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

The efficacy of modified total contact orthosis on decreasing pain while walking indoors 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
TCTR20250420002
Enrollment
42
Registered
2025-04-20
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 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,Sham orthosis

Sponsors

Faculty of medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age more than 40 years old 2. Diagnosed as symptomatic posterior tibialis tendon dysfunction grade 1-3 at least 6 weeks 3. An insidious onset of pain along the course of the tendon in medial foot when walking barefoot at home (NRS >5) 4.Always use adaptive outdoor shoes Informed consent 5.participants must regularly use proper external walking shoes (TCO with rigid heel counter shoes such as sneakers) and adhere consistently to their use.

Exclusion criteria

Exclusion criteria: 1.Unable to answer the questionnaire 2.NSAIDs used or stop NSAIDs <2 weeks 3.Always wear sneakers or shoes at home 4.Foot numbness or foot ulcer Gait instability 5.Plan a long trip within 2 weeks

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
To assess patient satisfaction levels with the modified TCO for indoor use at 2 weeks after end of the intervention numeric rating scale,To study the complications associated with the use of modified TCO for indoor use. at 2 weeks after end of the intervention logbook,To evaluate foot functionality using the Foot Functional Index Thai Version at 2 weeks after end of the intervention Questionnaire,To examine compliance in the use of modified TCO for indoor use at 2 weeks after end of the intervention logbook—

Countries

Thailand

Contacts

Public ContactPloypapus Rachatacharoensap

Siriraj hospital

anny.ploypapus@gmail.com024197509

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026