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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 13 January 2020
Main ID:  DRKS00012538
Date of registration: 17/07/2017
Prospective Registration: Yes
Primary sponsor: Bern University of Applied Sciences, Health Division
Public title: Spine Biomechanics during Functional Activities in Patients with Chronic Low Back Pain: A Pilot Feasibility Study
Scientific title: Spine Biomechanics during Functional Activities in Patients with Chronic Low Back Pain: A Pilot Feasibility Study - SpineBiomechLBP
Date of first enrolment: 05/05/2018
Target sample size: 40
Recruitment status: Complete: follow-up complete
URL:  http://www.drks.de/DRKS00012538
Study type:  observational
Study design:  Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Other. Assignment: Other. Study design purpose: Basic research/physiological study;  
Phase:  N/A
Countries of recruitment
Switzerland
Contacts
Name: Stefan    Schmid
Address:  Murtenstrasse 10 3008 Bern Switzerland
Telephone: +41 31 848 37 96
Email: stefan.schmid(at)bfh.ch
Affiliation:  Bern University of Applied Sciences, Health Division
Name: Stefan    Schmid
Address:  Murtenstrasse 10 3008 Bern Switzerland
Telephone: +41 31 848 37 96
Email: stefan.schmid(at)bfh.ch
Affiliation:  Bern University of Applied Sciences, Health Division
Key inclusion & exclusion criteria
Inclusion criteria: Patients:
- Chronic non-specific low back pain for at least 3 months
- Aged between 18 and 60 years

Healthy individuals:
- Healthy and free of pain
- Aged between 18 and 60 years

Exclusion criteria: General:
- Body mass index (BMI) > 30 kg/m2
- Specific spinal pathology or nerve root pain
- Neuromuscular disorders affecting gait and posture
- Injuries to the locomotor system which led to persistent deformities
- Inability to follow procedures due to psychological disorders
- Females: anamnestically known pregnancy


Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both, male and female
Health Condition(s) or Problem(s) studied
M54.5 - Low back pain
Intervention(s)
Intervention 1: Patients with chronic low back pain will be invited for the assessments in the movement laboratory. These include the completion of two questionnaires regarding pain and function, a standard clinical examination as well as the measurement of spinal and joint kinematics during daily activities such as standing, sitting, chair rising, vertical jumping, bending forward/backward and walking. For the latter, a marker-based optoelectronic motion analysis system (Vicon), a portable sensor-stripe based system (Epionics SPINE) and a portable IMU-based system (myon aktos-t) will be synchronously used. The laboratory visit will take approximately 150 minutes per patient and there will be no follow-up visits. Intervention 2: Healthy individuals will be recruited using a flyer in the university community and will be invited for the assessments in the movement laboratory. Except from the questionnaires, the assessments will be the same as for the patients. In addition to the initial visit, there will be an identical follow-up visit after 1 week. Each laboratory visit will take approximately 130-140 minutes per healthy individual.
Primary Outcome(s)
Spinal curvature angles as well as segmental loading and muscle forces assessed during daily activities using a VICON motion capture system and complex musculoskeletal simulations.

Primary outcome parameters will be assessed once in patients and twice (initial and follow-up visits) in healthy individuals.
Secondary Outcome(s)
- Spinal curvature angles assessed during daily activities in patients with CLBP as well as in healthy individuals using the Epionics SPINE system.
- Lower extremity kinematics assessed during daily activities in patients with CLBP and in healthy individuals using the myon aktos-t system as well as a VICON motion capture system.
- Clinical outcome measures: Level of disability (ODI), pain level (VAS) as well as maximum joint range of motion and strength of the major muscle groups

Secondary outcome parameters will be assessed once in patients and twice (initial and follow-up visits) in healthy individuals.
Secondary ID(s)
2017-00820
U1111-1197-2191
Source(s) of Monetary Support
Bern University of Applied Sciences, Health Division
Secondary Sponsor(s)
Ethics review
Status: approved
Approval date:
Contact:
Kantonale Ethikkommission (KEK) Bern
Murtenstrasse 31 3010 Bern Schweiz
Results
Results available:
Date Posted:
Date Completed: 31/05/2019
URL:
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