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Comparative study of the efficacy of proximal interphalangeal joint splint for trigger finger treatment between P.V.C plastic proximal interphalangeal joint splint and Custom-made thermoplastic proximal interphalangeal joint splint. A randomized controlled non-inferiority trial study

Comparative study of the efficacy of proximal interphalangeal joint splint for trigger finger treatment between P.V.C plastic proximal interphalangeal joint splint and Custom-made thermoplastic proximal interphalangeal joint splint. A randomized controlled non-inferiority trial study

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241030003
Enrollment
86
Registered
2024-10-30
Start date
2024-10-30
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

Trigger finger Trigger finger splint P.I.P splint thermoplastic splint PVC splint

Interventions

Participants allocated to this group will be assigned to wear a P.I.P. splint made from PVC plastic for at least 18 hours per day for 6 weeks (including nighttime use). Participants are allowed to rem
Experimental Device,Active Comparator Device
Home-made splint,Thermoplastic splint

Sponsors

Ratchadapisek Research Funds
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.18 year-old or older 2.Who has been diagnosed with trigger finger based on clinical symptoms 3.Who has been diagnosed with single trigger finger 4.Who has been diagnosed with trigger finger stage II-V 5.Who has never been treated with steroid injection or surgery before 6.Can follow as appointment for at least 6 weeks interval

Exclusion criteria

Exclusion criteria: 1.Who has been diagnosed with trigger thumb 2.Who has been diagnosed with carpal tunnel syndrome(CTS) based on clinical symptoms and 3.provocative test 4.Who has been diagnosed with De querveins tenosynovitis on same side of hand 5.Who has been diagnosed with Dupuytrens contracture 6.Who has been diagnosed with Diabetes mellitus 7.Who cant answer the questionnaire 8.Who refuse to join the study 9.Who has abrasion, open wound or chronic wound on the finger that have to wear a splint

Design outcomes

Primary

MeasureTime frame
Quick-DASH score Before and 6 weeks after intervention Measure disability of upper extremity by using Quick-DASH questionnaire

Secondary

MeasureTime frame
Visual Analog Scale Before, 3 weeks and 6 weeks after intervention Pain scores are evaluated on a scale from 0 (no pain) to 10 (most painful).,Number of triggering events in ten active fist (NTTAF) Before, 3 weeks and 6 weeks after intervention Count the number of triggering events of trigger finger during active fist clenching of the affected hand.,Stage of trigger finger Before and 6 weeks after intervention Stage of trigger finger Patel and Bassini , range from 1 to 6,Patient satisfaction Before and 6 weeks after intervention Patient satisfaction by scoring: Excellent, Good, Fair, Poor, Very poor

Countries

Thailand

Contacts

Public ContactJiratchawit Thitisittichoke

Department of Orthopaedics, Faculty of Medicine, Chulalongkorn University

jiratchawit.thi@chulahospital.org022564510

Outcome results

None listed

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