Clinical trial NCT06951607: Management of Proximal Interphalangeal (PIP) Joint Injuries
Official title: An Innovative Approach to the Management of Proximal Interphalangeal (PIP) Joint Injuries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interphalangeal Joint Injury
Keywords: PIP Injury
Coban wrap
Neoprene Sleeve
Interphalangeal Joint
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Edema
timeFrame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.
measure: Changes in Pain
timeFrame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.
Secondary outcomes:
measure: Range of Motion
timeFrame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.
measure: Function and Appearance
timeFrame: The outcome measures will be collected at various intervals, such as initial visit, 2 weeks, 4 weeks, 3 months and 6 months.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto
Study officials:
affiliation: Unity Health Toronto
name: Susan Ellis
role: PRINCIPAL_INVESTIGATOR
References: