Comparing the functional results, pain, range of motion and angulation of buddy taping versus closed reduction and splint immobilization in patients with fifth metacarpal neck fractures; A prospective trial
Comparison of two treatments of buddy taping versus closed reduction and splinting of metacarpal neck fractures in regard of pain, function, range of motion and angulation.
Design
Clinical trial with parallel groups on 60 patients
Settings and conduct
This study is a clinical trial without blinding, will be performed on the all patients who have the metacarpal neck fracture. Blinding is not possible due to the nature of the study and both the interventionist and the patients see the method of treatment . In this study, patients referred to the emergency department of Imam Khomeini and Golestan hospitals in Ahvaz will be examined. All patients who have the fracture are selected and divided into two groups and are treated by closed reduction and splinting or buddy taping.
Participants/Inclusion and exclusion criteria
Inclusion criteria are metacarpal 5 neck fracture during the last 72 hours .
Exclusion criteria include comminuted neck fracture, angulation more than 70 degrees, rotational deformity, previous fracture, open fracture, concomitant upper limb fracture, concomitant tendon injury, multiple trauma, and patients who are unable to complete follow-up.
Intervention groups
Patients were divided into closed reduction and splinting (Ulnar Gutter) group and buddy taping group.
Main outcome variables
Pain; Range of motion; Hand grip strength; Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211225053518N1
Registration date:2022-01-11, 1400/10/21
Registration timing:registered_while_recruiting
Last update:2022-01-11, 1400/10/21
Update count:0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
Sadegh Ehsanbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 4155
Email address
ehsanbakhsh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-09, 1400/10/19
Expected recruitment end date
2022-03-10, 1400/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the functional results, pain, range of motion and angulation of buddy taping versus closed reduction and splint immobilization in patients with fifth metacarpal neck fractures; A prospective trial
Public title
buddy taping in Boxer fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
neck of 5th metacarpal fracture
acute fracture (72 hour)
Exclusion criteria:
Comminuted fracture
Patients who can not complete follow-up.
More of 70 degree of angulation
Rotational deformity
Previous fracture
Open fracture
Upper limb fracture on the same side
Tendon injury
Multiple truama
Age
From 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences
Street address
University City, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, ground floor.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-10-12, 1400/07/20
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.143
Health conditions studied
1
Description of health condition studied
Neck of 5th metacarpal fracture; Boxer fracture
ICD-10 code
S62.2
ICD-10 code description
Fracture of first metacarpal bone
Primary outcomes
1
Description
Pain
Timepoint
Initial visit and 3 weeks later
Method of measurement
Visual Analogue Scale
2
Description
Range of motion
Timepoint
Initial visit and 3 weeks later
Method of measurement
examination
3
Description
Dysfunction
Timepoint
3 weeks later
Method of measurement
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:buddy taping finger 5 and 4 (put together) during 3 weeks
Category
Treatment - Devices
2
Description
Control group: Closed reduction and splinting by ulnar gutter (fiberglass 3inch) during 3 weeks
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Sadegh Ehsanbakhsk
Street address
Ahvaz - Golestan Alley - Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3333 3477
Email
Golestanjpsital@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Sadegh Ehsanbakhsk
Street address
Azadegan St. (24 meters) Imam Khomeini Educational and Medical Center
City
Ahvaz
Province
Khouzestan
Postal code
65794-61357
Phone
+98 61 2222 2818
Email
eduaum@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zaker Kish
Street address
University City, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Ground Floor
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3333 3477
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sadegh Ehsanbakhsh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6456134641
Phone
+98 61 3311 4155
Fax
Email
ehsanbakhsh.s@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sadegh Ehsanbakhsh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6456134641
Phone
+98 61 3373 8383
Email
ehsanbakhsh.s@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sadegh Ehsanbakhsh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6456134641
Phone
+98 61 3373 8383
Email
ehsanbakhsh.s@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available