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

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT02547181
Collaborator
(none)
40
1
2
40
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Modification
  • Behavioral: Splint
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparing Short-term Function and Pain After No Treatment or Splinting for Boxer's Fracture
Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. hand function [4 weeks]

    measured by Brief Michigan Hand Questionnaire (MHQ)

  2. hand function [8 weeks]

    measured by Brief Michigan Hand Questionnaire (MHQ)

  3. hand function [12 weeks]

    measured by Brief Michigan Hand Questionnaire (MHQ)

Secondary Outcome Measures

  1. Grip strength [4 weeks]

    measured using Dynamometer

  2. Grip strength [8 weeks]

    measured using Dynamometer

  3. Grip strength [12 weeks]

    measured using Dynamometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02547181
Other Study ID Numbers:
  • 341-2014
First Posted:
Sep 11, 2015
Last Update Posted:
Oct 24, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2016