1.Determine and compare the mean and median VAS score before treatment between the comparison and intervention groups
2. Determination and comparison of mean and median VAS score one and three months after treatment between comparison and intervention groups
3. Determination and comparison of pre-treatment disability score between comparison and intervention groups
4.Determine and compare the disability score one and three months after treatment between the comparison and intervention groups
5. Comparison of mean and median VAS score before and one and three months after treatment in the comparison group
6. Comparison of disability score before and one and three months after treatment in comparison group
Design
A randomized controlled clinical trial with parallel groups, without blinding
Settings and conduct
This study was performed in patients with chronic low back pain referred to physical medicine clinic of Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria are:1. People over 5 years old with low back pain
2.2. Lack of back pain for more than 2 weeks and no treatment in the last month.
3.Patients have never had lumbar surgery.
Intervention groups
Patients included in this study were randomly divided into two groups of intervention and comparison. One group of patients is treated with drug and exercise and shockwavesham, and the other group is treated with shockwave in addition to medicine and exercise. We use 4Hz frequency and 0.15 joule energy is applied to the painful areas of the gluteal and paraaspinal muscles. This modality is administered once a week for four weeks to the patient.
Main outcome variables
Mean VAS score; disability score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191021045171N1
Registration date:2019-12-04, 1398/09/13
Registration timing:retrospective
Last update:2019-12-04, 1398/09/13
Update count:0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Mitra ramezany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9135
Email address
mitra.ramezany@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-01, 1396/03/11
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
2017-06-01, 1396/03/11
Actual recruitment end date
2018-03-01, 1396/12/10
Trial completion date
2018-03-01, 1396/12/10
Scientific title
The effects of Extra corporeal shock wave therapy on pain and disability of chronic low back paining patients
Public title
Extra corporeal shock wave therapy for chronic Low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.Low back pain for more than 12 weeks and no treatment in the last month, 2.Patients have never had lumbar surgery, 3.Do not have mental or cognitive illness, 4.Don't be pregnant, 5.No structural spine diseases, 6.No current fracture or history of vertebral fracture, 7.Absence of spinal cord tumor, 8.Absence of vertebral or intervertebral disc infections, 9.Absence of inflammatory diseases such as rheumatoid arthritis, 10.Absence of nerve symptoms caused by intervertebral disc herniation and 11.Do not have a coagulation disorder.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization method will be randomly divided into intervention and comparison groups using Random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan city
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.MUI.REC.1395.3.978
Health conditions studied
1
Description of health condition studied
Chronic low back pain and disability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Chronic lower back pain
Timepoint
Before and after treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group are treated with medicine, exercise and shock wave therapy. Shock wave therapy sessions are four (weekly) and in each session patients are received 1500 shocks with 4 Hz frequency on Gluteal and Paraspinal muscles.
Category
Rehabilitation
2
Description
Control group: Patients in this group are treated with medicine, exercise and shock wave sham therapy. Shock wave sham therapy sessions are four (weekly) and in each session patients are received sham shock waves on Gluteal and Paraspinal muscles.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mitra Ramazani
Street address
Alzahra hospital, Shohadaye Sofeh Street, Isfahan city
City
Isfahan
Province
Isfehan
Postal code
817746-73461
Phone
+98 31 3668 0048
Email
mitra.ramezany@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
817746-73461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mitra Ramezany
Position
Specialist physician
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mitra.ramezany@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
prs-taheri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mitra Ramezany
Position
Non-academic specialist physician
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 9135
Fax
Email
Mitra.ramezany@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the original outcome or the like, can be shared.
When the data will become available and for how long
2020
To whom data/document is available
Everyone
Under which criteria data/document could be used
Mann-Whitney Repeated Repeated Measures of ANOVA tests were performed
From where data/document is obtainable
Through the responsible author
What processes are involved for a request to access data/document