patients with severe carpal tunnel syndrome, referred to outpatient clinics of physical medicine and rehabilitation affiliated to Isfahan University of Medical Sciences (2012-2013). Inclusion criteria consist of patients with signs and symptoms of CTS aged ≥18 years؛ and electrodiagnostic evidences of severe CTS. Exclusion criteria consist of Patients with secondary causes of CTS؛ conditions affecting treatment outcomes؛ as well as patients with thenar muscles atrophy due to advanced CTS. patients are selected by the simple random sampling method and are randomly allocated in two intervention groups (A and B).The sample size is estimated total number of 56 patients and 28 patients in each group. One group of patients (group A) is prescribed to use full time neutral wrist splint for a 12 weeks period. Group B is injected with 40 mg Depomedrol and prescribed to use the full time neutral wrist splint during the study period for 12 weeks. F/U criteria consist of electrodiagnostic parameters, Boston Questionnaire (BQ), and patients' satisfaction. Baseline characteristics of the studying population are recorded using electrodiagnostic parameters, Boston Questionnaire and patients' satisfaction. Studying population are reevaluated using Boston Questionnaire and patients' satisfaction after 4 weeks and all of F/U criteria 12 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050622130N1
Registration date:2015-07-19, 1394/04/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-19, 1394/04/28
Registrant information
Name
Sayed Amir Ebrahim Mahmoodian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 3645
Email address
khosrawi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment of splinting and splinting plus local steroid injection outcomes in severe carpal tunnel syndrome
Public title
Effectiveness of splinting and local steroid injection in severe carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with signs and symptoms of CTS aged ≥18 years؛electrodiagnostic evidences of moderate to severe CTS.
Exclusion criteria: Patients with secondary causes of CTS (diabetes mellitus؛ thyroid dysfunction؛ malignancy؛ distal radius fracture؛ pregnancy)؛ conditions affecting treatment outcomes (cervical disc herniation؛ fibromyalgia؛ coexisting neuropathy؛ previous steroid injection into the affected wrist)؛ patients with thenar muscles atrophy due to advanced CTS.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Av.
City
Isfahan
Postal code
8174673461
Approval date
2013-05-01, 1392/02/11
Ethics committee reference number
392162
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
clinical and functional status
Timepoint
baseline, 4 weeks and 12 weeks later
Method of measurement
Boston Questionnaire
2
Description
electrodiagnostic findings
Timepoint
baseline and 12 weeks later
Method of measurement
electromyography instrument
3
Description
patients satisfaction
Timepoint
baseline, 4 weeks and 12 weeks later
Method of measurement
Likert scale
Secondary outcomes
1
Description
local steroid injection complications
Timepoint
after injection,4 weeks and 12 weeks later
Method of measurement
patients complaints and physical examination
Intervention groups
1
Description
One group (group A) is prescribed to use full time neutral wrist splint for 12 weeks.
Category
Treatment - Other
2
Description
In group B using sterilized method and a 25G needle, 40mg methylprednisolone acetate (Depomedrol) is injected to the wrist-flexon crease just ulnar to the palmaris longus tendon. The needle is introduced with a 30 ° angle. If the patient complains of pain and paresthesia in hand, the needle is withdrawn and re-positioned. Then patients are prescribed to use the full time neutral wrist splint during the study period for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra educational hospital
Full name of responsible person
Sayed Amir Ebrahim Mahmoodian
Street address
Alzahra hospital, Sofeh Av., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Nematbakhsh
Street address
Isfahan University of Medical Sciences, Hezar Jarib Av.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences, Medical faculty
Full name of responsible person
Dr. Sayed Amir Ebrahim Mahmoodian
Position
MD, Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Av.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
Dean@med.mui.ac.ir
Web page address
www.med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Medical faculty
Full name of responsible person
Dr. Sayed Amir Ebrahim Mahmoodian
Position
MD, Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Av.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
Dean@med.mui.ac.ir
Web page address
www.med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Medical faculty
Full name of responsible person
Dr. Sayed Amir Ebrahim Mahmoodian
Position
MD, Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Av.
City
Isfahan
Postal code
8174673461
Phone
+98 31 3668 8466
Fax
+98 31 3668 8597
Email
Dean@med.mui.ac.ir
Web page address
www.med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)