In this study we have designed a wrist limited dynamic splint for women with mild or moderate carpal tunnel syndrome which allow the wrist to extends up to 15 degrees and flexes up to 15 degrees. The trait of this splint allows the patient to have treatment and do their activities of daily living at the same time. The subjects of both treatment and control group will be received the routine treatment of rehabilitation but just the treatment group will receive the splints. The results of this study would be scores of Boston carpal tunnel syndrome questionnaire, grip and pinch strength, dexterity purdue peg board test, sensory conductive velocity and sensory distal latency of median nerve. These tests will be performed before and after the 6 weeks treatment.
General information
Acronym
WLDS for CTS
IRCT registration information
IRCT registration number:IRCT2015061522753N1
Registration date:2015-11-27, 1394/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-27, 1394/09/06
Registrant information
Name
Seyede Marjan Jaladat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 634 6493
Email address
m-jaladat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-06-19, 1394/03/29
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of wrist limited dynamic splint on the upper extremity function of women with carpal tunnel syndrome
Public title
Effects of wrist limited dynamic splint on carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the subjects gender should be female; the patients diagnosis should be carpal tunnel syndrome by a physiatrist doctor; the severity of illness should be mild or moderate; the subjects should be able to understand and do the orders of the tests.
Exclusion criteria: history of surgery on the affected hand; systemic illnesses; pregnancy; subjects who do not cooperate; subjects who do not have the results of neural conductive tests.
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Unversity of Medical Sciences
Street address
Tehran Unversity of Medical Sciences, Qhods St., Keshavars boulvard
City
Tehran
Postal code
1417614411
Approval date
2015-11-25, 1394/09/04
Ethics committee reference number
IR.TUMS.REC.1394.1272
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
Function
Timepoint
Before and after the 6 weeks treatment
Method of measurement
Boston carpal tunnel syndrome questionnaire
2
Description
Symptome severity
Timepoint
Before and after the 6 weeks treatment
Method of measurement
Boston carpal tunnel syndrome questionnaire
3
Description
Grip strength
Timepoint
Before and after the 6 weeks treatment
Method of measurement
MIE digital device
4
Description
Pinch strength
Timepoint
Before and after the 6 weeks treatment
Method of measurement
MIE digital device
5
Description
Dexterity
Timepoint
Before and after the 6 weeks treatment
Method of measurement
Purduepeg board test
6
Description
Median nerve sensory conductive velocity
Timepoint
Before and after the 6 weeks treatment
Method of measurement
MEDLEC SYNERGY VIASIS electromiography device
7
Description
Median nerve distal sensory latency
Timepoint
Before and after the 6 weeks treatment
Method of measurement
MEDLEC SYNERGY VIASIS electromiography device
Secondary outcomes
empty
Intervention groups
1
Description
The treatment group would receive routine rehabilitation treatment beside the wrist limited dynamic splint
Category
Rehabilitation
2
Description
the control group would receive routine rehabilitation treatment without splint