Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture
Primary Purpose
Metacarpal Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Behavioral Modification
Splint
Sponsored by
About this trial
This is an interventional treatment trial for Metacarpal Fractures focused on measuring Fracture, Follow-up, metacarpal
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of true boxer's fracture
- Candidate for either supportive splinting or tensor bandage
- Speaking, read and write English
Exclusion Criteria:
- Prior surgical treatment for boxer's fractures or other hand conditions.
- Concurrent hand/wrist injury
Sites / Locations
- Sunnybrook Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Splint
Behavioral Modification
Arm Description
Patients will be provided instructed to use a tensor bandage as well as specific behaviours to prevent movement of the injured part of the hand.
Patients are given a removable plaster/fiberglass splint with a tensor bandage underneath
Outcomes
Primary Outcome Measures
hand function
measured by Brief Michigan Hand Questionnaire (MHQ)
hand function
measured by Brief Michigan Hand Questionnaire (MHQ)
hand function
measured by Brief Michigan Hand Questionnaire (MHQ)
Secondary Outcome Measures
Grip strength
measured using Dynamometer
Grip strength
measured using Dynamometer
Grip strength
measured using Dynamometer
Full Information
NCT ID
NCT02547181
First Posted
March 6, 2015
Last Updated
October 21, 2016
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT02547181
Brief Title
Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture
Official Title
Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Study is being done because the investigators would like to know if pain and hand function after having a boxer's fracture differs between being treated with supportive splinting or without splinting, but with behavioral modifications.
Detailed Description
After initial treatment in the emergency department, patients with boxer's features are referred to the division of plastic and reconstructive surgery at Sunnybrook hospital. During initial consultation with the hand surgeon, treatment is chosen. Patients are follow-up with their hand surgeon at 4-, 8-, and 12--week intervals.
Supportive splinting: Patient's are given a removable plaster/fiberglass splint with a tensor bandage underneath.
Behavioral Modifications: Patients are not splinted, but provided a tensor bandage. Patients are instructed on specific behaviours to prevent movement of the injured part of the hand.
The purpose of the study is to compare pain and short-term hand function in patients who undergo supportive splinting compared to patients who undergo behavioral modifications treatment only to see which option is associated with shorter functional recovery and which option is associated with less pain during the first 4 weeks after initial treatment.
On follow-up appointments at 4, 8,and 12 weeks, as well as initial consultation with the hand surgeon, participants will be asked to perform a grip strength test with a Jamal Hydraulic hand Dynanometer. Participants will be asked to fill out a Brief Michigan Hand Questionnaire along with the grip strength test as well as quick demographics survey at initial consultation with the hand surgeon. After the 12-week follow up appointment, study participation will end.
If a patient is unable to follow-up with the hand surgeon, the Brief Michigan Hand Questionnaire will be done via phone whenever is most convenient for the patient. It's anticipated that about 40 people will participate in this study at a single centre in Toronto.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metacarpal Fractures
Keywords
Fracture, Follow-up, metacarpal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Splint
Arm Type
Experimental
Arm Description
Patients will be provided instructed to use a tensor bandage as well as specific behaviours to prevent movement of the injured part of the hand.
Arm Title
Behavioral Modification
Arm Type
Experimental
Arm Description
Patients are given a removable plaster/fiberglass splint with a tensor bandage underneath
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Modification
Intervention Description
Patient will be provided with tensor bandage and instructed on specific behaviors to prevent movement of the injured part of the hand.
Intervention Type
Behavioral
Intervention Name(s)
Splint
Intervention Description
fibreglass splint
Primary Outcome Measure Information:
Title
hand function
Description
measured by Brief Michigan Hand Questionnaire (MHQ)
Time Frame
4 weeks
Title
hand function
Description
measured by Brief Michigan Hand Questionnaire (MHQ)
Time Frame
8 weeks
Title
hand function
Description
measured by Brief Michigan Hand Questionnaire (MHQ)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Grip strength
Description
measured using Dynamometer
Time Frame
4 weeks
Title
Grip strength
Description
measured using Dynamometer
Time Frame
8 weeks
Title
Grip strength
Description
measured using Dynamometer
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of true boxer's fracture
Candidate for either supportive splinting or tensor bandage
Speaking, read and write English
Exclusion Criteria:
Prior surgical treatment for boxer's fractures or other hand conditions.
Concurrent hand/wrist injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine McMillan, MSc
Email
Catherine.mcmillan@sunnybrook.ca
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine McMillan, MSc
Email
catherine.mcmillan@sunnybrook.ca
12. IPD Sharing Statement
Learn more about this trial
Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture
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