Clinical Trial: Mold Making Silicone Toe Separator on Hallux Valgus

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary:

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
Sponsor: Mahidol University

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome: 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: Same as current

Information By: Mahidol University

Dates:
Date Received: January 8, 2014
Date Started: November 2013
Date Completion: May 2016
Last Updated: August 18, 2014
Last Verified: August 2014