Proximal Interphalangeal Joint Stiffness
Conditions
Brief summary
The purpose of this feasibility pilot study is to determine the effectiveness of Relative Motion Orthosis (RMO) in regaining finger range of motion compared to standard care in patients diagnosed with Proximal Interphalangeal (PIP) stiffness with an extension lag secondary to finger injury. Participants will be enrolled and randomized into groups receiving either standard conservative interventions or standard interventions in addition to the RMO. The primary endpoint is to evaluate the efficacy of relative motion orthosis in PIP ROM using clinical scoring and physical exam findings.
Interventions
DEVICERMO flexion orthosis (splint)
RMO flexion is an orthosis fabricated by hand therapists made of thermoplastic material design to position the involved finger in relative flexion at the metacarpal joint compared to adjacent fingers to facilitate PIP extension during daily activity use.
OTHERStandard of care
Treatment includes finger stretches, active range of motion (AROM), passive range of motion (PROM), thermal modalities, LMB finger extension orthosis.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age range 18-80 * Any gender * Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension * Right or left hand injury * Level of Chronicity (4 weeks - 6 months) * Able to follow instructions
Exclusion criteria
* PIP with hard end feel (feels they need serial casting) - level of chronicity * Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis * Severe arthropathy * Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score | Baseline, End-of-treatment (~Month 3) | The QuickDASH Questionnaire consists of 30 items where each question in the scale is scored between 1 and 5. The total score ranges from from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms). A decrease from baseline indicates improvement in symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Active Range of Motion (AROM) | Baseline, End-of-treatment (~Month 3) | Active Range of Motion (AROM) measurement will be evaluated using a universal goniometer. The goniometer is placed at the joint, and the joint is moved through its range of motion. The goniometer measures the angle in degrees, ranging from 0 to 180. An increase from baseline indicates improved range of motion. |
Countries
United States
Contacts
CONTACTNatalia Ruiz, DPT
PRINCIPAL_INVESTIGATORNatalia Ruiz, DPT
NYU Langone Health
Outcome results
None listed