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Clinical Outcomes between Toe Sleeve versus Toe Separator Treatments: A Randomised Control Trial in 36 Patients with Painful Hallux Valgus

Clinical Outcomes between Toe Sleeve versus Toe Separator Treatments: A Randomised Control Trial in 36 Patients with Painful Hallux Valgus

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200506003
Enrollment
36
Registered
2020-05-06
Start date
2015-06-05
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

Painful hallux valgus bunion pain conservative treatment of hallux valgus hallux valgus painful bunion

Interventions

participants were instructed to wear firm curved shape silicone in the first web space for at least 7 hours a day&#44
5 days a week,participants were instructed to wear tubular silicone with one sided recess to cover the bunion area&#44
under the same advice as the participants in a group of toe separator treatment
Experimental Device,Active Comparator Device
Toe Separator,Toe Sleeve

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patient with a complaint of the painful bunion and intermetatarsal angle over 13 degrees or hallux valgus angle over 20 degrees from the radiograph

Exclusion criteria

Exclusion criteria: osteoarthritis changes of the first metatarsophalangeal joint, history of significant foot injury that affected their normal abilities, neuromuscular disorder, inflammatory joint disease, post infection of the first metatarsophalangeal joint, and history allergic to NSAIDs acetaminophen and silicone.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale 1 and 3 month Questionare,Thai Visual Analog Scale 1 and 3 month Questionare,Visual Analog Scale 1 and 3 month Questionare

Secondary

MeasureTime frame
Compliace 3 month follow up hours/week ,Rescue medication 3 month follow up tabs/week

Countries

Thailand

Contacts

Public ContactSateha Vasaruchapong

Orthopedic department, Ramathibodi Hospital

thuarmd@gmail.com0815433621

Outcome results

None listed

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