PainNCT01590186
Examination and Treatment of Pain in Front Foot
An observational study of Pain, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore, metatarsalgia can be a sign of excessive load caused by sport activities or at work. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Pain
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2002to Jan 2004
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Examination and treatment of pain in front foot
Who may be able to join
- Examination and treatment of pain in front foot
Who cannot join
- Normal gait
- No pains
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Clinic Aalborg
Aalborg, Northern Jutland
About this study
Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore, metatarsalgia can be a sign of excessive load caused by sport activities or at work. The condition is very common at diabetics and patients with rheumatism.
The purpose of the study is to examine the load under the front foot at health people and patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the best treatment of the flat foot deformity at each patient.
- Conditions
- Pain
- Keywords
- Pain, Front foot, Flat foot, Metatarsalgia
- Medical subject headings
- Pain, Flatfoot, Metatarsalgia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startOct 2002
- Primary completionApr 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Aalborg University
- Responsible party
- Sponsor
- Investigators
- Mogens B Laursen, MD, Principal investigator, Northern Orthopaedic Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590186
- Sponsor's protocol ID
- ON-02-003-OSi
- Status last verified
- Mar 2014
- First submitted
- 5 Jan 2011
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination and Treatment of Pain in Front Foot
- ClinicalTrials.gov ID
- NCT01590186
- Acronym / sponsor ID
- ON-02-003-OSi
- Conditions
- Pain
- Keywords
- Pain, Front foot, Flat foot, Metatarsalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aalborg University
- Study start
- Oct 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 2 May 2012 (estimated)
- 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.
Tibial flat foot deformity is the most common reason for metatarsalgia. Flat foot deformity is a sign of degenerated problems such as weakness in ligament or fractures. Furthermore, metatarsalgia can be a sign of excessive load caused by sport activities or at work. The condition is very common at diabetics and patients with rheumatism.
The purpose of the study is to examine the load under the front foot at health people and patients with metatarsalgia. Furthermore, the researchers aim at being able to assess the best treatment of the flat foot deformity at each patient.
Study design
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Examination and treatment of pain in front foot
Key inclusion criteria (1 listed)
- Examination and treatment of pain in front foot
Key exclusion criteria (2 listed)
- Normal gait
- No pains
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 31 Mar 2014.
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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.
Mogens B Laursen, MD principal investigator
Northern Orthopaedic Division
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 Pain, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 1 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 31 Mar 2014. 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 Denmark. 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.
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 31 Mar 2014.