Comparison the effectiveness of customized insole made by foam box impression technique and customized insole made by silicone vacuum bag thermoforming technique in primary metatarsalgia patients: A randomized controlled trial study

Phase 3

Completed

• Conditions: primary metatarsalgia; customized insole; foam box; vacuum bag; pain

• Registration Number: TCTR20200817002
• Lead Sponsor: Prince of Songkla University (PSU)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-05-10
• Study Start: 2020-08-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. 18-65 years old
2. Presented with clinical symptoms compatible with metatarsalgia while walking for at least 2 weeks
3. Able to wear shoes that allow the insertion of an insole for at least 4 hours a day, 5 days a week
5. Able to indicate pain intensity

Exclusion Criteria

1. Foot ulcer
2. Arthritis of the ankle or foot
3. History of foot surgery
4. Peripheral neuropathy
5. Contraindication for Paracetamol usage

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain during walking at baseline, immediate and after treatment 2 weeks visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
walking speed at baseline, immediate and after treatment 2 weeks 10-meter walk test (10MWT)