Determination and Comparison of clinical effectiveness of ketorolac and triamcinolone injection in patients with moderate carpal tunnel syndrome patients
Design
Clinical trials without control group, with parallel groups, double blind,randomized,Sample size 45person,60wrists
Settings and conduct
The sample included patients referred to the Physical Medicine Clinic of Imam Reza Hospital, Tabriz, Iran. The diagnosis of carpal tunnel syndrome with electrodeagenesis was given to them. All patients referred to the Imam Reza and Madani Hospital in Tabriz, who are referred to the Medical Physics Department of the Carpal Tunnel Syndrome Diagnosis, are measured by the hand dynamometer. Boston's carpal tunnel questionnaire (BCTQ) is also used for evaluation. The severity of carpal tunnel syndrome will be performed. In this study patients will be divided into two groups and will be injected for a triamcinolone group and for another group of ketorolacs by an experienced physician and rehabilitation specialist. Then, a three-month Boston functional questionnaire will be provided to the patients and the information will be compared.
After the patient's illness and explanation, the patient's informed consent is divided into two groups, and the attendant's caregivers perform the necessary services for the patients according to the order of the investigator.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having moderate carpal tunnel syndrome criteria Exclusion criteria: atrophy of thenar muscle and no desire for surgery
Intervention groups
Intervention group 1: Ketorolac recipient group Intervention group 2: Triamcinolone recipient group
Main outcome variables
Changes in Boston Questionnaire; Changes in latency and amplitude of Median Nerve Sensory and Motor Action Potential; Wrist Strength Changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190326043118N1
Registration date:2019-09-17, 1398/06/26
Registration timing:retrospective
Last update:2019-09-17, 1398/06/26
Update count:0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
amirreza ghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3542 2706
Email address
amirrezaghanbari1372@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-14, 1398/01/25
Expected recruitment end date
2019-04-25, 1398/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical effectiveness of ketorolac and Triamcinolone injection in patients with moderate to severe carpal tunnel syndrome
Public title
Comparison of clinical effectiveness of ketorolac and Triamcinolone injection in patients with moderate to severe carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proof of Carpal Tunnel Syndrome Moderate with STEVENS Electrodiogenesis Criteria
CMAP latency>4.2msec
SNAP latency>3.0msec
SNAP latency>3.0msec+low amplitude SNAP
NCV across wrist<40m/sec
CMAP Amplitude <4mv with SNAPs amplitude <12uv without symptoms of degeneration (fib / psw) in tension in Nidal EMG
Exclusion criteria:
Symptoms of atrophy of the tenar
Contraindication of corticosteroid injection such as corticosteroid hypersensitivity and injection site infection
Treatment of carpal tunnel syndrome with surgery or corticosteroid injection over the past 6 months
Traumatic or neoplastic origin of symptoms
No consent for injection
Symptoms of denervation in electromyography suggestive of severe axonal injury
Symptoms of active cervical radiculopathy in electromyography or cervical disc protrusion in MRI
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
2
Patients who were involved bilaterally received both wrists and And only one hand was involved in patients with one wrist involved.Finally, 45 patients and 60 wrists were studied
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
After randomization and informed patient satisfaction, each patient is randomly assigned a number that is paired for triamcinolone injection and individual for ketorolac injection.Clinical care according to numbers will inject one of the drugs for the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central Office of the University of Medical Sciences,Golgasteh Street , Azadi Avenue , TABRIZ
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-08-21, 1398/05/30
Ethics committee reference number
IR.TBZMED.REC.1398.564
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
Total score of Carpal Tunnel Syndrome Questionnaire Boston To measure severity of symptoms and dysfunction
Timepoint
Before intervention and 3 months later
Method of measurement
boston carpal tunnel questionnaire
Secondary outcomes
1
Description
hand power
Timepoint
Before intervention and 3 months later
Method of measurement
hand dynamometer
Intervention groups
1
Description
Intervention group 1: Ketorolac group 30 mg Alborz Daru group injected under ultrasound guide ide
Category
Treatment - Drugs
2
Description
Intervention group2: Triamcinolone group 40 mg manufactured by Iran hormone injected under ultrasound guide
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Emam Reza
Full name of responsible person
Alireza Pishghahi
Street address
Department of Physical Medicine and Rehabilitation,Imam Reza Hospital, University Square, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138636762
Phone
+98 41 3542 2706
Email
Alirezapishgahi1364@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samii
Street address
Department of Physical Medicine and Rehabilitation,Imam Reza Hospital, Golshat Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138636762
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
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, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amirreza Ghanbari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Department of Physical Medicine and Rehabilitation,Imam Reza Hospital, Golshat Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138636762
Phone
+98 41 3542 2706
Email
amirrezaghanbari1372@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Pishghahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation,Imam Reza Hospital, Golshat Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138636762
Phone
+98 41 3336 1928
Email
Alirezapishgahi1364@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Pishghahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation,Imam Reza Hospital, Golshat Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138636762
Phone
+98 41 3336 1928
Email
Alirezapishgahi1364@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available