Hallux ValgusNCT02220881
Mold Making Silicone Toe Separator on Hallux Valgus
A study testing Mold making silicone toe separator and Observation in people with Hallux Valgus, run by Mahidol University at 1 site in Thailand.
Trial summary
The primary objective of this study is to investigate the effectiveness of mold making silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to determine the compliance of mold making silicone toe separator, the change in pain level and, including, the satisfaction of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Mold making silicone toe separator and Observation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2013to May 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years of age
- Presence of hallux valgus deformity in moderate level, if the condition presents in both side, the one with greater angle will be selected
- Never use hallux valgus strap or toes separator before
Who cannot join
- Presence of hallux rigidus and hallux limitus
- Presence of acute hallux inflammation
- Experience the use hallux valgus strap or toes separator in a past year
- Experience the allergy to silicone
Trial locations and contacts
1 site in 1 country.
Navaporn Chadchavalpanichaya, MD, C.Ped contact
Sirirat Sengiad, BSc, MA contact
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Navaporn Chadchavalpanichaya, MD, C.Ped, drnavaporn@gmail.com
Sirirat Sengiad, BSc, MA, siriratseng@gmail.com
About this study
Official title: Effectiveness of Mold Making Silicone Toe Separator on Hallux Valgus: A Prospective, Randomized Single-Blinded Controlled Trial
The primary objective of this study is to investigate the effectiveness of mold making silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to determine the compliance of mold making silicone toe separator, the change in pain level and, including, the satisfaction of the participants after using mold making silicone toe separator.
Read the detailed description
Study Protocol, Data collection
Ninety recruited sample is the patient come to the foot clinic, Siriraj Hospital with the age over eighteen years old, presence of hallux valgus deformity in moderate level (without the condition of hallux rigidus), and never use hallux valgus strap or toes separator before.
The sample is given a physical assessment by physician and is asked to fill in a self-administered questionnaire which composes of general information, the foot problem information and the impact of deformity to patients function information. General information section requires the detail regarding age, genders, and the average walking hours. Foot problem information section composes of side, duration of hallux valgus and family history. Impacts of the hallux valgus deformity section includes walking problem, shoes-fitting problem, working problem, and daily activities problem, were recorded by using a numeric rating scale from 0 to 10; 0 refers as no problem and 10 refers as the worst problem. The sample then will be taken the radiograph of the feet in order to evaluate the degree of hallux valgus angle and intermetatarsal angle.
After the completion of assessment, the sample is randomly divided into 2 groups; control and experimental group by using computer program.
- Control group receives the recommendation of use the proper shoes without determination of current drug use
- Experimental group receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
The follow up activity is on every 3rd, 6th, 9th and 12th of the study period in both groups by using questionnaire; pain score (NRS), satisfaction of using the custom-made mold making silicone toe separator (NRS) and report of complication. In the 6th and 12th month, the progress evaluation on hallux valgus and intermetatarsal angle is done by radiograph. The angle then is recorded by mean of the three values.
Descriptive statistics; mean, standard deviation or interquartile range, will be used to identify the demographic data of the participant and compliance of device usage. Analytical statistics; Unpaired t-test or Mann Whitney U test will be used for determining the average device usage time, pain score, and satisfaction of the participants after using mold making silicone toe separator.
- Conditions
- Hallux Valgus
- Being tested
- Mold making silicone toe separator, Observation
- Keywords
- Hallux valgus, Mold making silicone toe separator, Toe separator
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mold making silicone toe separatorDevice
Also called Toe separator
Each subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
ObservationOther
Also called Control group
The participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month.
| Study group | Role | What they receive |
|---|---|---|
| Mold making silicone toe separator | Experimental | The subject in experimental group will use mold making silicone toe separator everyday Receives: Device: Mold making silicone toe separator |
| Observation | Other | This group will follow the physician instruction of care for the hallux valgus Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of degree of Hallux valgus angle at month 6 ans month 12
Hallux valgus angle will be measured from the x-ray film taken in standing position with full weight bearing
Measured: Baseline, month 6, month 12
Change from baseline of degree of intermetatarsal angle at month 6 ans month 12
Intermetatarsal angle will be measured from the x-ray film taken in standing position with full weight bearing
Measured: Baseline, month 6, month 12
Secondary outcomes (1)
Change from baseline in pain score on 11-point Visual Analog Scale at month 3, month 6, month 9 and month 12
To measure the pain score of the hallux by using the numeric rating scale in the 3rd, 6th, 9th and 12th month
Measured: Baseline, month 3, month 6, month 9 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navaporn Chadchavalpanichaya, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220881
- Sponsor's protocol ID
- silicone HV
- Status last verified
- Aug 2014
- First submitted
- 8 Jan 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mold Making Silicone Toe Separator on Hallux Valgus: A Prospective, Randomized Single-Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT02220881
- Acronym / sponsor ID
- silicone HV
- Conditions
- Hallux Valgus
- Keywords
- Hallux valgus, Mold making silicone toe separator, Toe separator
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 20 Aug 2014 (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.
The primary objective of this study is to investigate the effectiveness of mold making silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to determine the compliance of mold making silicone toe separator, the change in pain level and, including, the satisfaction of the participants after using mold making silicone toe separator.
Detailed description
Study Protocol, Data collection
Ninety recruited sample is the patient come to the foot clinic, Siriraj Hospital with the age over eighteen years old, presence of hallux valgus deformity in moderate level (without the condition of hallux rigidus), and never use hallux valgus strap or toes separator before.
The sample is given a physical assessment by physician and is asked to fill in a self-administered questionnaire which composes of general information, the foot problem information and the impact of deformity to patients function information. General information section requires the detail regarding age, genders, and the average walking hours. Foot problem information section composes of side, duration of hallux valgus and family history. Impacts of the hallux valgus deformity section includes walking problem, shoes-fitting problem, working problem, and daily activities problem, were recorded by using a numeric rating scale from 0 to 10; 0 refers as no problem and 10 refers as the worst problem. The sample then will be taken the radiograph of the feet in order to evaluate the degree of hallux valgus angle and intermetatarsal angle.
After the completion of assessment, the sample is randomly divided into 2 groups; control and experimental group by using computer program.
- Control group receives the recommendation of use the proper shoes without determination of current drug use
- Experimental group receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
The follow up activity is on every 3rd, 6th, 9th and 12th of the study period in both groups by using questionnaire; pain score (NRS), satisfaction of using the custom-made mold making silicone toe separator (NRS) and report of complication. In the 6th and 12th month, the progress evaluation on hallux valgus and intermetatarsal angle is done by radiograph. The angle then is recorded by mean of the three values.
Descriptive statistics; mean, standard deviation or interquartile range, will be used to identify the demographic data of the participant and compliance of device usage. Analytical statistics; Unpaired t-test or Mann Whitney U test will be used for determining the average device usage time, pain score, and satisfaction of the participants after using mold making silicone toe separator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mold making silicone toe separator | Experimental | Device: Mold making silicone toe separatorThe subject in experimental group will use mold making silicone toe separator everyday |
| Observation | Other | Other: ObservationThis group will follow the physician instruction of care for the hallux valgus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than 18 years of age
- Presence of hallux valgus deformity in moderate level, if the condition presents in both side, the one with greater angle will be selected
- Never use hallux valgus strap or toes separator before
Key exclusion criteria (4 listed)
- Presence of hallux rigidus and hallux limitus
- Presence of acute hallux inflammation
- Experience the use hallux valgus strap or toes separator in a past year
- Experience the allergy to silicone
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 |
|---|---|---|
| Mold making silicone toe separatorAlso: Toe separatorEach subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use | Device | Mold making silicone toe separator |
| ObservationAlso: Control groupThe participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month. | Other | Observation |
Primary outcome
Change from baseline of degree of Hallux valgus angle at month 6 ans month 12
Time frame: Baseline, month 6, month 12
Hallux valgus angle will be measured from the x-ray film taken in standing position with full weight bearing
Change from baseline of degree of intermetatarsal angle at month 6 ans month 12
Time frame: Baseline, month 6, month 12
Intermetatarsal angle will be measured from the x-ray film taken in standing position with full weight bearing
1 secondary outcome
Change from baseline in pain score on 11-point Visual Analog Scale at month 3, month 6, month 9 and month 12
Time frame: Baseline, month 3, month 6, month 9 and month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
Navaporn Chadchavalpanichaya, MD, C.Ped contact
Sirirat Sengiad, BSc, MA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mold making silicone toe separator and Observation in people with Hallux Valgus, run by Mahidol University at 1 site in Thailand.
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 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 20 Aug 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 Thailand. 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?
Contact Navaporn Chadchavalpanichaya, MD, C.Ped (drnavaporn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of degree of Hallux valgus angle at month 6 ans month 12 (time frame: Baseline, month 6, month 12). The study lists 2 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 20 Aug 2014.