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Management of Proximal Interphalangeal (PIP) Joint Injuries

NCT ID: NCT06951607

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Interphalangeal Joint Injury

Keywords

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PIP Injury Coban wrap Neoprene Sleeve Interphalangeal Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will take place at St. Joseph's Health Centre, Unity Health Toronto, in Toronto, Canada. The St. Joseph's site is capable of recruiting the required number of patients (40 total) for both the control (Group 1 - coban treatment) and the innovative treatment group (Group 2 - custom neoprene sleeve). The study design will be a randomized control trial, where participants will be randomly assigned to one of the two treatment groups, with 20 participants assigned to each treatment modality. Patients will be observed over a 6-month period, and outcome measures will be collected at initial assessment, 2 weeks, 4 weeks, 3 months and 6 months. Prior to study enrollment, written informed consent will be obtained from all participants.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Coban wrap

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Neoprene sleeve

Intervention Type OTHER

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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Ellis

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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Unity Health Toronto

Toronto, , Canada

Site Status

Countries

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Canada

Central Contacts

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Daniela Bellicoso

Role: CONTACT

Phone: 4169021877

Email: [email protected]

Keum Yung Choi

Role: CONTACT

Email: [email protected]

Facility Contacts

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Daniela Bellicoso

Role: primary

Keum Yung Choi

Role: backup

Other Identifiers

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23-240

Identifier Type: -

Identifier Source: org_study_id