Low Back PainNCT00754585
The Effectiveness of the Logic Back™Support.
An observational study of Low Back Pain and Posture, run by Canadian Memorial Chiropractic College at 2 sites in Canada.
Trial summary
Back pain and chair use are the second most important health factors for the aging workforce. Besides personal suffering, postural discomfort in the workplace reduces performance and productivity, both of which can be improved by raising comfort levels. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Posture
- What is being tested?
- Logic Back Grahl Duo Back Model DB11-01
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2008to Oct 2009
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Males only, ages between 20-55 years of age
Who may be able to join
- Male
- Between ages of 20-55
- With or without lower back pain
Who cannot join
- Participants currently experiencing neck, shoulder or arm pain
- Participants who have low back pain of non-musculoskeletal origin
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8S 4L8
Canadian Memorial Chiropractic College
North York, Ontario, M2H 3J1
About this study
Official title: The Effectiveness of the Logic Back™Support in Promoting a Comfortable Neutral Low Back Position, Reduced Muscular Effort, Improved Performance, and Decreased Postural Shifts in Seating.
Back pain and chair use are the second most important health factors for the aging workforce. Besides personal suffering, postural discomfort in the workplace reduces performance and productivity, both of which can be improved by raising comfort levels. In an attempt to improve comfort and reduce injury risk, ergonomic chairs are commonly equipped with lumbar supports in an attempt to support a "neutral" spine. However, people often alter their position when such a device is in place as they arch their back to conform to it. The Logic Back support offers a simple means to alter posture and reduce associated strain on the lower back during seated tasks by supporting the "Effortless Neutral Position" or the natural curvature of the low back. Although it has been used clinically by many practitioners, its effectiveness has yet to be shown by scientific study. The current work will help to understand if and why the Logic Back is effective and how it can become a low-cost solution to reduce the discomfort of those suffering from low back pain.
The purpose of this study is to determine the effectiveness of the Logic Back and the "Effortless Neutral Position" in improving comfort and functional performance during seated tasks, as compared to a standard, ergonomic chair.
Read the detailed description
Seventeen of the top Canadian occupations typically have workers sitting a significant proportion of their work day. An average of 30% of Ontario WSIB lost time claims since 1996 involve low back injury. The return to work objective for twenty percent of these patients requires prolonged sitting in their work stations. While a number of these studies have claimed a relationship between sitting and LBP, the relationship is complex. Back pain and chair use are the second most important health factors for the aging workforce. The odds ratio for LBP is estimated for seated tasks at 1.9721. Prolonged and monotonous, low-level mechanical loads associated with a seated posture are thought to provoke pain.
Besides personal suffering, postural discomfort in the workplace reduces performance and productivity, both of which can be improved by raising comfort levels. According to Corlett (2006), other lumbar supports do not exert enough pressure on the spine to actually change its configuration. However, the patient often alters their posture when such a device is in place as they arch their back to conform to it. The Logic Back support offers a simple means to alter posture and reduce associated strain on the lower back during seated tasks by promoting the neutral standing lordotic posture. Clinically, it has been shown to support the ENP or the natural standing lordotic posture. Although its clinical applicability has been accepted by many practitioners, its effectiveness in improving seated comfort and functional task performance has yet to be quantified in LBP patients who perform seated tasks. This study will help to understand why the Logic Back or ENP must be considered when planning return-to-work goals and methods to reduce first-time injury incidence in the workplace.
- Conditions
- Low Back Pain, Posture
- Being tested
- Logic Back Grahl Duo Back Model DB11-01
- 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.
Logic Back Grahl Duo Back Model DB11-01Device
The device is placed against the back rest of a chair. The tension of the straps are adjusted for each participant to obtain the ENP.
| Study group | Role | What they receive |
|---|---|---|
| I | All participants will perform the five Chair Support tasks: (1) quiet standing, sitting, (2) upper back unsupported, (3) sitting, upper back unsupported with Logic Back in place, (4) sitting in a standard ergonomic chair, and (5) sitting in a standard ergonomic chair with Logic Back in place. Aside from the Quiet Standing trials which will be performed first, the order of Chair Support will be randomized. Participants will perform the Chair Support task for 30 minutes while quietly watching a movie DVD of their choice. The DVDs provided will the "light" in content without a lot of suspense or emotion. Data will be collected for the final two minutes of each 30-minute trial. Receives: Device: Logic Back Grahl Duo Back Model DB11-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated CoP Shift Rate: The CoP wil be measured by use of a TEKSCAN CONFORMat system - a thin sensing mat that is placed on the chair surface and measures the relative pressure applied by the legs and buttocks during seated tasks.
Measured: 30 minutes
Functional Performance (Task Repetition Frequency)- three dynamic, seated performance tests are used and include: Test 1 - "Waist level-Up", Test 2 - "Eye level-down", and Test 3 - "Overhead work".
Measured: 5 minutes
Secondary outcomes (4)
Self-Reports of Comfort: Tests such as the Visual Analog Scale (VAS) or mapping by body area will be used. Participants will also be asked to record their current level of discomfort on a 10cm VAS for each body area.
Measured: 5 minutes
Postural Quantification: Electromagnetic sensors (Polhemus 3-space Isotrak system) will allow for the continuous and automatic monitoring of key body landmark positions and orientations in space.
Measured: 2 minutes
RMS-EMG (Muscular Exertion): Following standard skin preparation (shaving as needed, alcohol cleansing and mild abrasion) surface electrodes (10 mm Ag-AgCL, 1 cm interspace) will be applied and oriented parallel to the target muscles.
Measured: 2 minutes
Evaluation of Spinal Loads: Load on the spine is a combined effect of the posture, muscle activity and task being performed. The UM3D model is a validated lift task analysis system.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Logic Back, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754585
- Sponsor's protocol ID
- 082007
- Status last verified
- Nov 2010
- First submitted
- 4 Sep 2008
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Grondin DE, Triano JJ, Tran S, Soave D. The effect of a lumbar support pillow on lumbar posture and comfort during a prolonged seated task. Chiropr Man Therap. 2013 Jul 4;21(1):21. doi: 10.1186/2045-709X-21-21.
PubMed 23826832
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Logic Back™Support in Promoting a Comfortable Neutral Low Back Position, Reduced Muscular Effort, Improved Performance, and Decreased Postural Shifts in Seating.
- ClinicalTrials.gov ID
- NCT00754585
- Acronym / sponsor ID
- 082007
- Conditions
- Low Back Pain, Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Logic Back, McMaster University
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Sep 2008 (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.
Back pain and chair use are the second most important health factors for the aging workforce. Besides personal suffering, postural discomfort in the workplace reduces performance and productivity, both of which can be improved by raising comfort levels. In an attempt to improve comfort and reduce injury risk, ergonomic chairs are commonly equipped with lumbar supports in an attempt to support a "neutral" spine. However, people often alter their position when such a device is in place as they arch their back to conform to it. The Logic Back support offers a simple means to alter posture and reduce associated strain on the lower back during seated tasks by supporting the "Effortless Neutral Position" or the natural curvature of the low back. Although it has been used clinically by many practitioners, its effectiveness has yet to be shown by scientific study. The current work will help to understand if and why the Logic Back is effective and how it can become a low-cost solution to reduce the discomfort of those suffering from low back pain.
The purpose of this study is to determine the effectiveness of the Logic Back and the "Effortless Neutral Position" in improving comfort and functional performance during seated tasks, as compared to a standard, ergonomic chair.
Detailed description
Seventeen of the top Canadian occupations typically have workers sitting a significant proportion of their work day. An average of 30% of Ontario WSIB lost time claims since 1996 involve low back injury. The return to work objective for twenty percent of these patients requires prolonged sitting in their work stations. While a number of these studies have claimed a relationship between sitting and LBP, the relationship is complex. Back pain and chair use are the second most important health factors for the aging workforce. The odds ratio for LBP is estimated for seated tasks at 1.9721. Prolonged and monotonous, low-level mechanical loads associated with a seated posture are thought to provoke pain.
Besides personal suffering, postural discomfort in the workplace reduces performance and productivity, both of which can be improved by raising comfort levels. According to Corlett (2006), other lumbar supports do not exert enough pressure on the spine to actually change its configuration. However, the patient often alters their posture when such a device is in place as they arch their back to conform to it. The Logic Back support offers a simple means to alter posture and reduce associated strain on the lower back during seated tasks by promoting the neutral standing lordotic posture. Clinically, it has been shown to support the ENP or the natural standing lordotic posture. Although its clinical applicability has been accepted by many practitioners, its effectiveness in improving seated comfort and functional task performance has yet to be quantified in LBP patients who perform seated tasks. This study will help to understand why the Logic Back or ENP must be considered when planning return-to-work goals and methods to reduce first-time injury incidence in the workplace.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | Device: Logic Back Grahl Duo Back Model DB11-01All participants will perform the five Chair Support tasks: (1) quiet standing, sitting, (2) upper back unsupported, (3) sitting, upper back unsupported with Logic Back in place, (4) sitting in a standard ergonomic chair, and (5) sitting in a standard ergonomic chair with Logic Back in place. Aside from the Quiet Standing trials which will be performed first, the order of Chair Support will be randomized. Participants will perform the Chair Support task for 30 minutes while quietly watching a movie DVD of their choice. The DVDs provided will the "light" in content without a lot of suspense or emotion. Data will be collected for the final two minutes of each 30-minute trial. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males only, ages between 20-55 years of age
Key inclusion criteria (3 listed)
- Male
- Between ages of 20-55
- With or without lower back pain
Key exclusion criteria (2 listed)
- Participants currently experiencing neck, shoulder or arm pain
- Participants who have low back pain of non-musculoskeletal origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Logic Back Grahl Duo Back Model DB11-01The device is placed against the back rest of a chair. The tension of the straps are adjusted for each participant to obtain the ENP. | Device | I |
Primary outcome
Seated CoP Shift Rate: The CoP wil be measured by use of a TEKSCAN CONFORMat system - a thin sensing mat that is placed on the chair surface and measures the relative pressure applied by the legs and buttocks during seated tasks.
Time frame: 30 minutes
Functional Performance (Task Repetition Frequency)- three dynamic, seated performance tests are used and include: Test 1 - "Waist level-Up", Test 2 - "Eye level-down", and Test 3 - "Overhead work".
Time frame: 5 minutes
4 secondary outcomes
Self-Reports of Comfort: Tests such as the Visual Analog Scale (VAS) or mapping by body area will be used. Participants will also be asked to record their current level of discomfort on a 10cm VAS for each body area.
Time frame: 5 minutes
Postural Quantification: Electromagnetic sensors (Polhemus 3-space Isotrak system) will allow for the continuous and automatic monitoring of key body landmark positions and orientations in space.
Time frame: 2 minutes
RMS-EMG (Muscular Exertion): Following standard skin preparation (shaving as needed, alcohol cleansing and mild abrasion) surface electrodes (10 mm Ag-AgCL, 1 cm interspace) will be applied and oriented parallel to the target muscles.
Time frame: 2 minutes
Evaluation of Spinal Loads: Load on the spine is a combined effect of the posture, muscle activity and task being performed. The UM3D model is a validated lift task analysis system.
Time frame: 2 minutes
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 17 Nov 2010.
- Derived from this study: PubMed 23826832Grondin DE, Triano JJ, Tran S, Soave D. The effect of a lumbar support pillow on lumbar posture and comfort during a prolonged seated task. Chiropr Man Therap. 2013 Jul 4;21(1):21. doi: 10.1186/2045-709X-21-21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 and Posture, run by Canadian Memorial Chiropractic College at 2 sites in Canada.
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 2 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 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Seated CoP Shift Rate: The CoP wil be measured by use of a TEKSCAN CONFORMat system - a thin sensing mat that is placed on the chair surface and measures the relative pressure applied by the legs and buttocks during seated tasks. (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754585, which also lists 1 linked publication.
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 17 Nov 2010.