NCT05625451

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Vicenç Punsola Izard · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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

Conditions

• Proximal Interphalangeal Finger Joint Contractures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-06-01
• Completion: 2022-01-01
• First posted: 2022-11-23
• Last updated: 2022-11-30

Locations

1 site across 1 country: Spain