We want to evaluate the therapeutic effect of oral prednisolone in treatment of cervical radiculopathy in a double blind, randomized, placebo controlled trial. We will choose our target sample from those who suffered from cervical radiculopathy. Inclusion criteria are: 1-age 18-60 years. 2- Neck and arm pain for 2 weeks till 1 month. 3- Neck disability index (NDI) at least 15. 4- No chronic use of corticosteroid in past. Exclusion criteria will be: 1- normal EMG after 1 month. 2- happening any adverse effect of corticosteroid or any condition that cause contraindication to use corticosteroid such as pregnancy or hepatic failure. We will choose 2 groups of 30 patients relevant to cervical radiculopathy clinical findings and then we will give them acetaminophen 325 milligram in divided dose to both groups. Tablet of prednisolone 50 milligram for 5 days will be given to one group and then will be tapered. NDI and VRS (visual rating scale) will be calculated before and one week after intervention. We proposed cervical pain as primary subsequent and corticosteroid side effects as secondary one.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801211804N1
Registration date:2010-10-23, 1389/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-23, 1389/08/01
Registrant information
Name
Majid Ghasemi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
m_ghasemi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of therapeutic effect of oral prednisolone in compression of placebo in cervical radiculopathy treatment
Public title
Evaluation of prednisolone efficacy in the treatment of cervical radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1- Age 60-18 years. 2- Arm and neck pain consistent with cervical radiculopathy. 3- Neck disability scale (NDI) at least 15 (moderate disability). 4- The onset of symptoms between 2 weeks to 1 month. 5- No chronic use of corticosteroid. 6- No a history of previous surgery of cervical spine. Exclusion criteria: 1- Patients with immunosupression. 2- Red flag of tumor and clinical infection. 3- Symptoms of myelopathy. 4- Liver failure. 5- Schizophrenia. 6- Pregnancy and lactation. 7- Diabetes. 8- Osteoporosis. 9- Glaucoma. 10- Peptic ulcer. 11- Normal EMG after one month.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Isfahan university of medical sciences
Street address
Hezar jarib St.
City
Isfahan
Postal code
Approval date
2010-05-15, 1389/02/25
Ethics committee reference number
289006
Health conditions studied
1
Description of health condition studied
cervical radiculopathy
ICD-10 code
G55.2
ICD-10 code description
Nerve root and plexus compressions in spondylosis
Primary outcomes
1
Description
pain
Timepoint
week
Method of measurement
NDI (neck disability index) and VRS (visual rating scale)
Secondary outcomes
1
Description
drug side effect
Timepoint
week
Method of measurement
patient report
Intervention groups
1
Description
First group: Acetaminophen 325 milligram in 3 doses daily and Prednisolone 50 milligram oral, daily for 5 days and then will be tapered in 5 days
Category
Treatment - Drugs
2
Description
Second group: Acetaminophen 325 milligram in 3 doses daily and placebo for 5 days and then will be tapered in 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
neurology clinic of Kashani hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Majid Ghasemi
Street address
Kashani hospital
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
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
Full name of responsible person
Majid Ghasemi
Position
faculty member
Other areas of specialty/work
Street address
Kashani hospital
City
Isfahan
Postal code
Phone
+98 31 1235 0004
Fax
Email
m_ghasemi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Majid Ghasemi
Position
faculty member
Other areas of specialty/work
Street address
Kashani hospital
City
Isfahan
Postal code
Phone
+98 31 1235 0004
Fax
Email
m_ghasemi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Majid Ghasemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)