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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 91
- Locations
- 2
- Primary Endpoint
- Change in the proximal interphalangeal joint extension
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change in the proximal interphalangeal joint extension
Time Frame: 21 days
difference in passive finger extension between the first day and the twenty first day
- Contraction Test
Time Frame: 21 days
Finger reaction at release of the orthosis
- Modified Weeks Test
Time Frame: fifteen minutes
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
Secondary Outcomes
No secondary outcomes reported
Investigators
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
Hand Therapy Barcelona
