Hallux LimitusNCT04607863
Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor
An observational study of Hallux Limitus and Movement, Abnormal, run by University of Seville at 1 site in Spain.
Trial summary
Foot disorders have been recognized as being linked to chronic low back pain Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Limitus, Movement, Abnormal, Back Pain Lower Back Chronic
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2020to 30 Dec 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females between 18 and 65 years old
Who may be able to join
None listed.
Who cannot join
- serious illness, current participation in another research study pregnancy previus foot or back surgery
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foot Posture Index Pronated, Hallux Limitus Connection and Chronic Low Back Pain Gait Parametrers With Optogait Sensor
Foot disorders have been recognized as being linked to chronic low back pain
Read the 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.
- Being tested
- Case control
- Keywords
- foot, hallux, limitus, back
- Medical subject headings
- Hallux Limitus, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case controlDiagnostic test
Is a case-control research
| Study group | Role | What they receive |
|---|---|---|
| Low back pain | Patients with low back pain Receives: Diagnostic Test: Case control | |
| No low back pain | No low back pain patients Receives: Diagnostic Test: Case control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux dorsal movement range degrees
Goniometer to examinate the range of hallux dorsal movement
Measured: A day, the inclusion day in the study
Secondary outcomes (1)
Low back pain
questionnary oswestry disability index
Measured: a day, the inclusion day in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start23 Jan 2020
- Primary completion2 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux LimitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurora Castro Mendez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607863
- Sponsor's protocol ID
- 23/11
- Status last verified
- Jan 2020
- First submitted
- 23 Oct 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Posture Index Pronated, Hallux Limitus Connection and Chronic Low Back Pain Gait Parametrers With Optogait Sensor
- ClinicalTrials.gov ID
- NCT04607863
- Acronym / sponsor ID
- 23/11
- Keywords
- foot, hallux, limitus, back
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Foot disorders have been recognized as being linked to chronic low back pain
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain | – | Diagnostic Test: Case controlPatients with low back pain |
| No low back pain | – | Diagnostic Test: Case controlNo low back pain patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females between 18 and 65 years old
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- serious illness, current participation in another research study pregnancy previus foot or back surgery
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case controlIs a case-control research | Diagnostic test | Low back pain, No low back pain |
Primary outcome
Hallux dorsal movement range degrees
Time frame: A day, the inclusion day in the study
Goniometer to examinate the range of hallux dorsal movement
1 secondary outcome
Low back pain
Time frame: a day, the inclusion day in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Limitus and Movement, Abnormal, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallux dorsal movement range degrees (time frame: A day, the inclusion day in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.