Low back pain (LBP) is one of the most common reasons for seeking medical care. In this study we want to evaluate the effect of spinal manipulation on tibial H-reflexes in patients with low back pain. Manipulation is one of the treatments for low back pain. Fifty-two patients 20-60 years old with low back pain without exclusion criteria (osteoporosis, history of previous surgery, pregnancy ) enrolled. Initially, the H-reflex is recorded and then lumbosacral manipulation is done for them, without the patient being moved, H-reflex is recorded. The results of H reflex amplitude and latency are compared before and after manipulation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203069222N1
Registration date:2012-08-17, 1391/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
Mohaddeseh Azadvari
Name of organization / entity
Army University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8350
Email address
dr_azadvari@mut.ac.ir
Recruitment status
Recruitment complete
Funding source
Army University of Medical Sciences
Expected recruitment start date
2012-01-03, 1390/10/13
Expected recruitment end date
2013-01-03, 1391/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lumbosacral manipulation on the tibial H-reflex
Public title
Effect of lumbosacral manipulation on the tibial H-reflex
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: patients with low back pain 20-60 years old
Exclusion criteria:neoplasm; major disease such as cardiac, renal; destructive vertebra diseases; vertebra Fx or dislocation; qudaeqina syndrome; past surgical history of vertebra; osteoprosis; BMI>32; Peregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Army University of Medical Sciences
Street address
Shahid Etemadzade Street, Western Fatemi Street, Tehran
City
Tehran
Postal code
14185611
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
9103
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
Amplitude tibial H reflex
Timepoint
before & after intervention
Method of measurement
With EDX study
Secondary outcomes
1
Description
Distal latency tibial H reflex
Timepoint
before & after intervention
Method of measurement
with EDX study
Intervention groups
1
Description
lumbosacral manipulation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
501 Army Hospital
Full name of responsible person
Dr Azadvari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr Rezaee Moghaddam
Street address
Shahid Etemadzade Street, Western Fatemi Street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Army 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
501 Army Hospital
Full name of responsible person
Mohaddeseh Azadvari
Position
Resident of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Shahid Etemadzade Street, Western Fatemi Street.
City
Tehran
Postal code
Phone
+98 21 8802 8350
Fax
Email
drazadvari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Mohaddeseh Azadvari
Position
Resident of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Shahid Etemadzade Street, Western Fatemi Street.
City
Tehran
Postal code
Phone
+98 21 8802 8350
Fax
Email
drazadvari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Mohaddeseh Azadvari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
drazadvari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)