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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

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date August 20, 2014
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2014)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mold Making Silicone Toe Separator on Hallux Valgus
Official Title  ICMJE Effectiveness of Mold Making Silicone Toe Separator on Hallux Valgus: A Prospective, Randomized Single-Blinded Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hallux Valgus
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Mold making silicone toe separator
    The subject in experimental group will use mold making silicone toe separator everyday
    Intervention: Device: Mold making silicone toe separator
  • Observation
    This group will follow the physician instruction of care for the hallux valgus
    Intervention: Other: Observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220881
Other Study ID Numbers  ICMJE silicone HV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Navaporn Chadchavalpanichaya, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mahidol University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP