Clinical trial NCT05625451: High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Interphalangeal Finger Joint Contractures
Lead sponsor: Hand Therapy Barcelona
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Change in the proximal interphalangeal joint extension
timeFrame: 7 days
measure: Change in the proximal interphalangeal joint extension
timeFrame: 21 days
measure: - Modified Weeks Test
timeFrame: fifteen minutes
measure: - Contraction Test
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hand Therapy Barcelona
Study officials:
References: