The purpose of this study was to evaluate the therapeutic effects of Wrist Splint in patients with carpal tunnel syndrome (CTS) treated with ibuprofen from EMG-NCV perspectives in patients referred to the Neurology Clinic of Vali-e-Asr hospital in Birjand. The sample size of this study is 40 people including 20 case and 20 control subjects. The main inclusion criteria for the study is having carpal tunnel syndrome and all patients with carpal tunnel syndrome caused by pregnancy, tumors and fractures (main exclusion criteria) will be excluded. The study duration is 6 weeks. Before and after the intervention the EMG-NCV study will be carried out on all patients in order to monitor the consequences of the study (including nerve conduction velocity, nerve conduction amplitude and nerve conduction latency) .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111018063N2
Registration date:2014-12-19, 1393/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Ali Rajabpour Sanati
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1067
Email address
ali.poursanati@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research - Birjand University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating Therapeutic effects of Wrist splint in terms of EMG-NCV in patients with Carpal Tunnel Syndrome (CTS) under treatment with Ibuprofen
Public title
Evaluating Therapeutic effects of Wrist splint in patients with Carpal Tunnel Syndrome under treatment with Ibuprofen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Personal consent for participation; not being pregnant or having pregnancy-induced carpal tunnel syndrome; not having carpal tunnel syndrome caused by trauma such as wrist fractures or tumor disorders; not suffering from spinal cord injuries or organic upper extremity disorders; no addiction; Exclusion criteria:Not willing for re-examination and performing laboratory tests; the inclusion of a specific organic pathology such as cancer, tumors, fractures, collagen vascular diseases such as RA, metabolic diseases such as diabetes, thyroid disorders, or other problems that interfere with the study
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
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
Birjand University of Medical Sciences
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Postal code
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
1393-06-02
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
G56
ICD-10 code description
Mononeuropathies of upper limb
Primary outcomes
1
Description
velocity of nerve conduction
Timepoint
before intervention - after intervention
Method of measurement
EMG-NCV
2
Description
amplitude of nerve conduction
Timepoint
before intervention - after intervention
Method of measurement
EMG-NCV
3
Description
latency (s) of nerve conduction
Timepoint
before intervention - after intervention
Method of measurement
EMG-NCV
4
Description
latency (m) of nerve conduction
Timepoint
before intervention - after intervention
Method of measurement
EMG-NCV
Secondary outcomes
empty
Intervention groups
1
Description
Control group:treated with Ibuprofen 800 mg twice a day for 6 weeks
Category
Treatment - Drugs
2
Description
Case group: treated with Ibuprofen 800 mg twice a day with wrist splint for 6 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr Hospital
Full name of responsible person
Ali Rajabpour Sanati
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research - Birjand University of Medical Sciences
Full name of responsible person
Dr. Zarban
Street address
Moallem Blvd, Birjand, Iran
City
Birjand
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 - Birjand University of Medical Sciences