Protocol summary

Summary
This single blind Randomized Clinical Trial was designed to compare the effects of Corticosteroid versus Progesterone injection in patients with idiopathic mild to moderate Carpal Tunnel Syndrome. A total of sixty patients will be randomly assigned into 2 groups,group A and group B.Group A was treated with a single injection of 1 ml of triamcinolon and group B with 1 ml 17 alpha hydroxiprogesterone . Both groups used prefabricated hand wrist splint for CTS for 8 weeks. Pain visual analog scale (VAS), (BQ-SYMPT) Bostone/Levine symptom severity scale and Bostone/Levine functional status scale(BQ-FUNC) and EDX studys will be assessed before intervention, 10 weeks and 6 months after the intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013101313442N4
Registration date: 2013-11-01, 1392/08/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-01, 1392/08/10
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical Medicine and Rehabilitation Departement of Shahid Beheshti University of Medical Sience.
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-10-02, 1392/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of local Progesterone injection versus Corticosteroid injection in patients with mild and moderate Carpal Tunnel Syndrome in Physical Medicine and Rehabilitation clinic of Modarres and shohadaie Tajrish Hospitasls from 2012 to 2013
Public title
Effects of local Progesterone injection versus Corticosteroid injection in patients with Carpal Tunnel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: patient with mild and moderate CTS confirmed by the presence of 1 or more of the following standard electrophysiological criteria:1- prolonged distal motor latency (DML) (abnormal ≥4.2 ms)of Median nerve and 2) prolonged antidromic distal sensory latency (DSL) to the third digit (abnormal >3.6 ms; age between 20 to 65 years old. Exclusion criteria:Pregnancy; Severe degree CTS; Background metabolic diseases such as: Diabetes mellitus; Hypothyroidism; Rheumatoid arthritis; Previous history of Corticosteroid injection in Carpal Tunnel; Severe atrophy of Thener muscles; cervical radiculopathy or significant polyneuropathy; Unwillingness to participate in the present study; patient younger than 20 or older than 65 years old.
Age
From 20 years old to 65 years old
Gender
Female
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
Ethic committe of faculty of Medicine,Shahid Beheshti University of Medical siences
Street address
Shahid Beheshti University of Medical siences, next to Taleghani Hospital, yaman street, Chamran Highway
City
Tehran
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
400/8770

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
Pain
Timepoint
0,10 weeks, 6 months
Method of measurement
Visual Analog Scale, that is from 0-10 and zero (0) means that you did not have any pain and ten (10) means that you had the worst pain imaginable

2

Description
Functional Status
Timepoint
0, 6weeks, 6months
Method of measurement
Bostone/levine Functional Status Scale Questionnare

3

Description
Symptome Severity(pain and paresthesia)
Timepoint
0,10weeks, 6months
Method of measurement
Bostone/levine Symptome Severity Scale Questionnare

4

Description
Distal Sensory Peak Latency(SNAP) of median nerve
Timepoint
0,10weeks, 6months
Method of measurement
EDX Indexes

5

Description
Distal Motor Onset Latency(CMAP) of median nerve
Timepoint
0,10weeks, 6months
Method of measurement
EDX indexes

Secondary outcomes

1

Description
Patient Satisfication after trearment
Timepoint
0,10weeks, 6months
Method of measurement
Patient statement

Intervention groups

1

Description
Single injection of 1 ml of Triamcinolon with 2cc syringe and Prefabricated hand wrist splint for CTS for 8 weeks
Category
Treatment - Drugs

2

Description
Single injection of 1 ml 17 Alpha Hydroxiprogesterone with 2cc syringe and Prefabricated hand wrist splint for CTS for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Shadi Shahraeeni
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street
City
Tehran

2

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Shadi Shahraeeni
Street address
Shahrdari street, Tajrish square, Shohada Tajrish Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Medicine and Rehabilitation Departement of Shahid Beheshti University of Medical Science
Full name of responsible person
Vice chancellor for research, Seyed Ahmad Raeissadat
Street address
Physical Medicine and Rehabilitation Departement, Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicine and Rehabilitation Departement of Shahid Beheshti 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
Modarres Hospital
Full name of responsible person
Shadi Shahraeeni
Position
Physical Medicine and Rehabilitation resident
Other areas of specialty/work
Street address
Shahid Modarres hospital, Kaj square, Saadat abad street
City
Tehran
Postal code
Phone
+98 21 2207 4090
Fax
Email
dr.shahraeeni@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Modarres Hospital, Kaj square, Saadat Abad street
City
Tahran
Postal code
Phone
+98 21 2207 4090
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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