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
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