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Mold Making Silicone Toe Separator on Hallux Valgus

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ClinicalTrials.gov Identifier: NCT02220881
Recruitment Status : Unknown
Verified August 2014 by Navaporn Chadchavalpanichaya, Mahidol University.
Recruitment status was:  Recruiting
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Navaporn Chadchavalpanichaya, Mahidol University

Brief 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 participants after using mold making silicone toe separator.

Condition or disease Intervention/treatment Phase
Hallux Valgus Device: Mold making silicone toe separator Other: Observation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Mold Making Silicone Toe Separator on Hallux Valgus: A Prospective, Randomized Single-Blinded Controlled Trial
Study Start Date : November 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion

Arm Intervention/treatment
Experimental: Mold making silicone toe separator
The subject in experimental group will use mold making silicone toe separator everyday
Device: Mold making silicone 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
Other Name: Toe separator

Observation
This group will follow the physician instruction of care for the hallux valgus
Other: Observation
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.
Other Name: Control group




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    To measure the pain score of the hallux by using the numeric rating scale in the 3rd, 6th, 9th and 12th month


Other Outcome Measures:
  1. Compliance of using Mold Making Silicone Toe Separator [ Time Frame: Baseline, month 3, month 6, month 9 and month 12 ]
    To identify the compliance by questionnaire in the 6th and 12th month, and self report (diary)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220881


Contacts
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Contact: Navaporn Chadchavalpanichaya, MD, C.Ped drnavaporn@gmail.com
Contact: Sirirat Sengiad, BSc, MA siriratseng@gmail.com

Locations
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Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkok-noi, Bangkok, Thailand, 10700
Contact: Navaporn Chadchavalpanichaya, MD, C.Ped       drnavaporn@gmail.com   
Contact: Sirirat Sengiad, BSc, MA       siriratseng@gmail.com   
Principal Investigator: Navaporn Chadchavalpanichaya, MD, CPed         
Sponsors and Collaborators
Mahidol University
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Responsible Party: Navaporn Chadchavalpanichaya, Assistance Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02220881    
Other Study ID Numbers: silicone HV
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Navaporn Chadchavalpanichaya, Mahidol University:
Hallux valgus, Mold making silicone toe separator, Toe separator
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired