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Management of Proximal Interphalangeal (PIP) Joint Injuries

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06951607
Enrollment
40
Registered
2025-04-30
Start date
2025-06-01
Completion date
2026-03-31
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interphalangeal Joint Injury

Keywords

PIP Injury, Coban wrap, Neoprene Sleeve, Interphalangeal Joint

Brief summary

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

OTHERCoban 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

OTHERNeoprene 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.

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in EdemaThe outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.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.
Changes in PainThe outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.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).

Secondary

MeasureTime frameDescription
Range of MotionThe outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.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).
Function and AppearanceThe outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.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.

Countries

Canada

Contacts

Primary ContactDaniela Bellicoso
Daniela.Bellicoso@unityhealth.to4169021877
Backup ContactKeum Yung Choi
KeumYung.Choi@unityhealth.to

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026