Evaluation of the effectiveness of oral Aspirin in reducing complex regional pain syndrome (CRPS) in distal radius fractures treated with closed reduction and percutaneous pinning
Evaluation of the effectiveness of oral aspirin in reducing complex regional pain syndrome (CRPS) in distal radius fractures treated with closed reduction and percutaneous pinning
Design
control group was the same as the intervention group. study was double-blinded and randomized. sample size for each group was 40 patients.
Settings and conduct
Location: from August 2016 to September 2017, in the department of Orthopedics Surgery, Hazrat-e Rasool Hospital
Study protocol: The protocol was initiated in the emergency department after signature of the informed consent form. The patients were randomly allocated a box containing aspirin or placebo (randomization was performed according to a table of random numbers by the pharmacist), beginning from the emergency department. All boxes and capsules had been made by a pharmacist in the same appearance and taste.
Patients were assessed clinically and radiographically at two weeks, four weeks (the cast was shorted), six weeks (pins and cast were removed) and twelve weeks by a physician who was unaware of the treatment allocation. CRPS was clinically assessed with the use of the “Budapest criteria”,
Participants/Inclusion and exclusion criteria
patients 18 years old or over with isolated, extra-articular and low energy distal radius fractures which should be treated with percutaneous pinning
Intervention groups
intervention: perscription of oral aspirin or placebo to intervention group and control group for evaluation of the effectiveness of oral aspirin in reducing complex regional pain syndrome (CRPS) in distal radius fractures
intervention group: patients with the mentioned inclusion criteria who receive oral aspirin
control group: patients with the mentioned inclusion criteria who receive placebo
Main outcome variables
Complex Regional Pain Syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180116038391N1
Registration date:2018-03-03, 1396/12/12
Registration timing:retrospective
Last update:2018-03-03, 1396/12/12
Update count:0
Registration date
2018-03-03, 1396/12/12
Registrant information
Name
Nima Hosseinzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2264
Email address
hosseinzade.nima@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-10-22, 1396/07/30
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of oral Aspirin in reducing complex regional pain syndrome (CRPS) in distal radius fractures treated with closed reduction and percutaneous pinning
Public title
Evaluation of the effectiveness of oral Aspirin in reducing complex regional pain syndrome (CRPS)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
closed, unilateral, extra-articular distal radius fracture
eighteen years and over
Exclusion criteria:
history of taking medications that were involved in the treatment of CRPS (such as antidepressants, anticonvulsants, corticosteroids and vitamin C)
previous wrist or hand fracture on the same side
neurovascular injury
fractures with high energy mechanism or multiple trauma-injured patients, multiple fractures at different places
contraindication to take aspirin and acetaminophen
open fractures
articular displacement requiring open reduction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Actual sample size reached:
91
Randomization (investigator's opinion)
Randomized
Randomization description
individual randomization with closed envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients were randomly allocated a box containing aspirin or placebo (randomization was performed according to a table of random numbers by the pharmacist). All boxes and capsules had been made by a pharmacist in the same appearance and taste. The study was double-blind. All participants, nurses, physiotherapists, physicians and researchers were unaware of the treatment allocation and the pharmacist was the only individual with the access to the code until the end of the analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Iran University of Medical Sciences
Street address
Hazrat-e Rasool Hospital, Niyayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9311242007
Health conditions studied
1
Description of health condition studied
Complex regional pain syndrome
ICD-10 code
G90.5
ICD-10 code description
Complex regional pain syndrome I (CRPS I)
2
Description of health condition studied
distal radius fracture
ICD-10 code
S62
ICD-10 code description
Fracture at wrist and hand level
Primary outcomes
1
Description
Complex regional pain syndrome
Timepoint
2, 4, 6 and 12 week post operation
Method of measurement
Budapest’s criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aspirin 500mg po daily for 7days
Category
Prevention
2
Description
Control group: placebo capsule daily for 7 daye
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e Rasool Hospital
Full name of responsible person
Nima Hosseinzadeh
Street address
Hazrat-e Rasool Hospital, Niyayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 6435 2265
Email
hosseinzade.nima@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nima Hosseinzadeh
Street address
Rasool Akram Hospital, Niayesh street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2264
Email
nima_hd87@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Nima Hosseinzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Rasool Akram Hospital, Niayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 6435 2264
Fax
+98 21 6650 7059
Email
hosseinzade.nima@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nima Hosseinzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Rasool Akram Hospital, Niayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 6435 2264
Fax
+98 21 6650 7059
Email
hosseinzade.nima@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nima Hosseinzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Rasool Akram Hospital, Niayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 6435 2264
Fax
+98 21 6650 7059
Email
hosseinzade.nima@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about fractures,medical treatment and the incidence of CRPS
When the data will become available and for how long
After publishing the results in journals
To whom data/document is available
Physicians, physiotherapists
Under which criteria data/document could be used
Only for scientific purposes
From where data/document is obtainable
Email
What processes are involved for a request to access data/document