Management of Proximal Interphalangeal (PIP) Joint Injuries

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Interphalangeal Joint Injury
• Intervention / Treatment: Other: Coban wrap; Other: Neoprene sleeve

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Bellicoso; Phone Number: 4169021877; Email: Daniela.Bellicoso@unityhealth.to
• Study Contact Backup: Name: Keum Yung Choi; Email: KeumYung.Choi@unityhealth.to

Study Locations

• Canada
  • Toronto, Canada, M5B 1W8
    • Unity Health Toronto
    • Contact: Daniela Bellicoso; Phone Number: 4169021877; Email: Daniela.Bellicoso@unityhealth.to
    • Contact: Keum Yung Choi; Email: KeumYung.Choi@unityhealth.to
    • Contact: Susan Ellis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coban wrap; The Coban wrap is a compressive adhesive bandage used to joint injuries. Participants in this arm will receive a Coban wrap as a form of treatment with outcome measures occurring at the initial visit, 2 weeks, 4 weeks, 3 months and 6 months.	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
Experimental: Neoprene Sleeve; Neoprene sleeve is an innovative treatment approach, it consists of a synthetic rubber-like material used to provide compressive support. Participants in this arm will receive a sleeve as a form of treatment with outcome measures occurring at the initial visit, 2 weeks, 4 weeks, 3 months and 6 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Edema	The aim of the current study is to compare the treatment efficacy of a custom neoprene sleeve vs. a coban wrap in treating PIP joint injuries. In order to measure to measure treatment changes in edema (swelling) for PIP joint injuries. Edema will be measured using an instrument consisting of ring gage to determine whether the patient has experienced a decrease in swelling based on the circumferential numerical measurement comparison from their previous visit.	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	The aim of the current study is to compare the treatment efficacy of a custom neoprene sleeve vs. a coban wrap in treating PIP joint injuries. The second primary outcome measure of interest is the level of pain that a patient may be experiencing at various intervals post injury, which can be measured using the Numeric Pain Rating Scale (NPRS).	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

Outcome Measure	Measure Description	Time Frame
Range of Motion	To measure range of motion during patient visit intervals, clinicians will be using an instrument known as a goniometer to determine the extent of which the patient has regained their range of motion post injury between the two treatment conditions (Coban wrap vs. neoprene sleeve).	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	To measure function and appearance, clinicians will be administering the Patient Rated Wrist/Hand Evaluation (PRWHE) to determine the extent to which patients report regaining the function of their finger joints post injury, the scale includes a section which addresses patients' perceptions around appearance.	The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Susan Ellis, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: PIP Injury; Coban wrap; Neoprene Sleeve; Interphalangeal Joint
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 23-240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research will be published and disseminated within the organization and/or in a scientific journal.
• IPD Sharing Time Frame: After the data has been collected and analyzed.
• IPD Sharing Access Criteria: Only the study personnel have access to the study information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No