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

NCT ID: NCT05625451

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-01-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

20-22 hours of daily total end range time intervention

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

Group Type: EXPERIMENTAL

Elastic Tension Digital Neoprene Orthosis

Intervention Type: 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.

11-13 hours daily total end range time intervention

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

Group Type: ACTIVE_COMPARATOR

Elastic Tension Digital Neoprene Orthosis

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vicenç Punsola Izard

OTHER

Sponsor Role: lead

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

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hand Therapy Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id