High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness

Sponsor

Vicenç Punsola Izard (Other)

Overall Status

Completed

CT.gov ID

NCT05625451

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.

Condition or Disease	Intervention/Treatment	Phase
Proximal Interphalangeal Finger Joint Contractures	Device: Elastic Tension Digital Neoprene Orthosis	N/A

Detailed Description

Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?

Design: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat

Participants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture

Intervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.

Outcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treatRandomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Comparison Between Two Intervals of Daily Total End Range Time for Treatment of Proximal Interphalangeal Joint Flexion Contracture Using an Elastic Tension Digital Neoprene Orthosis

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20-22 hours of daily total end range time intervention used the elastic tension digital neoprene orthosis from twenty to twenty-two hours	Device: Elastic Tension Digital Neoprene Orthosis The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups.
Active Comparator: 11-13 hours daily total end range time intervention used the elastic tension digital neoprene orthosis from eleven to thirteen hours	Device: Elastic Tension Digital Neoprene Orthosis The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups.

Arm

Intervention/Treatment

Experimental: 20-22 hours of daily total end range time intervention

used the elastic tension digital neoprene orthosis from twenty to twenty-two hours

Device: Elastic Tension Digital Neoprene Orthosis

The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups.

Active Comparator: 11-13 hours daily total end range time intervention

used the elastic tension digital neoprene orthosis from eleven to thirteen hours

Device: Elastic Tension Digital Neoprene Orthosis

Outcome Measures

Primary Outcome Measures

Change in the proximal interphalangeal joint extension [7 days]
difference in passive finger extension between the first day and the seventh day
Change in the proximal interphalangeal joint extension [21 days]
difference in passive finger extension between the first day and the twenty first day
- Modified Weeks Test [fifteen minutes]
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
- Contraction Test [21 days]
Finger reaction at release of the orthosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patient Inclusion Criteria:

Patients with flexion contractures of the proximal interphalangeal joint after trauma or post-surgical complications.
Patients with long standing flexion contractures
Patients with contractures greater than 45º.

Exclusion Criteria:

Patients with acute tendon injuries or fractures
Patients with inflammatory conditions,
Patients with proximal interphalangeal joint replacements,
Patients with Dupuytren conservative treatments
Patients lacking active proximal interphalangeal joint extension

Contacts and Locations

Locations

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

Sponsors and Collaborators

Vicenç Punsola Izard

Investigators

None specified.

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:

NCT05625451

Other Study ID Numbers:

First Posted:

Nov 23, 2022

Last Update Posted:

Nov 30, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Additional relevant MeSH terms:

Contracture

Study Results

No Results Posted as of Nov 30, 2022