Comparison of the effects of lumbar manipulation on pain, disability and selective biomechanical parameters in athletes with low back pain based on Delitto classification subgroup of manipulation and other subgroups
Comparison of the effect of manipulation on pain, functional disability and some biomechanical parameters in athletes with low back pain based on Delitto classification subgroup of manipulation and other subgroups
Design
Clinical trial, community base, double-blind, follow up after one month
Group1: 23 athletes with low back pain, haveing criteria described by manipulation subgroup of Delitto classification system
Group2: 23 athletes with low back pain, have no criteria described by manipulation subgroup of Delitto classification system
Settings and conduct
People with low back pain enter the study after preliminary assessment; The study will be conducted in the Faculty of Rehabilitation sciences, Shiraz University of Medical Sciences; Patient and assessor are both unaware of the grouping; Manipulation will be applied in three sessions; The outcome measures will be evaluated before and after treatment
Participants/Inclusion and exclusion criteria
Inclusion:
Age range 18 to 35 years (both groups)
Practice athletic training at least 3 times a week for 2 hours each time (both groups)
Haveing 4 of 5 criteria described by manipulation subgroup of Delitto classification system (Delitto group)
People who have low back pain but have not the criteria described by Delitto classification system (non-Delitto group)
No contrandication for lumbar manipulation (non-Delitto group)
Exclusion:
Physiotherapy and manual therapy over the past 3 months
Taking analgesic and inflammatory drugs within past 48 hours
Surgical history in lumbar and pelvis
Spinal abnormalities
Corticosteroids injection within the past 1 month
Pressure on the lumbar nerve roots
Diabetes, rheumatoid arthritis, neuropathy
Intervention groups
Manipulation will be applied in both low back pain groups
Comparison of the effects of lumbar manipulation on pain, disability and selective biomechanical parameters in athletes with low back pain based on Delitto classification subgroup of manipulation and other subgroups
Public title
The effect of manipulation on athletes with low back pain in Delitto and non-Delitto gorups
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 35 years (for both groups)
People who practice athletic training at least three times a week for two hours each time (for both groups)
Haveing 4 of 5 criteria described by manipulation subgroup of Delitto classification system (for Delitto group)
People who have low back pain but have not the criteria described by manipulation subgroup of Delitto classification system (for non-Delitto group)
People who have no contrandication for lumbar manipulation (for non-Delitto group)
Exclusion criteria:
Physiotherapy and manual therapy over the past 3 months
Taking analgesic and inflammatory drugs within past 48 hours
Pressure on the lumbar nerve roots
Surgical history in lumbar and pelvis
Spinal abnormalities
Corticosteroids injection within the past 1 month
Diabetes, rheumatoid arthritis, neuropathy
History of neurological disorders or central nervous system disease
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient will be unaware of the group that located in
The researcher who will do the assessments will be unaware of the groups
Placebo
Not used
Assignment
Other
Other design features
The low back pain patients who have 4 of 5 criteria described by manipulation subgroup of Delitto classification system will be allocated to the Delitto group and the low back pain patients who have not these criteria will be allocated to the non-Delitto group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
7th floor, Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
71345-1733
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.SUMS.REC.1397.517
Health conditions studied
1
Description of health condition studied
Low back pain based on the criteria of manipulation subgroup of Delitto and Low back pain based on the non-Delitto criteria
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before, after and one month after treatment
Method of measurement
Numeric rating scale
2
Description
Functional disability
Timepoint
Before and one month after treatment
Method of measurement
Functional disability level questionnaire
Secondary outcomes
1
Description
Lumbar lordosis
Timepoint
Before and after treatment
Method of measurement
Flexible ruler
2
Description
Joint proprioception
Timepoint
Before and after treatment
Method of measurement
Inclinometer
3
Description
Balance
Timepoint
Before and after treatment
Method of measurement
"Single leg stance" test and "timed up and go" test
Intervention groups
1
Description
Group 1: 23 athleths with low back pain who have 4 of 5 criteria of Delitto manipulation subgroup. The interventions will be the "lumbar manipulation". The manipulation will be applied on the patient in the side-lying position during 3 sessions.
Category
Rehabilitation
2
Description
Group 2: 23 athleths with low back pain who have not the criteria of Delitto manipulation subgroup. The interventions will be the "lumbar manipulation". The manipulation will be applied on the patient in the side-lying position during 3 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz medical clinics
Full name of responsible person
Amirhossein Akbarpur
Street address
School of Rehabilitation Sciences, 1st Abiverdi, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
amirhosseinakbarpur@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
7th floor, Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Amirhossein Akbarpur
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, 1st Abiverdi, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
amirhosseinakbarpur@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amirhossein Akbarpur
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, 1st Abiverdi, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
amirhosseinakbarpur@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amirhossein Akbarpur
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, 1st Abiverdi, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
amirhosseinakbarpur@yahoo.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results will be published as an article in the research international journals
When the data will become available and for how long
In the next one to two years
To whom data/document is available
Only people who ask the information from the main investigator
Under which criteria data/document could be used
With the permission through a written or an oral request
From where data/document is obtainable
School of Rehabilitation Sciences, Shiraz University of Medical Sciences, 1st Abiverdi, Chamran Blv., Mr Amirhossein Akbarpur, Phone number: 0098 71 36271551
What processes are involved for a request to access data/document
With a written request, they can access the library of Shiraz University of Medical Sciences, School of Rehabilitation Sciences