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

Sponsor

Vicenç Punsola Izard (Other)

Overall Status

Completed

CT.gov ID

NCT05465603

Collaborator

(none)

Enrollment

Location

Arms

11.4

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Flexion Contracture of Proximal Interphalangeal Joint Joint Deformities, Acquired	Device: ETDNO (Elastic Tension digital neoprene orthosis)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

Rationale for the Use of Elastic Tension Digital Neoprene Orthoses in the Treatment of Proximal Interphalangeal Joint Flexion Contracture: Long Term Results

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 6 months.	Device: ETDNO (Elastic Tension digital neoprene orthosis) A bespoke orthosis created from neoprene.
Active Comparator: 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 6 months.	Device: ETDNO (Elastic Tension digital neoprene orthosis) A bespoke orthosis created from neoprene.

Arm

Intervention/Treatment

Experimental: 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 6 months.

Device: ETDNO (Elastic Tension digital neoprene orthosis)

A bespoke orthosis created from neoprene.

Active Comparator: 11-13 hours daily TERT intervention

Device: ETDNO (Elastic Tension digital neoprene orthosis)

A bespoke orthosis created from neoprene.

Outcome Measures

Primary Outcome Measures

Extension improvement [6 months]
The degree of extension of the PIP at the end of the treatment compared with the beginning

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

PIP flexion contracture

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hand Therapy Barcelona	Barcelona	Catalonia	Spain	08010

Sponsors and Collaborators

Vicenç Punsola Izard

Investigators

Study Director: Josep Maria Potau, PhD, University of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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, Hand Therapy Barcelona

ClinicalTrials.gov Identifier:

NCT05465603

Other Study ID Numbers:

First Posted:

Jul 20, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Contracture

Joint Deformities, Acquired

Study Results

No Results Posted as of Jul 21, 2022