Back PainNCT05909345
Examination of Foot Posture's Change on Balance in Different Disorders
An observational study of Back Pain and Knee Osteoarthritis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Foot; It is a terminal joint that opposes external resistance in the lower kinetic chain. It plays a primary role in weight transfer and ground response between the body and the ground. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Back Pain, Knee Osteoarthritis
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 9 Jul 2024
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To evaluate the foot postures and balances of individuals with knee osteoarthritis and nonspecific low back pain.
Who may be able to join
- Being between the ages of 45 - 65,
- Volunteer. Exclusion criteria;
- Having a musculoskeletal or neuromuscular disease that limits mobility,
- Presence of lower extremity sequelae,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol hospital
Istanbul, Istanbul Avrupa Kitasi, 34353
About this study
Foot; It is a terminal joint that opposes external resistance in the lower kinetic chain. It plays a primary role in weight transfer and ground response between the body and the ground.
Read the detailed description
To investigate the extent to which foot posture affects balance and foot function in different disease groups. The amount of studies examining the effect of the postural structure of the foot and balance seen in different disease groups in the literature is insufficient.
- Conditions
- Back Pain, Knee Osteoarthritis
- Keywords
- back pain, Knee Osteoarthritis
- Medical subject headings
- Back Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Not described | |
| Nonspecific Low Back Pain | Not described | |
| healthy peers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop Test
The distance between the tubercle of the navicular, which is the attachment of the tibialis posterior muscle, and the ground, was measured in this position by asking each participant to give full weight to their bare feet. The distance between the navicular tubercle and the ground was measured without any weight on the feet in the subtalar neutral position. The difference between this distance and the amount of navicular height was recorded as navicular drop (millimetres).
Measured: one day
Foot Posture Index
Foot Posture consists of palpation of 6 regions. Each criterion is evaluated between -2 and +2 and this result is noted. Positive values indicate pronation, negative values indicate supination.
Measured: one day
Y Balance Test
The leg lengths of all individuals are measured bilaterally. While measuring, individuals are asked to lie in their anterior, posteromedial and posterolateral directions. Each of the participants is informed before the measurement. Measurements were made in both legs and will be repeated 3 times. When calculating the total score, the values in centimeters of the 3 directions are added. Divide by the product of the length of the leg by 3 and multiply the result by 100 to reach the percentile.
Measured: one day
Secondary outcomes (2)
Oswestry Low Back Pain Disability Questionnaire
It includes 1 item about pain and 9 items about activities of daily living. Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, scores are summed up and a high score means loss of disability.
Measured: one day
Western Ontario and MacMaster (WOMAC)
Western Ontario and MacMaster (WOMAC) is evaluated by dividing it into three groups as pain, stiffness and physical function, consisting of a total of 24 questions used in the evaluation of lower extremity OA. The total WOMAC score is obtained by summing up all the values by evaluating these three titles separately. At the end of the questionnaire, scores are summed up and a high score means loss of disability.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Jun 2023
- Primary completion15 Jun 2023
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back 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
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909345
- Sponsor's protocol ID
- E-85646034-604.02.02-60261
- Status last verified
- Jul 2024
- First submitted
- 9 Jun 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sporndly-Nees S, Dasberg B, Nielsen RO, Boesen MI, Langberg H. The navicular position test - a reliable measure of the navicular bone position during rest and loading. Int J Sports Phys Ther. 2011 Sep;6(3):199-205.
PubMed 21904698
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Foot Posture's Change on Balance in Different Disorders
- ClinicalTrials.gov ID
- NCT05909345
- Acronym / sponsor ID
- E-85646034-604.02.02-60261
- Conditions
- Back Pain, Knee Osteoarthritis
- Keywords
- back pain, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 18 Jun 2023 (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; It is a terminal joint that opposes external resistance in the lower kinetic chain. It plays a primary role in weight transfer and ground response between the body and the ground.
Detailed description
To investigate the extent to which foot posture affects balance and foot function in different disease groups. The amount of studies examining the effect of the postural structure of the foot and balance seen in different disease groups in the literature is insufficient.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | – | – |
| Nonspecific Low Back Pain | – | – |
| healthy peers | – | – |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To evaluate the foot postures and balances of individuals with knee osteoarthritis and nonspecific low back pain.
Key inclusion criteria (4 listed)
- Being between the ages of 45 - 65,
- Volunteer. Exclusion criteria;
- Having a musculoskeletal or neuromuscular disease that limits mobility,
- Presence of lower extremity sequelae,
Key exclusion criteria (0 listed)
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
Navicular Drop Test
Time frame: one day
The distance between the tubercle of the navicular, which is the attachment of the tibialis posterior muscle, and the ground, was measured in this position by asking each participant to give full weight to their bare feet. The distance between the navicular tubercle and the ground was measured without any weight on the feet in the subtalar neutral position. The difference between this distance and the amount of navicular height was recorded as navicular drop (millimetres).
Foot Posture Index
Time frame: one day
Foot Posture consists of palpation of 6 regions. Each criterion is evaluated between -2 and +2 and this result is noted. Positive values indicate pronation, negative values indicate supination.
Y Balance Test
Time frame: one day
The leg lengths of all individuals are measured bilaterally. While measuring, individuals are asked to lie in their anterior, posteromedial and posterolateral directions. Each of the participants is informed before the measurement. Measurements were made in both legs and will be repeated 3 times. When calculating the total score, the values in centimeters of the 3 directions are added. Divide by the product of the length of the leg by 3 and multiply the result by 100 to reach the percentile.
2 secondary outcomes
Oswestry Low Back Pain Disability Questionnaire
Time frame: one day
Western Ontario and MacMaster (WOMAC)
Time frame: one day
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 11 Jul 2024.
- Background: PubMed 21904698Sporndly-Nees S, Dasberg B, Nielsen RO, Boesen MI, Langberg H. The navicular position test - a reliable measure of the navicular bone position during rest and loading. Int J Sports Phys Ther. 2011 Sep;6(3):199-205.
- 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 Back Pain and Knee Osteoarthritis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 0 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 11 Jul 2024. 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 Turkey (Türkiye). 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?
Navicular Drop Test (time frame: one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909345, which also lists 1 linked publication.
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 11 Jul 2024.