Mold Making Silicone Toe Separator on Hallux Valgus

August 18, 2014 updated by: Navaporn Chadchavalpanichaya, Mahidol University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Bangkok-noi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Navaporn Chadchavalpanichaya, MD, CPed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Toe separator
OTHER: 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 Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, month 6, month 12
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
Baseline, month 6, month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, month 3, month 6, month 9 and month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, month 3, month 6, month 9 and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (ESTIMATE)

August 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • silicone HV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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