Management of Proximal Interphalangeal (PIP) Joint Injuries

Official title

An Innovative Approach to the Management of Proximal Interphalangeal (PIP) Joint Injuries

Overview

This project seeks to compare the treatment efficacy of two different approaches to treating interphalangeal joint (PIP) joint injuries. The investigators will compare two participant groups undergoing treatment using the current treatment standard (Coban wrap) as well as an innovative treatment approach (neoprene sleeve) in treating the PIP joint injury.

Detailed description

Hand injuries, specifically those involving the proximal interphalangeal joint (PIP) can be difficult to treat. These stubborn injuries leave patients with pain, edema, and limitation in function and changes in the aesthetics of the hand. This project would randomize patients with PIP joint injuries including dislocation, volar plate, intra-articular fracture and chip avulsion fracture with ligamentous injury into two groups. The first group will receive the usual treatment including active range motion, edema control - contrast bath and coban. The second group would receive similar treatment except a custom neoprene sleeve will be used in place coban. Outcome measures would include: Numeric Pain Rating Scale (NPRS), measure of patient satisfaction and compliance with the coban vs a custom neoprene sleeve and a measure of hand function (Patient Rated Wrist/Hand Evaluation) as well as a range of motion and edema.

Interventions

• Other Coban wrap
  A Coban bandage or wrap is a self-adhering elastic wrap that sticks to itself but not to skin or clothing. It is commonly used as a wrap on limbs due to its ability to adhere to itself and not loosen. Coban is often used as a compression bandage
• Other Neoprene sleeve
  Neoprene sleeve is an innovative treatment approach, it consists of a synthetic rubber-like material used to provide compressive support. Neoprene sleeves can provide protection, light compression and mild extension support while allowing full finger flexion.

Primary outcome measures

• Changes in Edema [Time frame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]
• Changes in Pain [Time frame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]

Secondary outcome measures (2)

• Range of Motion [Time frame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]
• Function and Appearance [Time frame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.]

Eligibility criteria

Inclusion criteria

• Read/write and speak/understand English
• Capable of understanding the various questionnaires that will be employed to collect outcome measures

Exclusion criteria

• Participants who do not meet all of the aforementioned criteria
• Participants with any injuries specific to the treatment finger, or if there is any underlying disease affecting the PIP joint

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Unity Health Toronto — Toronto

Identifiers

NCT: NCT06951607 · 23-240

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗