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

NCT05465603 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexion Contracture of Proximal Interphalangeal Joint; Joint Deformities, Acquired

Outcome Measures

Primary Outcomes (1)

• Extension improvement

  The degree of extension of the PIP at the end of the treatment compared with the beginning

  3 weeks

Study Arms (2)

20-22 hours of daily TERT intervention

EXPERIMENTAL

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.

Device: ETDNO (Elastic Tension digital neoprene orthosis)

11-13 hours daily TERT intervention

ACTIVE COMPARATOR

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.

Device: ETDNO (Elastic Tension digital neoprene orthosis)

Interventions

ETDNO (Elastic Tension digital neoprene orthosis) DEVICE

A bespoke orthosis created from neoprene.

11-13 hours daily TERT intervention; 20-22 hours of daily TERT intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PIP flexion contracture

You may not qualify if:

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

Sponsors & Collaborators

• Vicenç Punsola Izard: lead

Study Sites (1)

Hand Therapy Barcelona

Barcelona, Catalonia, 08010, Spain

Location

MeSH Terms

Conditions

Joint Deformities, Acquired

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Vicenç Punsola-Izard

  Hand Therapy Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients do not know which dose they are reciving compared to the other group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapist, Certified Hand Therapist in Hand Therapy Barcelona, MSc Gimbernat Universiy , Assistant lecturer at Gimbernat University, PhD Candidate at University of Barcelona

Study Record Dates

• First Submitted: July 17, 2022
• First Posted: July 20, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 14, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)