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Kinematical Evaluation of Lumbar Rotation in Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01217554
First received: October 6, 2010
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Kinematical Evaluation of Lumbar Rotation in Neutral Position and Full Flexion in Sitting and Standing in Patients With Non-specific Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Kinematic measures of rotation movement of the lumbar spine [ Time Frame: one evaluation at enrollement ] [ Designated as safety issue: No ]
    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) .

  • Disability Questionnaire [ Time Frame: one evaluation at enrollement ] [ Designated as safety issue: No ]
    Roland Morris Disability Questionnaire

  • pain assessment [ Time Frame: one evaluation at enrollement ] [ Designated as safety issue: No ]
    Visual analog scale for pain assessment


Enrollment: 50
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
age-matched healthy male participants
age-matched healthy male participants without LBP
participants with non specific chronic LBP
male participants with non specific chronic LBP

Detailed 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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Individuals referred to physiotherapy for LBP

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217554

Locations
Israel
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
Sponsors and Collaborators
Clalit Health Services
Investigators
Principal Investigator: Noga Maor Rougin, MD Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
Principal Investigator: ALAA HAJ, BA Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
Study Director: Uzi Milman, MD Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
  More Information

No publications provided

Responsible Party: Uzi Milman, Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL., Clalit Health Services
ClinicalTrials.gov Identifier: NCT01217554     History of Changes
Other Study ID Numbers: K09158ctil
Study First Received: October 6, 2010
Last Updated: February 8, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Low Back Pain
Disability
Kinematic measures

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013