NCT01217554

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

October 6, 2010

Last Update Submit

February 8, 2012

Conditions

Keywords

Low Back PainDisabilityKinematic measures

Outcome Measures

Primary Outcomes (3)

  • 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

  • Disability Questionnaire

    Roland Morris Disability Questionnaire

    one evaluation at enrollement

  • pain assessment

    Visual analog scale for pain assessment

    one evaluation at enrollement

Study Arms (2)

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

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals referred to physiotherapy for LBP

You may qualify if:

  • non specific chronic LBP (three months or more)
  • Insured by Clalit Health Care Services
  • Signed informed consent

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services, Haifa and Western Galilee District

Haifa, Israel

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Uzi Milman, MD

    Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL.

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 8, 2010

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations