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Mold Making Silicone Toe Separator on Hallux Valgus

Primary Purpose

Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Mold making silicone toe separator
Observation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Hallux valgus, Mold making silicone toe separator, Toe separator

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mold making silicone toe separator

Observation

Arm Description

The subject in experimental group will use mold making silicone toe separator everyday

This group will follow the physician instruction of care for the hallux valgus

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2014
Last Updated
August 18, 2014
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02220881
Brief Title
Mold Making Silicone Toe Separator on Hallux Valgus
Official Title
Effectiveness of Mold Making Silicone Toe Separator on Hallux Valgus: A Prospective, Randomized Single-Blinded Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Hallux valgus, Mold making silicone toe separator, Toe separator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mold making silicone toe separator
Arm Type
Experimental
Arm Description
The subject in experimental group will use mold making silicone toe separator everyday
Arm Title
Observation
Arm Type
Other
Arm Description
This group will follow the physician instruction of care for the hallux valgus
Intervention Type
Device
Intervention Name(s)
Mold making silicone toe separator
Other Intervention Name(s)
Toe separator
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Observation
Other Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of degree of Hallux valgus angle at month 6 ans month 12
Description
Hallux valgus angle will be measured from the x-ray film taken in standing position with full weight bearing
Time Frame
Baseline, month 6, month 12
Title
Change from baseline of degree of intermetatarsal angle at month 6 ans month 12
Description
Intermetatarsal angle will be measured from the x-ray film taken in standing position with full weight bearing
Time Frame
Baseline, month 6, month 12
Secondary Outcome Measure Information:
Title
Change from baseline in pain score on 11-point Visual Analog Scale at month 3, month 6, month 9 and month 12
Description
To measure the pain score of the hallux by using the numeric rating scale in the 3rd, 6th, 9th and 12th month
Time Frame
Baseline, month 3, month 6, month 9 and month 12
Other Pre-specified Outcome Measures:
Title
Compliance of using Mold Making Silicone Toe Separator
Description
To identify the compliance by questionnaire in the 6th and 12th month, and self report (diary)
Time Frame
Baseline, month 3, month 6, month 9 and month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Navaporn Chadchavalpanichaya, MD, C.Ped
Email
drnavaporn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sirirat Sengiad, BSc, MA
Email
siriratseng@gmail.com
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok-noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Navaporn Chadchavalpanichaya, MD, C.Ped
Email
drnavaporn@gmail.com
First Name & Middle Initial & Last Name & Degree
Sirirat Sengiad, BSc, MA
Email
siriratseng@gmail.com
First Name & Middle Initial & Last Name & Degree
Navaporn Chadchavalpanichaya, MD, CPed

12. IPD Sharing Statement

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Mold Making Silicone Toe Separator on Hallux Valgus

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