Low Back PainNCT01217554
Kinematical Evaluation of Lumbar Rotation in Chronic Low Back Pain
An observational study of Low Back Pain, run by Clalit Health Services at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Individuals referred to physiotherapy for LBP
Who may be able to join
- non specific chronic LBP (three months or more)
- Insured by Clalit Health Care Services
- Signed informed consent
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Disability, Kinematic measures
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: one evaluation at enrollement
Disability Questionnaire
Roland Morris Disability Questionnaire
Measured: one evaluation at enrollement
pain assessment
Visual analog scale for pain assessment
Measured: one evaluation at enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzi Milman, Clalit Health Services
- Investigators
- Noga Maor Rougin, MD, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAELALAA HAJ, BA, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAELUzi Milman, MD, Study director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217554
- Sponsor's protocol ID
- K09158ctil
- Status last verified
- Feb 2012
- First submitted
- 6 Oct 2010
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01217554
- Acronym / sponsor ID
- K09158ctil
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Disability, Kinematic measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals referred to physiotherapy for LBP
Key inclusion criteria (3 listed)
- non specific chronic LBP (three months or more)
- Insured by Clalit Health Care Services
- Signed informed consent
Key exclusion criteria (6 listed)
- History of spinal /pelvic surgery.
- Trauma or fracture of spine /pelvis.
- Inflammatory diseases of spine.
- radiation to lower extremities .
- Neurological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinematic measures of rotation movement of the lumbar spine
Time frame: one evaluation at enrollement
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
Roland Morris Disability Questionnaire
pain assessment
Time frame: one evaluation at enrollement
Visual analog scale for pain assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noga Maor Rougin, MD principal investigator
Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
ALAA HAJ, BA principal investigator
Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
Uzi Milman, MD study director
Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Clalit Health Services at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic measures of rotation movement of the lumbar spine (time frame: one evaluation at enrollement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.