Comparative study of effectiveness between typical total contact insole and plantar fasciitis specific insole using 3D printing technology

Comparative study of effectiveness between typical total contact insole and plantar fasciitis specific insole using 3D printing technology; Prospective and randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004737

Enrollment

Registered

2020-02-14

Start date

2019-02-28

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

None listed

Interventions

Medical Device : Three-dimensional printing used thermoplastic polyurethane (TPU) for the material of insole and the hardness was 58 ± 5 Shore-A. We produced a insole with 3 spikes along the logitudin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Irresponsive to conservative care more than 6 weeks (stretching exercise, rest, ice bag, NSAIDs, orthosis) ? Starting pain >= VAS 5 ? Baseline Roles and Maudsley Score of 3 or 4 ? Patient who agreed the consent

Exclusion criteria

Exclusion criteria: ? Steroid injection within 1 month ? Patient who needs surgery with more than 6 months of symptom ? Infection history to the affected foot or any injection history within 3 months ? Pulselessness to the posterior tibial artery and dorsalis pedis artery ? Ankylosing spondylitis, rheumatoid arthritis, peripheral nerve entrapment syndrome, Achilles tendinitis, bleeding tendency, subtalar arthritis, any dermatologic disease that can induce hindfoot pain ? Calcaneal stress fracture ? Blindness, foreigners that cannot read the consent ? Patient who denies the consent

Design outcomes

Secondary

Measure	Time frame
American Orthopaedic Foot and Ankle (AOFAS) score, Foot and Ankle Outcome Score (FAOS), Karlsson-Peterson (KP) score, Medical Outcomes Study Short Form-36 (SF-36) for quality of life, and Foot Function Index (FFI)	—

Primary

Measure	Time frame
Visual analog scale (VAS) for pain	—

Countries

Korea, Republic of

Contacts

Public ContactDong Woo Shim

Catholic Kwandong University International St.Mary's Hospital

Outcome results