Effect of foot posture in the chronic low back pain: a randomized controlled trial
Secondary ID [1] 298402 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 313100 0
Foot pronation 313101 0
Condition category
Condition code
Musculoskeletal 311582 311582 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For the total sample of Patients with nonspecific CLBP and a pronated foot posture index we evaluate the Oswestry's Disability Index Questionnaire for Lower Back Pain (ODI) and a visual analogue scale (VAS) for pain. The outcome measure of CLBP, assessed using the Oswestry Disability Index (ODI) and the Visual Analogic Scale (VAS) at the moment of the inclusión in the study. We evaluate the foot posture using the foot posture index. We are not going to do any intervention, only a observacional meassures. Is only the day of the exploration, only one meassure.
Intervention code [1] 314647 0
Diagnosis / Prognosis
Comparator / control treatment
Patients with nonspecific CLBP ( experimental group) and another control group without CLBP
Control group
Active

Outcomes
Primary outcome [1] 320286 0
Foot posture index
Timepoint [1] 320286 0
Initial Exploration ( day 1 of the inclusion in the study)
Secondary outcome [1] 371767 0
Owestry disability questionnaire
Timepoint [1] 371767 0
The day of the inclusion in the study
Secondary outcome [2] 372533 0
Gait:
Evaluation of a parameters of the gait: the number of steps in a minute.
The subject walks 4 km/ hour over a tape of running.
Timepoint [2] 372533 0
At the day of the inclusion in the study
Secondary outcome [3] 372708 0
ROM of the ankle.
Evaluation of the movement of ankle with the widespread knee. the measurement is realized in grades using a goniometer of two branches that measures the maximum ROM in flexion of the ankle.
Timepoint [3] 372708 0
At the day of the inclusion in the study

Eligibility
Key inclusion criteria
Foot pronation
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
serious illness, current participation in another research study, pregnancy, previous back or foot surgery, current treatment of foot pathology or back

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Comparison between the foot posture index, the gait and the ROM of the ankle of the groups on the total participants .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2019
Actual
31/10/2019
Date of last participant enrolment
Anticipated
29/11/2019
Actual
19/11/2019
Date of last data collection
Anticipated
29/11/2019
Actual
19/11/2019
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 21556 0
Spain
State/province [1] 21556 0
seville

Funding & Sponsors
Funding source category [1] 302942 0
University
Name [1] 302942 0
Ethics Comitee of the University of Seville.
Country [1] 302942 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
C Avicena S/N
Seville 41009
Spain

Country
Spain
Secondary sponsor category [1] 302905 0
None
Name [1] 302905 0
None
Address [1] 302905 0
NO
Country [1] 302905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303504 0
Ethics committee of the Seville University
Ethics committee address [1] 303504 0
Av. Manuel Siurot, S/n, 41013 Sevilla
Hospital Universitario Virgen del Rocío,
Spain
Ethics committee country [1] 303504 0
Spain
Date submitted for ethics approval [1] 303504 0
12/07/2011
Approval date [1] 303504 0
19/12/2018
Ethics approval number [1] 303504 0

Summary
Brief summary
Identify the foot posture index and it´s response in CLBP.
We evaluate the foot posture and the CLBP in patients with this pain to valorate if there is a disturb in the foot posture that can influence the chronic low back pain
It´s an observational study

We hypothesized that the anormal biomechanical of the foot may contribute to the low back pain symptoms. This question represents an important benefit for patients and for the public health system by reducing expensive treatments, such as surgery or long periods of rehabilitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93894 0
Dr aurora castro mendez
Address 93894 0
Aurora Castro Mendez
University of Seville
C/ Avicena S/N
Seville
41009
Spain
Country 93894 0
Spain
Phone 93894 0
+34 677608957
Fax 93894 0
Email 93894 0
auroracastro@us.es
Contact person for public queries
Name 93895 0
Dr aurora castro mendez
Address 93895 0

University of Seville. Departament of Podiatry.
Aurora Castro Mendez
C/ Avicena S/N
Seville
41009
Spain
Country 93895 0
Spain
Phone 93895 0
+34 677608957
Fax 93895 0
Email 93895 0
auroracastro@us.es
Contact person for scientific queries
Name 93896 0
Dr aurora castro mendez
Address 93896 0
University of Seville
Aurora Castro Mendez
C/ Avicena S/N
Seville
41009
Spain
Country 93896 0
Spain
Phone 93896 0
+34 677608957
Fax 93896 0
Email 93896 0
auroracastro@us.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.