The efficacy of modified total contact orthosis on decreasing pain in patients with posterior tibial tendon dysfunction, A prospective, randomized double-blinded controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20231026005

Enrollment

Registered

2023-10-26

Start date

2023-09-20

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

Posterior tibial tendon dysfunction is a painful condition that affects the foot and ankle. It can affect your ability to walk or perform certain lower-body movements. PTTD can be treated through nonsurgical such as TCO wearing in shoes. Posterior tibial tendon dysfunction, PTTD, flatfoot, Total contact foot orthosis, TCO, insole

Interventions

A modified TCO looks like a slipper made of a TCO, with an upper part made of soft leather, that covers along medial arch of foot and an outsole made of non-slip foam. ,The sham orthosis looks exactl

Experimental Device,Sham Comparator Device

Modified total contact orthosis to reduce pain severity of patients with PTTD during walking at home,Modified sham orthosis to reduce pain severity of patients with PTTD during walking at home

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Age more than 40 years old Diagnosed as symptomatic posterior tibialis tendon dysfunction grade 1-3 at least 6 weeks An insidious onset of pain along the course of the tendon in medial foot when walking barefoot at home (NRS >5) Always use adaptive outdoor shoes Informed consent

Exclusion criteria

Exclusion criteria: Unable to answer the questionnaire NSAIDs used or stop NSAIDs <2 weeks Always wear sneakers or shoes at home Foot numbness or foot ulcer Gait instability Plan a long trip within 2 weeks

Design outcomes

Primary

Measure	Time frame
To study the effectiveness of modified TCO for reducing pain in patients walking indoors with PTTD at 2 weeks after end of the intervention numeric rating scale	—

Secondary

Measure	Time frame
To assess patient satisfaction levels with the modified TCO for indoor use 2 numeric rating scale	—

Countries

Thailand

Contacts

Public ContactPloypapus Rachatacharoensap

Siriraj hospital

anny.ploypapus@gmail.com024197509

Outcome results

None listed

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