Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05625451
Enrollment
91
Registered
2022-11-23
Start date
2020-11-01
Completion date
2022-01-01
Last updated
2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Interphalangeal Finger Joint Contractures

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

Interventions

DEVICEElastic 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.

Sponsors

Vicenç Punsola Izard
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the proximal interphalangeal joint extension7 daysdifference in passive finger extension between the first day and the seventh day
- Modified Weeks Testfifteen minutesDifference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
- Contraction Test21 daysFinger reaction at release of the orthosis

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026