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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200817002
Enrollment
Unknown
Registered
2020-08-17
Start date
2019-02-14
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary metatarsalgia primary metatarsalgia customized insole foam box vacuum bag pain

Interventions

Experimental Device,Active Comparator Device
silicone vacuum bag thermoforming technique,foam box impression technique
customized insole made by silicone vacuum bag thermoforming technique,customized insole made by foam box impression technique

Sponsors

Prince of Songkla University (PSU)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
pain during walking at baseline, immediate and after treatment 2 weeks visual analogue scale (VAS)

Secondary

MeasureTime frame
walking speed at baseline, immediate and after treatment 2 weeks 10-meter walk test (10MWT)

Countries

Thailand

Contacts

Public ContactPongphon Chuchuen

Rehabilitation Medicine Division, Prince of Songkla University

pongphon.c@hotmail.com+66869713352

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026