Evaluation the effect of corticosteroid injection with and without sonography guide in electro-diagnostic and clinical findings of patients with carpal tunnel syndrome
The aim of this study is to compare the effect of corticosteroid injection with and without ultrasound guide in treatment of patients with carpal tunnel syndrome.
The patients who have paraesthesia or numbness in hand and confirm as moderate or severe carpal tunnel syndrome according to electro diagnostic findings, will enter the study.
Patients with wrist surgery or tennar atrophy will be excluded.
This study will be done in patients refer to physical medicine and rehabilitation clinic of AL Zahra and Ayatollah kashani hospitals of Isfahan during 1395 and suffering from carpal tunnel syndrom.
30 patients in each group will enrol the study and will divide randomly in two groups.
In case group 40 mg methyl prednisolone will be injected at wrist according ulnar in-plane approach.
In control group 40 mg methyl prednisolone will be injected at distal wrist crease medial side of Palmaris longus tendon.
All patients will be evaluated by Boston questionary and electro diagnostic parameters before, 1 month and 3 month after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010831833N1
Registration date:2017-02-19, 1395/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Zahra Azimi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 9604
Email address
z_azimi@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-09-29, 1395/07/08
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of corticosteroid injection with and without sonography guide in electro-diagnostic and clinical findings of patients with carpal tunnel syndrome
Public title
Effect of corticosteroid injection in treatment of carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
patients with CTS symptomes; positive tinnel, phalen and compression tests; who had moderate to severe CTS according to electrodiagnostic criteria; refuse surgery; are older than 18 and accept to inject corticosteroid
exclusion criteria:
pregnancy; presence of metabolic disorders that cause secondary CTS such as diabetes mellitus, thyroid disease; chronic kidney disease; rheumatological disorders; wrist fractures; having had corticosteroid injection before the study; conditions mimicking CTS such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome; having had physical or medical therapy in the previous month; having had previous wrist surgery; having thenar muscle atrophy; patient refusal to continue the follow-ups.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Science Ethics Committee
Street address
Gostaresh building, Isfahan University of Medical Science, Hezar jerib St.,
City
Isfahan
Postal code
Approval date
2016-09-28, 1395/07/07
Ethics committee reference number
IR.MUI.REC.1395.3.625
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
Symptom Severity Scale
Timepoint
befor, 1and 3 months after
Method of measurement
questionary
2
Description
Functional Status Scale
Timepoint
befor, 1and 3 months after
Method of measurement
questionary
3
Description
median nerve sensory latency
Timepoint
befor, 1and 3 months after
Method of measurement
EDX study
4
Description
median nerve motor latency
Timepoint
befor, 1and 3 months after
Method of measurement
EDX study
Secondary outcomes
1
Description
grade
Timepoint
before, 1 and 3 months after
Method of measurement
EDX study
2
Description
sensory NCV
Timepoint
before, 1 and 3 months after
Method of measurement
EDX study
3
Description
SNAP amp
Timepoint
before, 1 and 3 months after
Method of measurement
EDX study
4
Description
CMAP amp
Timepoint
before, 1 and 3 months after
Method of measurement
EDX study
5
Description
side effects
Timepoint
imediate, 1 and 3 months after
Method of measurement
questionary
Intervention groups
1
Description
depomedrol injection ultrasound guided
Category
Treatment - Other
2
Description
blind depomedrol injection
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
َAlzahra Hospital
Full name of responsible person
Dr. Zahra Azimi
Street address
Soffeh st.
City
Isfahan
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Dr. Zahra Azimi
Street address
Ayatollah Kashani St.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr. Mansoor Siavash
Street address
Vice-chancellery for research, Medical school, Hezar jerib st.
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 Science
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
Physical Medicine and Rehabilitation department
Full name of responsible person
Dr.Zahra Azimi
Position
Physical Medicine and Rehabilitation resident
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3688 5555
Fax
Email
z_azimi@edc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical Medicine and Rehabilitation department
Full name of responsible person
Dr.Zahra Azimi
Position
Physical Medicine and Rehabilitation resident
Other areas of specialty/work
Street address
Azahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3688 5555
Fax
Email
z_azimi@edc.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Physical Medicine and Rehabilitation department
Full name of responsible person
Dr.Zahra Azimi
Position
Physical Medicine and Rehabilitation resident
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3688 5555
Fax
Email
z_azimi@edc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)