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

Vicenç Punsola Izard

Status: Completed

Conditions: Proximal Interphalangeal Finger Joint Contractures

Treatments: Device: Elastic Tension Digital Neoprene Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05625451

002

Details and patient eligibility

About

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.

Full 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

Enrollment: 91 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 2 patient groups

20-22 hours of daily total end range time intervention

Experimental group

Description:

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

Treatment:

Device: Elastic Tension Digital Neoprene Orthosis

11-13 hours daily total end range time intervention

Active Comparator group

Description:

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

Treatment:

Device: Elastic Tension Digital Neoprene Orthosis