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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Flexion Contracture of Proximal Interphalangeal Joint Joint Deformities, Acquired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Patients do not know which dose they are reciving compared to the other group

Study Groups

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20-22 hours of daily TERT intervention

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.

Group Type EXPERIMENTAL

ETDNO (Elastic Tension digital neoprene orthosis)

Intervention Type DEVICE

A bespoke orthosis created from neoprene.

11-13 hours daily TERT intervention

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.

Group Type ACTIVE_COMPARATOR

ETDNO (Elastic Tension digital neoprene orthosis)

Intervention Type DEVICE

A bespoke orthosis created from neoprene.

Interventions

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ETDNO (Elastic Tension digital neoprene orthosis)

A bespoke orthosis created from neoprene.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* PIP flexion contracture

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Vicenç Punsola Izard

Physical Therapist, Certified Hand Therapist in Hand Therapy Barcelona, MSc Gimbernat Universiy , Assistant lecturer at Gimbernat University, PhD Candidate at University of Barcelona

Responsibility Role SPONSOR_INVESTIGATOR