Spine Biomechanics during Functional Activities in Patients with Chronic Low Back Pain: A Pilot Feasibility Study
Organizational Data
- DRKS-ID:
- DRKS00012538
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-07-17
- Last update in DRKS:
- 2020-08-13
- Registration type:
- Prospective
Acronym/abbreviation of the study
SpineBiomechLBP
URL of the study
No Entry
Brief summary in lay language
One in five persons between the ages of 20 and 59 years suffers from chronic low back pain. In 90% of all cases, the cause of pain is unknown and the treatment success thus relatively low. A profound knowledge of the underlying mechanisms that lead to chronic low back pain would allow to optimize treatment methods and preventive strategies in order to improve pain management. Therefore, we would like to biomechanically analyze the spine of 20 patients with chronic low back pain during everyday functional activities and to compare the data with those of healthy controls. The study-specific examinations will take place in the movement laboratory of the Bern University of Applied Sciences and include the following: • Clinical measurement of joint range of motion as well as muscle strength. • Assessment of pain intensity and level of disability using questionnaires (only in patients) • Biomechanical measurements of the spine during functional activities (sitting, standing, standing up from a chair, vertical jumps, forward/backward leaning and walking) using non-invasive motion analysis systems.
Brief summary in scientific language
Given the weak effects of current treatment methods for non-specific CLBP, a deeper insight into the underlying mechanisms from a biomechanical point of view appears to be of high importance. Most available biomechanical studies investigating the spine of CLBP-patients during dynamic functional activities used simple kinematic or surface electromyography parameters (Christe et al. 2016, Gombatto et al. 2015, Dubois et al. 2014), allowing only very limited conclusions on possible underlying mechanisms. One reason for the choice of these relatively simple parameters could be that the reliable assessment of the spine during functional activities using more complex biomechanical parameters is challenging and understudied throughout the scientific literature. However, recent advancements in the fields of marker-based motion capturing and musculoskeletal modelling provide the required tools to study biomechanical parameters of the spine such as curvature and inter-segmental angles as well as compressive, shear and individual muscle forces (Ignasiak et al. 2016a&2016b, Schmid et al. 2016a&2016b). Primary objective: To evaluate sagittal plane kinematics as well as segmental loading and muscle forces of the spine during daily activities (i.e. standing, sitting, chair rising, vertical jumping, bending forward/backward and walking) in patients with CLBP in comparison with data of healthy controls. Secondary objectives: - To compare a portable assessment tool for measuring sagittal plane spinal kinematics (Epionics SPINE system) with the standard camera based method (VICON motion capture system) and to evaluate its inter- and intra-session reliability. - To compare a portable assessment tool for measuring lower extremity kinematics (myon aktos-t) with the standard camera based method (VICON motion capture system) and to evaluate its inter- and intra-session reliability. - To investigate the relationship between sagittal plane spinal kinematics and clinical outcome measures such as level of disability (Oswestry Disability Index, ODI) and pain (Visual Analogue Scale, VAS) as well as joint range of motion and muscle strength.
Health condition or problem studied
- ICD10:
- M54.5 - Low back pain
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
Endpoints
- Primary outcome:
- 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:
- - 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.
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Fachhochschule / University of Applied Sciences Bern
Recruitment period and number of participants
- Planned study start date:
- 2018-05-05
- Actual study start date:
- 2018-05-05
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-05-31
- Target Sample Size:
- 40
- Final Sample Size:
- 35
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 60 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Bern University of Applied Sciences, Health DivisionPD Dr. phil. Heiner BaurMurtenstrasse 103008 BernSwitzerland
- Telephone:
- +41 31 848 45 15
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Bern University of Applied Sciences, Health DivisionDr. sc. Stefan SchmidMurtenstrasse 103008 BernSwitzerland
- Telephone:
- +41 31 848 37 96
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Bern University of Applied Sciences, Health DivisionDr. sc. Stefan SchmidMurtenstrasse 103008 BernSwitzerland
- Telephone:
- +41 31 848 37 96
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Bern University of Applied Sciences, Health DivisionMurtenstrasse 103008 BernSwitzerland
- Telephone:
- +41 31 848 37 96
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Kantonale Ethikkommission (KEK) BernMurtenstrasse 313010 BernSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.be.ch/kek
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-05-09
- Ethics committee number:
- 2017-00820
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-06-19
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Suter M, Eichelberger P, Frangi J, Simonet E, Baur H, Schmid S. Measuring lumbar back motion during functional activities using a portable strain gauge sensor-based system: a comparative evaluation and reliability study. Journal of Biomechanics. 2020;100:109593.
- Simonet E, Winteler B, Frangi J, Suter M, Meier ML, Eichelberger P, Baur H, Schmid S. Walking and running with non-specific chronic low back pain: what about the lumbar lordosis angle? Journal of Biomechanics. 2020;108:109883.
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry