OrthosislumbosacralNCT06289088
The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance
A study testing First Intervention, Second Intervention and Third Intervention in people with Orthosis and Low Back Pain, Postural, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthosis, Low Back Pain, Postural
- What is being tested?
- First Intervention, Second Intervention and Third Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 4 May 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65,
- One or more recurrent low back pain during the last 12 months,-At least 6 points on the Oswestry Disability Index,
- Negative straight leg raising test result,
- Not having any lower extremity injuries in the last 6 months,
- No history of recent trauma or infection
Who cannot join
- Neurological symptoms due to nerve root compression
- One-sided leg pain more severe than lower back pain, pain in feet and toes shooting pain, numbness in the same area, paresthesia,
- Disease that causes neurological sequelae (stroke, traumatic brain injury, Parkinson's, Those who have had it (such as multiple sclerosis),
- Presence of malignancy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance in Individuals With Low Back Pain
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain.
Read the detailed description
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. Thirty male and female volunteers between the ages of 18-65 who came to Istanbul Medipol University Prosthesis Orthotics Center and experienced low back pain were included in the study.
The study will be designed as Crossover. The study consists of three methods and a single group, which are orthosis-free, worn by a person with low back pain, and adapted by a prosthetist orthotist. Following both orthosis insertion methods, pain severity will be measured with Visual Analogue Scale (VAS) and comfort level was measured with Orthosis Comfort Score. They will be asked to wait for 30 minutes with orthosis, and then the pain severity and comfort level were measured again. Y Balance Test (YBT) and Functional Reach Test (FRT) will be used for dynamic balance. Plantar pressure and static balance will be analyzed with pedobarography device. Static Pressure and stabilometric data will be found.
- Conditions
- Orthosis, Low Back Pain, Postural
- Being tested
- First Intervention, Second Intervention, Third Intervention
- Keywords
- Low back pain, lumbosacral orthosis, orthosis adjustment, postural control, plantar pressure, balance
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First InterventionOther
Firstly, For individuals with low back pain, all measurements will be evaluated without wearing any orthosis. The waist circumference of individuals with low back pain will be measured and the orthosis was adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, the measurements will be repeated. Then, the person will be asked to wear the orthosis without any intervention.
Second InterventionOther
Firstly, The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, the person will be asked to wear the orthosis without any intervention and the outcome measurements will be repeated. After waiting with the orthosis for half an hour, all measurements will be evaluated without wearing any orthosis.
Third InterventionOther
Firstly, the person will be asked to wear the orthosis without any intervention and the outcome measurements will be done. The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, all measurements will be evaluated without wearing any orthosis. Lastly, The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotis. After waiting with the orthosis for half an hour, all measurements will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| First Intervention | Experimental | The application will be done sequentially: without orthosis, with adaptation and with orthosis. Receives: Other: First Intervention |
| Second Intervention | Experimental | The application will be done sequentially: with adaptation, with orthosis and without orthosis Receives: Other: Second Intervention |
| Third Intervention | Experimental | The application will be done sequentially: with orthosis, without orthosis, and with adaptation Receives: Other: Third Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson[1]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous; their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised
Measured: 5 minutes
Orthosis comfort score
An orthosis comfort score, which is valid and reliable and developed from the socket comfort score, will be used to evaluate comfort. The score measures the comfort felt by the patient between values of 0 and 10. "How would you rate the comfort of the orthosis?" They are expected to answer the question as 0 is the most uncomfortable orthosis and 10 is the most comfortable orthosis.
Measured: 10 minutes
Functional Reach Test (FRT)
Functional Reach Test (FRT) is a assessment tool for ascertaining dynamic balance in in simple task. In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. This information is correlated with risk of falling.
Measured: 5 minutes
Pedobarographic evaluation
Foot plantar pressure distribution (static pedobarographic) analyzes and postural stability parameters will be performed through a computer-aided data collection and display system. Sensor Medica (Rome, Italy) Pedobarography Device, which has a pressure-sensitive platform connected to the computer and a software system that records and analyzes the data. Measurements will be made for individuals with low back pain.
Measured: 5 minutes
Y balance test
Y Balance Test, strength, flexibility, filter control and proprioception.Taking a one-legged stand is a reliable test for exercising dynamic balance. Three-way reach carries out operations of individuals of individuals. They were asked to lie down to the last magnification without disrupting the alignment with the side to be tested and to return to the center after each stretch. After trial access, access was requested in three directions. Measurements are fired with 10-second breaks between trials and 20-second breaks between directions. The reach made after 3 reach attempts for each direction was measured and taken into the recording area, and the test was used in the overall performance analysis.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start4 Mar 2024
- Primary completion4 May 2024 (estimated)
- Study completion4 May 2024 (estimated)
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 OrthosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single group, crossover study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yilmaz menek, Istanbul Medipol University Hospital
- Investigators
- MERVE YILMAZ MENEK, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289088
- Sponsor's protocol ID
- E-10840098-772.02-4659
- Acronym
- lumbosacral
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Azadinia F, Ebrahimi-Takamjani I, Kamyab M, Asgari M, Parnianpour M. Immediate Effects of Lumbosacral Orthosis on Postural Stability in Patients with Low Back Pain: A Preliminary Study. Arch Bone Jt Surg. 2019 Jul;7(4):360-366.
PubMed 31448314
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance in Individuals With Low Back Pain
- ClinicalTrials.gov ID
- NCT06289088
- Acronym / sponsor ID
- lumbosacral / E-10840098-772.02-4659
- Conditions
- Orthosis, Low Back Pain, Postural
- Keywords
- Low back pain, lumbosacral orthosis, orthosis adjustment, postural control, plantar pressure, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 4 May 2024 (estimated)
- Study completion
- 4 May 2024 (estimated)
- First posted
- 1 Mar 2024 (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.
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain.
Detailed description
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. Thirty male and female volunteers between the ages of 18-65 who came to Istanbul Medipol University Prosthesis Orthotics Center and experienced low back pain were included in the study.
The study will be designed as Crossover. The study consists of three methods and a single group, which are orthosis-free, worn by a person with low back pain, and adapted by a prosthetist orthotist. Following both orthosis insertion methods, pain severity will be measured with Visual Analogue Scale (VAS) and comfort level was measured with Orthosis Comfort Score. They will be asked to wait for 30 minutes with orthosis, and then the pain severity and comfort level were measured again. Y Balance Test (YBT) and Functional Reach Test (FRT) will be used for dynamic balance. Plantar pressure and static balance will be analyzed with pedobarography device. Static Pressure and stabilometric data will be found.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single group, crossover study
| Arm | Type | Receives |
|---|---|---|
| First Intervention | Experimental | Other: First InterventionThe application will be done sequentially: without orthosis, with adaptation and with orthosis. |
| Second Intervention | Experimental | Other: Second InterventionThe application will be done sequentially: with adaptation, with orthosis and without orthosis |
| Third Intervention | Experimental | Other: Third InterventionThe application will be done sequentially: with orthosis, without orthosis, and with adaptation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 18-65,
- One or more recurrent low back pain during the last 12 months,-At least 6 points on the Oswestry Disability Index,
- Negative straight leg raising test result,
- Not having any lower extremity injuries in the last 6 months,
- No history of recent trauma or infection
Key exclusion criteria (4 listed)
- Neurological symptoms due to nerve root compression
- One-sided leg pain more severe than lower back pain, pain in feet and toes shooting pain, numbness in the same area, paresthesia,
- Disease that causes neurological sequelae (stroke, traumatic brain injury, Parkinson's, Those who have had it (such as multiple sclerosis),
- Presence of malignancy,
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 |
|---|---|---|
| First InterventionFirstly, For individuals with low back pain, all measurements will be evaluated without wearing any orthosis. The waist circumference of individuals with low back pain will be measured and the orthosis was adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, the measurements will be repeated. Then, the person will be asked to wear the orthosis without any intervention. | Other | First Intervention |
| Second InterventionFirstly, The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, the person will be asked to wear the orthosis without any intervention and the outcome measurements will be repeated. After waiting with the orthosis for half an hour, all measurements will be evaluated without wearing any orthosis. | Other | Second Intervention |
| Third InterventionFirstly, the person will be asked to wear the orthosis without any intervention and the outcome measurements will be done. The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, all measurements will be evaluated without wearing any orthosis. Lastly, The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotis. After waiting with the orthosis for half an hour, all measurements will be evaluated. | Other | Third Intervention |
Primary outcome
Visual Analog scale
Time frame: 5 minutes
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson[1]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective, this spectrum appears continuous; their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised
Orthosis comfort score
Time frame: 10 minutes
An orthosis comfort score, which is valid and reliable and developed from the socket comfort score, will be used to evaluate comfort. The score measures the comfort felt by the patient between values of 0 and 10. "How would you rate the comfort of the orthosis?" They are expected to answer the question as 0 is the most uncomfortable orthosis and 10 is the most comfortable orthosis.
Functional Reach Test (FRT)
Time frame: 5 minutes
Functional Reach Test (FRT) is a assessment tool for ascertaining dynamic balance in in simple task. In standing, measures the distance between the length of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support. This information is correlated with risk of falling.
Pedobarographic evaluation
Time frame: 5 minutes
Foot plantar pressure distribution (static pedobarographic) analyzes and postural stability parameters will be performed through a computer-aided data collection and display system. Sensor Medica (Rome, Italy) Pedobarography Device, which has a pressure-sensitive platform connected to the computer and a software system that records and analyzes the data. Measurements will be made for individuals with low back pain.
Y balance test
Time frame: 15 minutes
Y Balance Test, strength, flexibility, filter control and proprioception.Taking a one-legged stand is a reliable test for exercising dynamic balance. Three-way reach carries out operations of individuals of individuals. They were asked to lie down to the last magnification without disrupting the alignment with the side to be tested and to return to the center after each stretch. After trial access, access was requested in three directions. Measurements are fired with 10-second breaks between trials and 20-second breaks between directions. The reach made after 3 reach attempts for each direction was measured and taken into the recording area, and the test was used in the overall performance analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Results publication: PubMed 31448314Azadinia F, Ebrahimi-Takamjani I, Kamyab M, Asgari M, Parnianpour M. Immediate Effects of Lumbosacral Orthosis on Postural Stability in Patients with Low Back Pain: A Preliminary Study. Arch Bone Jt Surg. 2019 Jul;7(4):360-366.
- Immediate Effects of Lumbosacral Orthosis on Postural Stability in Patients with Low Back Pain: A Preliminary StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
MERVE YILMAZ MENEK, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Intervention, Second Intervention and Third Intervention in people with Orthosis and Low Back Pain, Postural, 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Mar 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?
Results are not available in the source record.
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?
Visual Analog scale (time frame: 5 minutes). The study lists 5 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 NCT06289088, 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 19 Mar 2024.