This study aimed to evaluate the efficacy of oral gabapentine on pain intensity in patients with low back pain. This research is an interventional single-blind clinical trial study.
100 patients with acute low back pain, mild to moderate (less than 4 weeks) with age between 20 to 50 years attending clinics affiliated with the Shahrekord University of Medical Sciences by convenience sampling are divided in two identical groups, intervention and control groups. Both groups are treated two weeks using naproxen tablets(500mg) two times in a day.
In group 1, it is received gabapentine 100 mg 2 tablets daily, in group 2, placebo pills is prescribed. Patient characteristics in both groups including: demographic data, pain scores based on the Visual Analog Scale and patient performance including quality of public activity, mood, walking ability, social activities and sleep are recorded before the start of the study and on treatment days 8,15 30.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303096480N4
Registration date:2013-04-20, 1392/01/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-20, 1392/01/31
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research Affairs, Shahrekord University of Medical Sciences
Expected recruitment start date
2013-03-15, 1391/12/25
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To detect the efficacy of oral gabapentin on pain intensity in patients with acute low back pain patients
Public title
Efficacy of oral gabapentin on pain intensity in patients with acute low back pain patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. No systematic disease (diabetes or thyroid disease); infectious diseases(brucellosis and tuberculosis); vascular disease; clotting disorder(hemophilia); structural disorders ( scoliosis and Spondylolysthesis).
2. The neurologic symptoms (positive SLR, cross SLR, loss of tendon reflexes and sensation.
3. Aged between 20-24 years
4. Complained of acute pain (less than 4 weeks).
5. Patients’ willingness to participate in the study .
Exclusion criteria :
1-Corticosteroid injections in the back region or other parts of the body in the 3 months before the study and during the study.
2- No satisfaction to continue treatment.
3-INividuals who consume narcotic drugs
4- The history of recurring back pain for more than 4 times in a year.
5- Consumption multiple medications for other diseases sleep medications, relaxant, acetaminophen and NSAIDs).
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Kashani Blvd, Secretery of Shahrekord University of Medical Sciences, Deputy of Research Affairs
City
Shahrekord
Postal code
Approval date
2012-01-13, 1390/10/23
Ethics committee reference number
90-2-13
Health conditions studied
1
Description of health condition studied
acute back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 15th, 8th, 30th day after intervention
Method of measurement
VAS standard Questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Two weeks undertreatment by Naproxen tablets(500mg) twice each day and placebo daily two tabets
Category
Treatment - Drugs
2
Description
Interventional group: Two weeks undertreatment by Naproxen tablets(500mg)twice each day and Gabapentin(100mg) daily two talets
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Clinic of Ayatallah Kashani
Full name of responsible person
Dr Morteza Dehghan
Street address
Shariati Street
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellory for research, Shahrekord University of Medical Sciences
Full name of responsible person
Mahmoud Mobasheri
Street address
Kashani Blvd
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellory for research, Shahrekord 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
Shahrekord University OF Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Assistant Professor in Orthopedic Department
Other areas of specialty/work
Street address
Orthopedic Department
City
Shahrekord
Postal code
Phone
+98 38 1226 4835
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord university of Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Orthopedic Surgery
Other areas of specialty/work
Street address
Ayatallah Kashani Hospital
City
Shahrekord
Postal code
Phone
+98 38 1226 4835
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)