Comparison of the effect of static and dynamic splints on pain and functional abilities of hand in women with De Quervain syndrome: a randomized clinical trial
Objectives: To assess the effect of static and dynamic splints on pain and functional abilities of hand in women with De Quervain syndrome.
Design: a randomized clinical trial.
Setting and conduct: The eligible women with De Quervain syndrome who will refer to School of Rehabilitation during the study period will be enrolled into the trial.
Inclusion criteria: Women with De Quervain syndrome; age of 18 to 25 years; ability to take objects; literate.
Exclusion criteria: history of hand surgery; hand deformity; skin problem in hand.
Intervention group 1: Fixing static splints on the hand for 6 months.
Intervention group 2: Fixing dynamic splints on the hand for 6 months.
Primary outcome: (a) measuring pain by standard questionnaire 6 months after intervention; (b) measuring inability by standard questionnaire 6 months after intervention.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702209014N144
Registration date:2017-03-06, 1395/12/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-06, 1395/12/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-03-17, 1395/12/27
Expected recruitment end date
2017-11-18, 1396/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of static and dynamic splints on pain and functional abilities of hand in women with De Quervain syndrome: a randomized clinical trial
Public title
Comparison of the effect of static and dynamic splints on pain and functional abilities of hand in women with De Quervain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with De Quervain syndrome; age of 18 to 25 years; ability to take objects; literate.
Exclusion criteria: history of hand surgery; hand deformity; skin problem in hand.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.500
Health conditions studied
1
Description of health condition studied
De Quervain syndrome
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
measuring pain
Timepoint
6 months after intervention
Method of measurement
by standard questionnaire
2
Description
measuring inability
Timepoint
6 months after intervention
Method of measurement
by standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Fixing static splints on the hand for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group 2: Fixing dynamic splints on the hand for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation
Full name of responsible person
Dr Farzad Farmani
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
School of Rehabilitation
Full name of responsible person
Dr Farzad Farmani
Position
Specialist in Orthosis and Prosthesis
Other areas of specialty/work
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
farmani.farzad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation
Full name of responsible person
Dr Farzad Farmani
Position
Specialist in Orthosis and Prosthesis
Other areas of specialty/work
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
farmani.farzad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)