Back to resultsRationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:
Primary Purpose
Flexion Contracture of Proximal Interphalangeal Joint, Joint Deformities, Acquired
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ETDNO (Elastic Tension digital neoprene orthosis)
Sponsored by
About this trial
This is an interventional treatment trial for Flexion Contracture of Proximal Interphalangeal Joint
Eligibility Criteria
Inclusion Criteria:
- PIP flexion contracture
Exclusion Criteria:
- more than 6 month of contracture and more than 45º of flexion contracture
Sites / Locations
- Hand Therapy Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
20-22 hours of daily TERT intervention
11-13 hours daily TERT intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Extension improvement
The degree of extension of the PIP at the end of the treatment compared with the beginning
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05465603
Brief Title
Rationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:
Official Title
Rationale for the Use of Elastic Tension Digital Neoprene Orthoses in the Treatment of Proximal Interphalangeal Joint Flexion Contracture: Long Term Results
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vicenç Punsola Izard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexion Contracture of Proximal Interphalangeal Joint, Joint Deformities, Acquired
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients do not know which dose they are reciving compared to the other group
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20-22 hours of daily TERT intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
11-13 hours daily TERT intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ETDNO (Elastic Tension digital neoprene orthosis)
Intervention Description
A bespoke orthosis created from neoprene.
Primary Outcome Measure Information:
Title
Extension improvement
Description
The degree of extension of the PIP at the end of the treatment compared with the beginning
Time Frame
3 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PIP flexion contracture
Exclusion Criteria:
more than 6 month of contracture and more than 45º of flexion contracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicenç Punsola-Izard
Organizational Affiliation
Hand Therapy Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hand Therapy Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
will be available in the papers published
Learn more about this trial
Rationale and Analysis of the Use of ETDNO in the Treatment of PIPJ Flexion Contracture:
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