The effect of a prototype feedback and passive spinal support device on spinal loading during load handling tasks in healthy subjects and low back pain patients.
- Conditions
- low back pain10023213
- Registration Number
- NL-OMON47119
- Lead Sponsor
- Vrije Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Healthy Worker
- No previous history of LBP in the last 12 months
- Owestry Disability Index <20 indicating minimal disability
- Working in an occupational field that requires manual material handling ;Patients
- Lumbar or lumbosacral pain without proximal radicular pain (limited distally to the knees)
- Presence of recurrent low back pain
- Owestry Disability Index >20 and <50 to make sure that patients have sufficiently severe CLBP but are still able to perform hand loading tasks
- Working or have been working in an occupational field that requires manual material handling
Healthy worker
* - Motor deficits and sensorimotor deficits (lower limb immobility, posture, gait, upper limbs)
* - Specific radiographic abnormalities (severe disc space narrowing, spondylolysis, spondylolisthesis, scoliosis, etc.).
* - Previous back surgery
* - Thoracic or cervical pain
* - Pain in the hip region
* - Neurological disorders
* - LBP in the last 2 years that did require them to seek medical attention or to change their activities;Workers with recurrent low back pain
* - Motor deficits and sensorimotor deficits (lower limb immobility, posture, gait, upper limbs)
* - Specific radiographic abnormalities (severe disc space narrowing, spondylolysis, spondylolisthesis, scoliosis, etc.).
* - Previous back surgery
* - Thoracic or cervical pain
* - Pain in the hip region
* - Neurological disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In part I and II, our main goal is to investigate if our assistive device is<br /><br>effective in reducing mechanical back loads, defined in terms of:<br /><br><br /><br>* Peak and cumulative L5S1 compression force<br /><br>* Lumbar angular accelerations (uncontrolled spine motion)<br /><br>* Lumbar angles (spine flexion and asymmetrical spine motion)<br /><br>* Co-contraction<br /><br><br /><br>In part III our main goal is to analyze the feasibility and satisfaction to use<br /><br>the assistive device in the working environment, defined in terms of:<br /><br><br /><br>* System Usability Scale (SUS) score of each participant<br /><br>* Patient*s Global Impression of Change (PGIC) score<br /><br>* Clinicians Global Impression of Change (CGIC) score<br /><br>* Individual classification code based on the ICF- framework</p><br>
- Secondary Outcome Measures
Name Time Method <p>In parts I and II, our secondary goals are to investigate the effect of our<br /><br>assistive device on the work performance in terms of:<br /><br><br /><br>* Effort<br /><br>- Heart rate<br /><br>- Perceived effort<br /><br>* Productivity<br /><br>- Time to complete the task cycle<br /><br>* Discomfort<br /><br>- Local Perceived Discomfort Scale<br /><br><br /><br>and to investigate the effect on performance of daily activities in terms of:<br /><br><br /><br>* Self-Paced Walk Test (SPWT)<br /><br>- Walking speed<br /><br>* Stair Climb Test (SCT)<br /><br>- Time<br /><br>* Six-Minute Walk Test (6MWT)<br /><br>- Distance<br /><br>* Chair Stand Test (CST)<br /><br>- Time<br /><br>* Timed Up and Go (TUG)<br /><br>- Time<br /><br>In part III, our secondary goal is to analyze the effect on fear of movement in<br /><br>terms of:<br /><br><br /><br>* Score of Tampa Scale Kinesiophobia (TSK) </p><br>