Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture

October 21, 2016 updated by: Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Splint
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.
Behavioral: Splint
fibreglass splint
Experimental: Behavioral Modification
Patients are given a removable plaster/fiberglass splint with a tensor bandage underneath
Behavioral: Behavioral Modification
Patient will be provided with tensor bandage and instructed on specific behaviors to prevent movement of the injured part of the hand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand function
Time Frame: 4 weeks
measured by Brief Michigan Hand Questionnaire (MHQ)
4 weeks
hand function
Time Frame: 8 weeks
measured by Brief Michigan Hand Questionnaire (MHQ)
8 weeks
hand function
Time Frame: 12 weeks
measured by Brief Michigan Hand Questionnaire (MHQ)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grip strength
Time Frame: 4 weeks
measured using Dynamometer
4 weeks
Grip strength
Time Frame: 8 weeks
measured using Dynamometer
8 weeks
Grip strength
Time Frame: 12 weeks
measured using Dynamometer
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 341-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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