Mold Making Silicone Toe Separator on Hallux Valgus

Hallux Valgus Clinical Trial

Official title:

Effectiveness of Mold Making Silicone Toe Separator on Hallux Valgus: A Prospective, Randomized Single-Blinded Controlled Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02220881
• Other study ID #: silicone HV
• Status: Unknown status
• Phase: N/A
• First received: January 8, 2014
• Last updated: August 18, 2014
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: August 2014
• Source: Mahidol University
• Contact: Navaporn Chadchavalpanichaya, MD, C.Ped
• Email: drnavaporn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 participants after using mold making silicone toe separator.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

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:
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok-noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance of using Mold Making Silicone Toe Separator	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
Primary	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	Baseline, month 6, month 12
Primary	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	Baseline, month 6, month 12
Secondary	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	Baseline, month 3, month 6, month 9 and month 12