Efficacy of corticosteroids injection in prevention of reflex sympathetic dystrophy and ulnar sided wrist pain in patients with acute extra articular distal radius fractures
The aim of the present study is to determine the efficacy of corticosteroids to decrease or prevent the occurrence of ulnar sided wrist pain and/or complex regional pain syndrome in patients with distal radius fractures. The inclusion criteria will be as follows: 1. informed consent for entrance 2. adult (>18 y/o) with distal 1 inch radius fracture 3. intact or non displaced fractured ulnar styloid and 4. at least 6 months of follow up. The exclusion criteria will be as follows: 1. Pathological fractures 2. Severe osteoporosis 3. Any open surgical intervention. Patients referred to Dr Bahonar Hospital, meeting the entrance criteria will be divided into 4 random groups: 1. intact ulnar styloid, corticosteroid, 2. intact ulnar styloid, placebo, 3. fractured ulnar styloid, corticosteroid, and 4.fractured ulnar styloid, placebo. In the corticosteroid group, after anesthesia the patient will receive a corticosteroid injection (2 ampules of betamethazone L.A.) in the area of ulnar styloid and another one (2 ampules of dexamethazone) in the flexor tendons of the fingers proximal to wrist flexion crease, while in the placebo group only distilled water and lidocaine will be injected. Finger motion will be encouraged in all of the patients. The cast will be shortened 2 weeks later and removed after 6 weeks. Patients will be followed at 3 months intervals after the fracture fro one year. All of the range of motions of the wrist and fingers will be recorded in every follow up and the patient will be asked about pain in the ulnar side of the wrist and will be observed for any signs and symptoms of reflex sympathetic dystrophy. In the 3 and 6 months and at the 1 year follow ups DASH score will be measured and recorded too. Finally the data will be analyzed by SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104062115N1
Registration date:2011-04-22, 1390/02/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-04-22, 1390/02/02
Registrant information
Name
Ali Reza Saied
Name of organization / entity
Kerman Neurosceince research center, Kerman University of medical sciecnes
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 6432
Email address
arsaied@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kerman University of medical sciecnes, Kerman neuroscience center
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2012-05-01, 1391/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of corticosteroids injection in prevention of reflex sympathetic dystrophy and ulnar sided wrist pain in patients with acute extra articular distal radius fractures
Public title
Efficacy of corticosteroids injection in prevention of reflex sympathetic dystrophy and ulnar sided wrist pain in patients with acute extra articular distal radius fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent for entrance; adult (>18 y/o) with distal 1 inch radius fracture; intact or non displaced fractured ulnar styloid and at least 6 months of follow up. The exclusion criteria : pathological fractures; Severe osteoporosis; any open surgical intervention.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences ethics committee
Street address
Thamasbabad cross road, Vice chancellor for research, Kerman University of Medical Sciences, Kerman, Iran
City
Kerman
Postal code
Approval date
2011-03-16, 1389/12/25
Ethics committee reference number
EC/KNRC/89-93
Health conditions studied
1
Description of health condition studied
Distal radius fractures
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
pain in the ulnar side of wrsit
Timepoint
3 months
Method of measurement
visual analogue score (the patient gives a number, 1 to 10, to the experienced pain)
Secondary outcomes
1
Description
Wrsit and forearm rotation compared to the opposite side
Timepoint
every 3 months
Method of measurement
observation and measurement
Intervention groups
1
Description
Injection of 2 vials of betametahsone LA in the triangular fibrocartilage complex and 16 mg of dexamethasone in the flexor digitorum sheet in intervention groups, regardless of ulnar styloid fracture
Category
Prevention
2
Description
Injection of lidoacaine and distilled water in the triangular fibrocartilage omplex and flexor digirorum sheet in the control groups
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Dr Bahonar Hospital
Full name of responsible person
Dr Ali Reza Saied
Street address
Gharani Street, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Dr Vahid Sheibani
Street address
Thamasbabad crossroad, Vice chancellor for research, Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Ali Reza Saied
Position
Associate professor of orthopedics
Other areas of specialty/work
Street address
Dr Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1247 6431
Fax
Email
arsaiedmd@yahoo.com;
Web page address
arsaiedmd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of medical sciences
Full name of responsible person
Dr Ali Reza Saied
Position
Hand surgery fellowship
Other areas of specialty/work
Street address
Dr Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1247 6431
Fax
Email
arsaiedmd@yahoo.com; arsaiedmd@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of medical sciecnes
Full name of responsible person
Dr Ali Reza Saied
Position
Associate Professor of orthopedics
Other areas of specialty/work
Street address
Dr Bahonar Hospital
City
Kerman
Postal code
7688767543
Phone
+98 34 1247 6431
Fax
+98 34 1223 1960
Email
arsaiedmd@yahoo.com; arsaiedmd@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)