Investigating immediate effects of posterior-anterior lumbar mobilization with different amplitude on pressure pain threshold of patients with chronic non specific low back pain
Investigating effects of posterior-anterior lumbar mobilization with different amplitude on pressure pain threshold of patients with chronic non specific low back pain
Design
A controlled clinical trial via cross-over grouping with 28 participants.
Settings and conduct
In the first session, the subjects were placed in the prone position for 5 minutes as the control group, and pressure pain threshold (PPT) was measured in the left middle Deltoid region, fourth lumbar dermatome, first sacrum dermatome, and 3 cm right side of the fourth lumbar vertebra .In therapy group, the subjects had posterior-anterior lumbar vertebrae mobilization technique with three high, low and relatively static amplitudes. PPT was measured before and after mobilization. To calculate force applied, we placed a weight gauge below the abdomen of patients.The study was performed in school of rehabilitation of Tehran university of medical science. Our study is not blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria: suffering chronic nonspecific low back pain,
Pain at the beginning of study between: 3-6 according to visual analog scale,
age ranges between 18 to 45 years,
Male participants only,
experiencing back pain for more than 3 months,
Body mass index below 28.
exclusion criteria: Existence of deviation in alignment of vertebral column,
Radiating pain from low back region to lower extremity
Intervention groups
therapy group 1: posterior-anterior mobilization lumbar spine with high amplitude
therapy group 2: posterior-anterior mobilization lumbar spine with low amplitude
therapy group3: posterior-anterior mobilization lumbar spine with static amplitude
We used Pisiform grip technique for lumbar mobilization in this study.
control group: first, participants sustained prone position for five minutes after that we performed assessment.
Main outcome variables
Pressure Pain Threshold
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190818044558N1
Registration date:2020-01-12, 1398/10/22
Registration timing:retrospective
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Mohammad reza Khanmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6662 4672
Email address
mr-khanmohammadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2016-08-15, 1395/05/25
Trial completion date
2016-08-15, 1395/05/25
Scientific title
Investigating immediate effects of posterior-anterior lumbar mobilization with different amplitude on pressure pain threshold of patients with chronic non specific low back pain
Public title
Manual therapy techniques in low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
suffering chronic nonspecific low back pain
Pain at the beginning of study between: 3-6 according to visual analog scale
age ranges between 18 to 45 years
Male participants only
experiencing back pain for more than 3 months
Body mass index below 28
Exclusion criteria:
Existence of deviation in alignment of vertebral column
Radiating pain from low back region to lower extremity
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Actual sample size reached:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Science main building, Kehavarz Blvd, Qods Ave,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-11-25, 1394/09/04
Ethics committee reference number
IR.TUMS.REC.1394.1274
Health conditions studied
1
Description of health condition studied
Chronic non-specific low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pressure pain threshold
Timepoint
Before and immediately after performing the therapy procedure
Method of measurement
Pressure algometry according to newton scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Fourth lumbar vertebra posterior-anterior mobilization with low amplitude (150-200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae. There was three different session of therapy.To prevent the carry-over effect, we implemented 48 hours rest between each session. To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study.
Category
Rehabilitation
2
Description
Intervention group2: Fourth lumbar vertebra posterior-anterior mobilization with high amplitude ( 50-200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae. There was three different session of therapy.To prevent the carry-over effect, we implemented 48 hours rest between each session.To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study.
Category
Rehabilitation
3
Description
Intervention group3: Fourth lumbar vertebra posterior-anterior mobilization with static amplitude (200 N). Patient were asked to go in prone position and after that the mobilization technique was applied to forth lumbar vertebrae. There was three different session of therapy. To prevent the carry-over effect, we implemented 48 hours rest between each session. To calculate precise amount of force applied, we placed a digital weight gauge below the abdomen of patients. We used Pisiform grip technique for lumbar mobilization in this study.
Category
Rehabilitation
4
Description
Control group: Sustaining prone position for five minutes
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, School of rehabilitation science
Full name of responsible person
Mohammad Reza Khanmohammadi
Street address
Mohammad Reza Khanmohammadi, No 33, Mirghaderi alley, Gozalkhoue Street, south Mehr-abad district, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1385666161
Phone
+98 21 6662 4672
Email
mr-khanmohammadi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraian
Street address
Tehran University of Medical Science main building, Kehavarz Blvd, Qods Ave,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khanmohammadi
Position
Graduated, Not a faculty member
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Mohammad Reza Khanmohammadi, No 33, Mirghaderi alley, Gozalkhoue Street, south Mehr-abad district, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1385666161
Phone
+98 21 6662 4672
Email
mr-khanmohammadi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khanmohammadi
Position
Graduated, not a faculty member
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Mohammad Reza Khanmohammadi, No 33, Mirghaderi alley, Gozalkhoue Street, south Mehr-abad district, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1385666161
Phone
+98 21 6662 4672
Email
mr-khanmohammadi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khanmohammadi
Position
Graduated, not a faculty member
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Mohammad Reza Khanmohammadi, No 33, Mirghaderi alley, Gozalkhoue Street, south Mehr-abad district, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1385666161
Phone
+98 21 6662 4672
Email
mr-khanmohammadi@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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 a portion of the data such as main outcomes information would be shared.
When the data will become available and for how long
Start of access period from March 2020.
To whom data/document is available
Scholars working in academic and scientific institutes that have scientific merit.
Under which criteria data/document could be used
All statistical analysis on the data should be done under my authority.
From where data/document is obtainable
Mohammad Reza Khanmohammadi
Email:
m.reza_khanmohamadi@yahoo.com
What processes are involved for a request to access data/document
They should email Mr. Khanmohammadi. After evaluating their scientific competency, the data will send to them during less than a week.