To assess the effect of extracorporeal shockwave versus control group on pain and disability of chronic low back pain
Design
This is a Phase III randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan city, involving 56 eligible patients with chronic low back pain. The patients will be randomly assigned to the intervention and control groups through the block randomization. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Chronic lower back pain for more than 12 weeks
Exclusion criteria:
Pregnancy
History of back surgery
Mental and cognitive illness
Fracture or tumor or infection of the lumbar vertebrae
Coagulation disorders
Intervention groups
Intervention group:
Tizanidine tablets, 1 mg for the first 2 nights, then 2 mg for 10 days, and Meloxicam tablets, 15 mg daily for 2 weeks, in addition to extracorporeal shock wave using a 1500 focus probe with a frequency of 4 Hz and an energy of 0.15 J once a week for four weeks
Control group:
Tizanidine tablets, 1 mg for the first 2 nights, then 2 mg for 10 days, and Meloxicam tablets, 15 mg daily for 2 weeks
Main outcome variables
Primary outcome:
The mean score of pain, the mean score of disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N508
Registration date:2024-05-01, 1403/02/12
Registration timing:prospective
Last update:2024-05-01, 1403/02/12
Update count:0
Registration date
2024-05-01, 1403/02/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of extracorporeal shockwave versus control group on pain and disability of chronic low back pain: a randomized clinical trial
Public title
Effects of extracorporeal shockwave versus control group on pain and disability of chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Chronic lower back pain for more than 12 weeks
Exclusion criteria:
Pregnancy
History of back surgery
Mental and cognitive illness
Fracture or tumor or infection of the lumbar vertebrae
Coagulation disorders
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.UMSHA.REC.1403.030
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
The mean score of pain
Timepoint
Before the intervention and one and three months later
Method of measurement
Using Visual Analog Scale (VAS)
2
Description
The mean score of disability
Timepoint
Before the intervention and one and three months later
Method of measurement
Using Oswestry questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tizanidine tablets, 1 mg for the first 2 nights, then 2 mg for 10 days, and Meloxicam tablets, 15 mg daily for 2 weeks, in addition to extracorporeal shock wave using a 1500 focus probe with a frequency of 4 Hz and an energy of 0.15 J once a week for four weeks
Category
Treatment - Other
2
Description
Control group: Tizanidine tablets, 1 mg for the first 2 nights, then 2 mg for 10 days, and Meloxicam tablets, 15 mg daily for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Mobin Alvandi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
mobinalvand@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mobin Alvandi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mobinalvand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Nikta Nikbakht
Position
Physical Medicine Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
drniktanikbakht@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available