The effect of 16 sessions core stabilization exercises on spine kinematics during walking both with and without load in patients with non-specific chronic low back pain and comparison with healthy control group
The aim of this study is to evaluate the effect of spinal stabilization exercises on the spine kinematics during walking. Patients with a history of at least 3 months Non-specific chronic Low Back Pain (NCLBP) in the range of 18-45 years are enrolled after filling out a consent form. Each patient without exclusion criteria (rheumatologic and neurologic disease, past history of surgery or any condition that is contraindicated for the exercise therapy) will complete the perceived pain questionnaire and the Oswestry Disability Questionnaire. Then in the first session, the spine kinematics will be evaluated in the motion analysis laboratory. Markers are placed on the trunk (acromion process and T12 ), lumbar (T12, L3 and S2), pelvis (bilateral ASIS and PSIS) and foot (bilateral posterior heel center and fifth MTP) and the patient is asked to walk with self-selected daily speed in a direction of 10 meters at a rate of 3 times without load and 3 times with a load approximately 10% of their body weight. Then, each patient participate in the 16 sessions of patient-specific spinal stabilization exercise training that will be given three times a week for 6 weeks. In the final session, pain, disability and spinal column kinematic will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080829264N1
Registration date:2016-08-28, 1395/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Rasool Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 1022
Email address
rasool.bagheri@ymail.com
Recruitment status
Recruitment complete
Funding source
IRAN University of Medical Sciences
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 16 sessions core stabilization exercises on spine kinematics during walking both with and without load in patients with non-specific chronic low back pain and comparison with healthy control group
Public title
The effects of spinal specific exercise therapy for treatment of chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
Low back pain from lower thorasic rib to the upper gluteal fold lasted more than 12 weeks.
The range of pain would between 3-6 according to the VAS
Exclusion:
Any medical condition who have contraindications to exercise therapy.
Acute low back pain or back pain that occurred in less than 12 weeks.
BMI above 25 kg/m2.
Sciatic nerve root involvement.
Pain radiating to the leg below the knee.
Feeling paresthesia in the legs.
Motor deficits in the lower limb muscles (MMT, grade 3.5 and less on the basis of Kendall approach).
Acute spinal disc herniation (MRI reports or medical reports).
History of surgery and lumbar spine fractures or other spinal structures (self-reported).
Malignancy(self-reported).
Pregnancy(self-reported).
Radicular symptoms during daily activities, especially walking (self-reported).
During the intervention, the patient will be banned from any sports activities.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IRAN University of Medical Science
Street address
"Next to the Milad Hospital" "Hemmat Highway"
City
Tehran
Postal code
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.IUMS.REC 1395.9211342205
Health conditions studied
1
Description of health condition studied
chrionic low back pain
ICD-10 code
M54.5
ICD-10 code description
Loin pain, Low back strain
Primary outcomes
1
Description
spinal kinematic
Timepoint
before and after treatment
Method of measurement
motion analysis system of qualysis
2
Description
disability
Timepoint
before and after treatment
Method of measurement
ODI disability quasionnare
3
Description
pain
Timepoint
before and after treatment
Method of measurement
100 mm VAS scale
Secondary outcomes
1
Description
pain due to the core stabilization exercise
Timepoint
during assessment and treatment
Method of measurement
self reported
Intervention groups
1
Description
specific spinal stabilization exercise that lasted in 16 sessions and 6 weeks and 3 times in each week. each session lasted for 45 minutes.
Category
Rehabilitation
2
Description
In control healthy subjects, There will be no intervention.