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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coban wrap | Active Comparator | 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. |
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| Neoprene Sleeve | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coban wrap | 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 |
| 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. |
| 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. |
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Inclusion criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Bellicoso | Contact | 4169021877 | Daniela.Bellicoso@unityhealth.to | |
| Keum Yung Choi | Contact | KeumYung.Choi@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Susan Ellis | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unity Health Toronto | Toronto | M5B 1W8 | Canada |
The research will be published and disseminated within the organization and/or in a scientific journal.
After the data has been collected and analyzed.
Only the study personnel have access to the study information.
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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.
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| Neoprene sleeve | 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. |
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| 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. |