Rationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:

Not Applicable

Completed

• Conditions: Flexion Contracture of Proximal Interphalangeal Joint; Joint Deformities, Acquired
• Interventions: Device: ETDNO (Elastic Tension digital neoprene orthosis)

• Registration Number: NCT05465603
• Lead Sponsor: Vicenç Punsola Izard

Brief Summary

Introduction: Flexion contracture is one of the most frequent complications in finger trauma. The use of orthoses to obtain the best total end range time (TERT) is the most popular method to treat this pathology . Until now, no orthosis applied for longer than 3 weeks had been able to achieve TERT longer than 12 hours.

Purpose of the study: To assess whether the elastic tension digital neoprene orthosis (ETDNO), using a serial dynamic program, can achieve a better result in ROM and TERT than other orthoses described in the literature.

Methods: analysis of outcomes in a sample of 30 patients with PIP joint flexion contracture treated with the ETDNO and serial dynamic program.

Detailed Description

In this study the researcher will compare the efect of daily TERT treatment on the proximal interphalangeal joint contracture using an ETDNO. The investigator will treat two different groups one with a dose of from 11 to 13 hours of the ETDNO while the other one is treated with a dose of from 20 to 22 hours of daily TERT with the same device. This treatment will last three weeks and will be evalauted the first day, the he first week and the third week. At the end of the study the researcher will quantify the improvement on both groups to know which dailyTERT dose is the best option.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-20
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• PIP flexion contracture

Exclusion Criteria

• more than 6 month of contracture and more than 45º of flexion contracture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
11-13 hours daily TERT intervention	ETDNO (Elastic Tension digital neoprene orthosis)	Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks.
20-22 hours of daily TERT intervention	ETDNO (Elastic Tension digital neoprene orthosis)	Patients that have suffered an injury to the finger causing flexion contracture of the Proximal interphalangeal joint will be treated using an elastic tension neoprene orthosis for a period of 3 weeks.

Primary Outcome Measures

Name	Time	Method
Extension improvement	3 weeks	The degree of extension of the PIP at the end of the treatment compared with the beginning

Trial Locations

Locations (1)

Hand Therapy Barcelona; 🇪🇸 Barcelona, Catalonia, Spain