The purposes of this study were to compare the efficacy of a new dorsal wrist splinting versus routine palmar splinting for CTS (both in neutral position). In this single blind randomized controlled trial, 24 CTS cases were recruited from the patients with clinical diagnosis of carpal tunnel syndrome for at least one month prior to the study and median neuropathy was confirmed by electro diagnostic test. The patients who had previously received surgical or nonsurgical treatments were excluded. The patients were randomly assigned to use dorsal or palmar splint for 4 weeks. Sensory and motor conductions of the median nerve were measured at the baseline and after 1 month and the results were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903224157N1
Registration date:2009-03-05, 1387/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-03-05, 1387/12/15
Registrant information
Name
Azam Bagheri
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2021
Email address
a.bagheri@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellery for research, Isfahan University Of Medical Sciences
Expected recruitment start date
2009-03-05, 1387/12/15
Expected recruitment end date
2009-10-22, 1388/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dorsal wrist splint versus cock-up for carpal tunnel syndrome on median nerve conduction measurements
Public title
Effect of splinting for carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of CTS diagnosed clinically for at least one month prior to the study and electrophysiological evidence of median neuropathy
Exclusion criteria: pregnancy, previously treated by surgery, steroid injection, or any other treatments, presence of neck arthroses
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University Of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
empty
Ethics committee reference number
288103
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
carpal tunnel syndrome
Primary outcomes
1
Description
median sensory peak latency
Timepoint
before intrevention and four weeks after intervention
Method of measurement
by medtronic electromyography, anti dromic, in millisecound
2
Description
median sensory amplitude
Timepoint
before intrevention and four weeks after intervention
Method of measurement
by medtronic electromyography, anti dromic, in millimeter
3
Description
median sensory nerve conduction velocity
Timepoint
before intrevention and four weeks after intervention
Method of measurement
by medtronic electromyography, anti dromic, in m/s
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:dorsal splint in neutral angle of wrist, 4 weeks, nights and days except for rest
Category
Rehabilitation
2
Description
control group: conventional palmar wrist splint in neutral angle, 4 weeks, nights and days except for rest
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Amin Hospital
Full name of responsible person
A'zam Bagheri
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences, Vice Chancellery For Reasearch
Full name of responsible person
Dr. Peiman Adibi
Street address
Vice Chancellery For Reasearch, Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University Of Medical Sciences, Vice Chancellery For Reasearch
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
Isfahan University Of Medical Sciences
Full name of responsible person
A'zam Bagheri
Position
MSc Technical Orthopedic
Other areas of specialty/work
Street address
School of Rehabilitation, Isfahan University Of Medical Sciences,
City
Isfahan
Postal code
Phone
+98 913 217 5466
Fax
Email
a_bagheriy@yahoo.coma.bagheri@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
A'zam Bagheri
Position
MSc, Technical Orthopedic
Other areas of specialty/work
Street address
Department of Technical Orthopedic, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 913 217 5466
Fax
Email
a_bagheriy@yahoo.coma.bagheri@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
A'zam Bagheri
Position
MSc,Technical Orthopedic
Other areas of specialty/work
Street address
Department of Technical Orthopedic, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran.
City
Isfahan
Postal code
8415964813
Phone
+98 31 1792 2021
Fax
Email
A.bagheri@uswr.ac.ira_bagheriy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)