Low Back PainNCT06240156
A Study on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Pregnant Women
A study testing 3D arch pad design Insole group and flat Insole group in people with Low Back Pain, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The purpose of this study was to understand women with low arched feet, flat feet, or BMI> 29 in the third trimester. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- 3D arch pad design Insole group and flat Insole group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2017to 31 Jul 2019
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to understand and write Chinese
- health and third trimester women
- low arched feet or flat feet or BMI> 29
Who cannot join
- Women with a medical record of back, foot, ankle, knee, musculoskeletal, or neuromuscular trauma or disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Insole Intervention on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Flatfoot Women During the Third Trimester
The purpose of this study was to understand women with low arched feet, flat feet, or BMI> 29 in the third trimester.
Read the detailed description
The purpose of this study was to understand women with low arched feet, flat feet, or BMI> 29 in the third trimester. Compare the intervention measures of different foot pads immediately, two weeks, four weeks, and six weeks after the intervention Immediate and long-term benefits in relief of plantar pressure, dynamic and static balance, and lower back pain.
- Conditions
- Low Back Pain
- Being tested
- 3D arch pad design Insole group, flat Insole group
- Keywords
- pregnancy, gait balance, foot pain, lower back pain
- 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.
3D arch pad design Insole groupOther
3D three-dimensional design that is already available on the market (patent number I315187). Its arch support principle is designed using 3DBS (Three-Dimensional Biomechanics System - 3DBS), which can conform to the user's feet.
flat Insole groupOther
General Insole without any special features
| Study group | Role | What they receive |
|---|---|---|
| 3D arch pad design Insole group | Experimental | This study utilizes a custom-made arch support pad with a 3D three-dimensional design that is already available on the market (patent number I315187). Its arch support principle is designed using 3DBS (Three-Dimensional Biomechanics System - 3DBS), which can conform to the user's feet. In this type, the bottom layer provides an overall shock-absorbing function. Receives: Other: 3D arch pad design Insole group |
| flat Insole group | Placebo comparator | General Insole without any special features Receives: Other: flat Insole group |
What is being measured
The primary outcome is the main question the study is designed to answer.
plantar pressure
The pedar® system, an accurate and reliable pressure distribution measuring system designed to monitor local loads between the foot and the shoe.
Measured: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
static balance
The Timed Up and Go (TUG) test is utilized to assess mobility. It is a simple evaluation that measures the speed at which you can stand up, walk 10 feet, turn around, walk back, and sit down.
Measured: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
foot pain
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
Measured: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
lower back pain
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
Measured: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
daily life disturbance scales
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
Measured: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Mar 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Lin Pan, National Taipei University of Nursing and Health Sciences
- Investigators
- Meei-Ling Gau, PHD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240156
- Sponsor's protocol ID
- 16-S-023-1
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insole Intervention on Plantar Pressure Distribution, Gait Balance and Lower Back Pain in Flatfoot Women During the Third Trimester
- ClinicalTrials.gov ID
- NCT06240156
- Acronym / sponsor ID
- 16-S-023-1
- Conditions
- Low Back Pain
- Keywords
- pregnancy, gait balance, foot pain, lower back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 2 Feb 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 purpose of this study was to understand women with low arched feet, flat feet, or BMI> 29 in the third trimester.
Detailed description
The purpose of this study was to understand women with low arched feet, flat feet, or BMI> 29 in the third trimester. Compare the intervention measures of different foot pads immediately, two weeks, four weeks, and six weeks after the intervention Immediate and long-term benefits in relief of plantar pressure, dynamic and static balance, and lower back pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D arch pad design Insole group | Experimental | Other: 3D arch pad design Insole groupThis study utilizes a custom-made arch support pad with a 3D three-dimensional design that is already available on the market (patent number I315187). Its arch support principle is designed using 3DBS (Three-Dimensional Biomechanics System - 3DBS), which can conform to the user's feet. In this type, the bottom layer provides an overall shock-absorbing function. |
| flat Insole group | Placebo comparator | Other: flat Insole groupGeneral Insole without any special features |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to understand and write Chinese
- health and third trimester women
- low arched feet or flat feet or BMI> 29
Key exclusion criteria (1 listed)
- Women with a medical record of back, foot, ankle, knee, musculoskeletal, or neuromuscular trauma or disease
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 |
|---|---|---|
| 3D arch pad design Insole group3D three-dimensional design that is already available on the market (patent number I315187). Its arch support principle is designed using 3DBS (Three-Dimensional Biomechanics System - 3DBS), which can conform to the user's feet. | Other | 3D arch pad design Insole group |
| flat Insole groupGeneral Insole without any special features | Other | flat Insole group |
Primary outcome
plantar pressure
Time frame: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
The pedar® system, an accurate and reliable pressure distribution measuring system designed to monitor local loads between the foot and the shoe.
static balance
Time frame: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
The Timed Up and Go (TUG) test is utilized to assess mobility. It is a simple evaluation that measures the speed at which you can stand up, walk 10 feet, turn around, walk back, and sit down.
foot pain
Time frame: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
lower back pain
Time frame: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
daily life disturbance scales
Time frame: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
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 2 Feb 2024.
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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.
Meei-Ling Gau, PHD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D arch pad design Insole group and flat Insole group in people with Low Back Pain, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 3 inclusion and 1 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 2 Feb 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
plantar pressure (time frame: footpad intervention measures immediately, two weeks, four weeks, six weeks after intervention). 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?
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 2 Feb 2024.