clinical trial comparing the effect of oral piroxicam and subcotaneus injection of piroxicam(mesotherapy) on improvement of pain and function in patients with knee osteoarthriris.
target:evaluation of the effectiveness of mesotherapy in decreasing pain and improvement of the function in40-70y/o patient with knee osteoarthritis.inclusion criteria:mild to moderate disease;exclusion criteria:DM,rheumatic disease,pregnancy,knee injection in recent 3month;sample size:60cases;intervention:subcotaneus injection of 20mg injection in knee in first group and prescribtion of 20mg of oral piroxicam for 10days in second group and follow up patients For 2 and 4weeks after intervention;time of study:shahrivar 96-khordad 97(september 2017-may2018).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052434113N1
Registration date:2017-09-19, 1396/06/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
fahime estakhri
Name of organization / entity
shiraz university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 9040
Email address
estakhrif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial comparing the effect of oral piroxicam and subcotaneus injection of piroxicam(mesotherapy) on improvement of pain and function in patients with knee osteoarthriris.
Public title
effectiveness of subcotaneous injection of piroxicam compared with oral use of piroxicam in pain improvement in patients with knee osteoarthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:40-70y/o patients with mild to moderate osteoarthritis with clinical symptoms at least recent 1month;
exclusion criteria:disease suchvas:DM,collagen vascular and rheumatism,gout,neuropathy,radiculopathy,nerve injury,brucella,BMI>42,trauma ,bleeding tendency,significant hepatic,renal and cardiopulmonaryproblems,knee arthroplasty,allergy to piroxicam,knee injection in recent 3month,pregnancy,cancer,cognitive disorders.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized method:patients with similar sex,age,job,life style and comorbidities put in 2 groups;this study is single blind(blind for information analysts at the end of the study).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shiraz university of medical sciences
Street address
shiraz,zand street,opposite of felestin street ,the central building
before intervention,2 and 4 weeks after intervention
Method of measurement
VAS,WOMAC,AXFORD questionnaires
Intervention groups
1
Description
group1intervention:subcotaneus injection of 20mgpiroxicam with 5cc lidocain2% around knee,repeat 10days later,life style modification and knee exercise.
Category
Treatment - Drugs
2
Description
group 2 intervention:oral use of 20 mg piroxicam for 10 days,life style modification,exercise for knee.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
hafez hospital
Full name of responsible person
fahime estakhri
Street address
shiraz,bolvare chamran,after social security organization
City
shiraz
2
Recruitment center
Name of recruitment center
rajaee hospital
Full name of responsible person
fahime estakhri
Street address
shiraz chamran near to niyayesh
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of shiraz university of medical science
Full name of responsible person
vice chancellor for research of shiraz university of medical science
Street address
shiraz, zand street ,medical college of shiraz university
City
shiraz
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 of shiraz university of medical science
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
shiraz university of medical science
Full name of responsible person
fahime estakhri
Position
physiatry resident
Other areas of specialty/work
Street address
shiraz ,zand street,felestin street,central office of shiraz university of medical science
City
shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
estakhrif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
shiraz university of medical science
Full name of responsible person
fahime estakhri
Position
physiatry resident
Other areas of specialty/work
Street address
shiraz,zand street,opposite of felestin street,central office of shiraz university of medical science
City
shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
estakhrif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
shiraz university of medical science
Full name of responsible person
fahime estakhri
Position
physiatry resident
Other areas of specialty/work
Street address
shiraz,zand street,opposite of felestin street,central office of shiraz university of medical science
City
shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
estakhrif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)