Comparing the efficacy of local injection of methylprednisolone and lidocaine with and without splint, with splint making only in treating patients with De quervan tenosynovitis.
The present study aimed at comparing the efficacy of local injection of methylprednisolone and lidocaine with and without splint, with splint making only ( without injected drug ) in treating patients suffered from De quervan tenosynovitis.The patients in this study were referred to orthopedic clinics affiliated with medical sciences university of Shahrekord in 2010. In a clinical trial study, 108 patients with De quervan tenosynovitis were selected as samples. These patients had all inclusion criteria such as complete consent for participating in the study, cooperating with physician, and acting based on his prescriptions. The patients suffered from diabetes, addicted to narcotics, interrupted the treatment and those who were deaf and mute were excluded from this study. Then, the patients were randomly divided into three groups. At the beginning of the study ,therapeutic intervention for the first group was injected 1ml of %1 lidocaine and 40 mg of metylprednisone with splint. The second group was injected 1ml of %1 lidocaine with 40 mg of metylprednisone and the third group was treated with splint only ( without injected drug ). All three groups followed for three weeks after intervention. The primary outcome was reduction in the mean time to recurrence of symptoms and Average pain intensity as reported by questionnaire, visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903164089N2
Registration date:2011-07-08, 1390/04/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-08, 1390/04/17
Registrant information
Name
Shahriar Salehitali
Name of organization / entity
Shahrekored medical university
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
sh_salehi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekored University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2009-10-23, 1388/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of local injection of methylprednisolone and lidocaine with and without splint, with splint making only in treating patients with De quervan tenosynovitis.
Public title
Comparing the efficacy of local injection of methylprednisolone and lidocaine with and without splint, with splint making only in treating patients with De quervan tenosynovitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion/criteria :
complete consent for participation in research project, on-time reference to doctor, complete observation of doctor’s prescriptions.
exclusion/criteria:
Being diabetes, being deaf and mute, interrupting the treatment, being addicted to narcotics
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekored University of Medical Sciences
Street address
Shahrekored University of Medical Sciences
City
Shahrekored
Postal code
8813833435
Approval date
2008-09-23, 1387/07/02
Ethics committee reference number
2-7-87
Health conditions studied
1
Description of health condition studied
tendon inflamation
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain
Primary outcomes
1
Description
PAIN
Timepoint
WEEKLY
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
reduce using analgegic drug
Timepoint
weekly
Method of measurement
verbalization
2
Description
reduce to refer physician
Timepoint
follow up
Method of measurement
verbalization
Intervention groups
1
Description
Injected a dose rate of 1% lidocaine 1 cc and 40 mg methylprednisolone with splint and follow for 3 weeks
Category
Treatment - Drugs
2
Description
Injected a dose rate of 1% lidocaine 1 cc and 40 mg methylprednisolone and follow for 3 weeks
Category
Treatment - Drugs
3
Description
Fixed joints with splint and follow for three weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
kashani hospital affiliated shahrekored medical universty
Full name of responsible person
shahriar salehi
Street address
kashani.st. medical university.shahrekored
City
shahrekored
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekored University of Medical Sciences
Full name of responsible person
shahriar salehi
Street address
shahrekored .kashani street . medical university.
City
shahrekored
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekored 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
Shahrekored University of Medical Sciences
Full name of responsible person
shahriar salehi
Position
Academic member.master of science (Msc)
Other areas of specialty/work
Street address
Kashani st.,
City
Shahrekored
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
sh_saehi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekored University of Medical Sciences
Full name of responsible person
Shahriar Salehi
Position
Academic member.master of science (Msc)
Other areas of specialty/work
Street address
Rahmatieh, Faculty of Nursing and Midwifery .shahrekored
City
shahrekored
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
sh_salehi@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekored University of Medical Sciences
Full name of responsible person
Shahriar Salehi
Position
Academic member.master of science (Msc)
Other areas of specialty/work
Street address
Rahmatieh, Faculty of Nursing and Midwifery
City
shahrekored
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
sh_salehi2skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)