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OpenTrials
Completed

NCT Number: NCT05625451

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hand Therapy Barcelona

Barcelona, 08010, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elastic Tension Digital Neoprene Orthosis

Device

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.

Primary outcomes

  1. Change in the proximal interphalangeal joint extension

    Time frame: 7 days

    difference in passive finger extension between the first day and the seventh day

  2. Change in the proximal interphalangeal joint extension

    Time frame: 21 days

    difference in passive finger extension between the first day and the twenty first day

  3. - Modified Weeks Test

    Time frame: 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

  4. - Contraction Test

    Time frame: 21 days

    Finger reaction at release of the orthosis

Sponsors and collaborators

Lead sponsor

Vicenç Punsola Izard

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 23, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.