NCT04043780

Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome

Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome: a Multicentric Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universidad de Zaragoza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicentric randomized controlled trial has been designed to study the effects of a decompression prototype splint on symptoms, functional capacity and nerve conduction studies in patients with carpal tunnel syndrome.

Detailed description

A decompression prototype splint was designed to simulate an manual mobilization that is able to increase the CSA of the carpal tunnel and the median nerve in cadavers. These changes are important because they may relate to the decrease in CTS symptoms. Patients with mild or moderate carpal tunnel syndrome will be selected for the trial. They will be randomized in 2 groups. One group will wear an standard splint for carpal tunnel syndrome and the other the decompression prototype splint.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
DEVICE	Decompression prototype splint for carpal tunnel syndrome	This group will wear during 6 weeks a decompression prototype splint. They we be informed to wear it as long as possible during the 6 weeks.
DEVICE	Standard splint for carpal tunnel syndrome	This group will wear during 6 weeks a standard splint. They we be informed to wear it as long as possible during the 6 weeks.

Timeline

• Start date: 2019-09-24
• Primary completion: 2020-03-01
• Completion: 2020-09-01
• First posted: 2019-08-02
• Last updated: 2020-11-04

Locations

1 site across 1 country: Spain