The aim of this double blind randomize clinical trial study is to investigate the effects of 10%uphill treadmill walking in comparison to level treadmill walking in chronic nonspecific low back pain.men and women with chronic nonspecific low back pain include into study.patients with BMI more than 30,previous history ofspinal column instability or fracture,heart disease,sever lower limb degenerative changes or arthroplasty ,scoliosios,patients with knee pain and pregnant women exclude from the study.twelve patients randomize into two groups:intervention and control.patients in both groups treat three sessions every week for four weeks.at first in every session all patient treat with standard physiotherapy include electrotherapy and mobilisation techniques.then they walk on treadmill 20 minutes at first week.every week 5 minutes add to this treadmill walking time.control group walks on level treadmill but intervention groups wallk on 10%uphill treadmill.back muscle endurance is primary variable.fear avoidance belief,vas and oswestry disability index are secondary variables.these outcome measures estimate three times.first time is before the study,second time is after study at fourth week.third time is two month later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090321479N3
Registration date:2016-09-12, 1395/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Abdolkarim Karimi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2024
Email address
a_karimi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Esfahan University of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pilot study:the effects of 10%uphill treadmille walking in comparison to level treadmill walking in patients with nonspescific chronic low back pain.
Public title
The effects of treadmill walking in low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:men and women,chronic nonspescific low back pain.
Exclusion criteria:previous history spinal canal surgery; BMI>30; previous history of back fracture or instability; previous history of chronic heart failure or coronary disease; fracture or sever degenerative changes in lower limb joints; lower limb arthroplasty; pregnant women; knee pain; scoliosis.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Esfahan University of Medical Sciences
Street address
Hezar Greeb Street
City
Esfahan
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
ir.mui.rec.1394.3.567
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
m54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
Back endurance test
Timepoint
Before 1th session,12th session,two m1.before the study at first session,2.fourth week(.12th session),3.two month after the final sessioonth afther the final session
Method of measurement
Modified sorenson test
Secondary outcomes
1
Description
Disability
Timepoint
1.before the study at first session,2.fourth week(.12th session),3.two month after the final session
Method of measurement
Questionnaire
2
Description
Fear avoidance belief
Timepoint
1.before the study at first session,2.fourth week(.12th session),3.two month after the final session
Method of measurement
Questionnaire
3
Description
Vas
Timepoint
1.before the study at first session,2.fourth week(.12th session),3.two month after the final session
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention:four weeks intervention,three sessions every week.include:electrotherapy,mobilisation and treadmill walking on 10%uphill inclination.
Category
Rehabilitation
2
Description
Control group :four weeks intervention,three sessions every week.include:electrotherapy,mobilisation and treadmill walking on level surface.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Central Physiotherapy clinic
Full name of responsible person
Reza Soleimanpoor
Street address
Esfahan,Falavarjan,Pirbakran,Motahary street
City
Pirbakran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Zahrasadat Rezaeian
Street address
Hezar Greeb street
City
Esfahan
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
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Abdolkarim Karimi
Position
PHD.PHYSIOTHERAPY
Other areas of specialty/work
Street address
Esfahan University of Medical Sciences.Rehabilitation school
City
Esfahan
Postal code
Phone
+98 31 3668 1853
Fax
Email
a_karimi@rehab.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Abdolkarim Karimi
Position
PHD.Physiotherapy
Other areas of specialty/work
Street address
Esfahan Medical University.Rehabilitation school
City
Esfahan
Postal code
iran
Phone
+98 31 3668 1853
Fax
Email
a_karimi@rehab.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Abdolkarim Karimi
Position
PHD.physiotherapy
Other areas of specialty/work
Street address
Esfahan University of Medical Sciences,Rehabilitation School
City
Esfahan
Postal code
Phone
+98 31 3668 1853
Fax
Email
a_karimi@rehab.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)