Compare the clinical efficacy of oral gabapentin and naproxen on the severity of bone and joint pain in brucellosis patients admitted in Imam Hossein hospitals of Shahroud on 2016-2017
Compare the clinical efficacy of oral gabapentin and naproxen on the severity of bone and joint pain in brucellosis patients
Design
In this research, 86 eligible patients referring to Imam Hossein Hospitalwere chosen purposefully and a code was allocated to each one of them. Then, patients were randomly (Using random quadrants blocks) divided into two control and intervention groups.
Settings and conduct
This study was performed as a randomized clinical trial among patients admitted to Imam Hossein Shahroud Hospital with brucellosis diagnosis.The study is a double blind clinical trial and the participants, the main investigator, the data collectors, and those who evaluate the outcome are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definitive diagnosis of brucellosis
There is no history of systemic disease (such as diabetes or thyroid disease), vascular diseases, coagulation problems (eg hemophilia), history of gastrointestinal bleeding and structural disorders (scoliosis and spondylolisthesis, etc.)
No neurological symptoms such as SLR and Cross-SLR, decreased tendin reflexes and decreased sensation in examination
Age range 15 to 65 years
Complaint of severe and Fairly intense bone and joint pain
Desire and satisfaction to enter the study
Exclusion criteria:
Corticosteroid injections in the lumbar region or other areas of the body within 3 months before and during the study
Dissatisfaction to continue treatment
Those who use drugs
A history of back pain or repetitive back pain is more than 4 times a year
Taking multiple medications for other illnesses (such as hypnotics, anti-leptic, relaxants)
Severe hypersensitivity to any of the two drugs, gabapentin and naproxen
Dissatisfaction with cooperation and participation in the project
Compare the clinical efficacy of oral gabapentin and naproxen on the severity of bone and joint pain in brucellosis patients admitted in Imam Hossein hospitals of Shahroud on 2016-2017
Public title
Compare the clinical efficacy of oral gabapentin and naproxen on the severity of bone and joint pain in brucellosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of brucellosis
There is no history of systemic disease (such as diabetes or thyroid disease), vascular diseases, coagulation problems (eg hemophilia), history of gastrointestinal bleeding and structural disorders (scoliosis and spondylolisthesis, etc.)
No neurological symptoms such as SLR and Cross-SLR, decreased tendin reflexes and decreased sensation in examination
Age range 15 to 65 years
Complaint of severe and Fairly intense bone and joint pain
Desire and satisfaction to enter the study
Exclusion criteria:
Corticosteroid injections in the lumbar region or other areas of the body within 3 months before and during the study
Dissatisfaction to continue treatment
Those who use drugs
A history of back pain or repetitive back pain is more than 4 times a year
Taking multiple medications for other illnesses (such as hypnotics, anti-leptic, relaxants)
Severe hypersensitivity to any of the two drugs, gabapentin and naproxen
Dissatisfaction with cooperation and participation in the project
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple; the randomization unit is individual; the randomization tool of the Envelope is blocked; the method of constructing the random sequence of the quadrilateral block; the allocation concealment is using a blocked envelope, each containing a control or intervention group
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double blind clinical trial and the participants, the main investigator, the data collectors, and those who evaluate the outcome are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2016-07-26, 1395/05/05
Ethics committee reference number
IR.SHMU.REC.1395.72
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23.9
ICD-10 code description
Brucellosis, unspecified
Primary outcomes
1
Description
Intensity of pain
Timepoint
On the third, fifth and seventh day after the intervention