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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01217554
Other study ID # K09158ctil
Secondary ID
Status Completed
Phase N/A
First received October 6, 2010
Last updated February 8, 2012
Start date February 2011
Est. completion date February 2012

Study information

Verified date February 2012
Source Clalit Health Services
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Low back pain (LBP) is considered one of the most common musculoskeletal disorders in modern society, resulting in substantial costs to society. Factors associated with the development of low back pain include poor posture, strenuous work with the body, inadequate non ergonomic work and traumas.

Rotation movement pattern of the lumbar spine in different positions is essential aspect in understanding the LBP Pathophysiology. Rotation coupled with forward bending (flexion) is a dominant factor which could increase the risk LBP and disc prolapse. There is also a decline in range of motion (ROM) of rotation in forward bending (flexion) compared to neutral position during sitting and standing.

In addition,lumbar rotation movement patterns differ in population with LBP compared to asymptomatic individuals. Healthy individuals exhibit rotation accompanied by consistent coupled movement patterns of lateral bending in the opposite direction at thr upper levels, and by lateral bending in tge same direction at the lower levels . while Chronic LBP patients exhibit non consistent patterns altered from those of the normal population.


Description:

According to the investigators, Kinematic measures of velocity and acceleration of lumbar rotation in neutral position and full flexion in sitting and standing did not studied yet. Evaluating these parameters, in addition to ROM and plains evaluation in the LBP population, compared to healthy population will contribute a lot in understanding this issue.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria:

- non specific chronic LBP (three months or more)

- Insured by Clalit Health Care Services

- Signed informed consent

Exclusion Criteria:

- History of spinal /pelvic surgery.

- Trauma or fracture of spine /pelvis.

- Inflammatory diseases of spine.

- radiation to lower extremities .

- Neurological disease.

- malignancy disease. structural deformity of vertebral structures(scoliosis, kyphosis).

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Clalit Health Services, Haifa and Western Galilee District Haifa

Sponsors (1)

Lead Sponsor Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kinematic measures of rotation movement of the lumbar spine Kinematic measures of rotation movement of the lumbar spine (plain, range, angular velocity and acceleration) will be measured by using Lumbar motion monitor Industrial (ILMM) . one evaluation at enrollement No
Primary Disability Questionnaire Roland Morris Disability Questionnaire one evaluation at enrollement No
Primary pain assessment Visual analog scale for pain assessment one evaluation at enrollement No
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