- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03494452
Trunk Muscle Strength, Strength Endurance and Activity in Persons With Low Back Pain (TRUSC)
Study Overview
Detailed Description
Objectives
The current state of research in the field and of the investigators own clinical experience clearly shows that the role of trunk muscle function in LBP is poorly understood. Investigators will address the following research questions:
- Do persons with LBP have lower trunk muscle strength, lower trunk muscle strength endurance and lower trunk muscle activity than healthy controls?
- Are functional limitations because of LBP related to the level of muscle strength, strength endurance and activity?
To answer these questions, investigators will establish an experimental framework to study limitations in muscle function to address the following aims:
- To compare trunk muscle strength, strength endurance and activity between persons with LBP and healthy control persons.
- To determine the relationship between trunk muscle strength, strength endurance and activity, and the Oswestry Disability Index (ODI) score.
The experimental setting consists of a clinical assessment using a questionnaire and a biomechanical assessment comprising muscle strength tests, muscle strength endurance tests and electromyographic analysis. Electromyographic activity of selected trunk muscles will be recorded during isokinetic and isometric trunk flexion and extension strength tests and during isometric trunk flexion and extension strength endurance tests.
Hypotheses Investigators hypotheses are that i. persons with LBP have lower trunk muscle strength, strength endurance and activity than healthy controls subjects. ii. the intensity of the EMG signal in lower back muscles decreases faster during the strength endurance test in persons with LBP than in healthy control subjects. iii. clinical scores correlate with trunk muscle strength, strength endurance and activity.
Procedures First, written informed consent will be obtained before participants will undergo a clinical exam (inspection and palpation of the lower back, measurement of active range of motion) performed by a trained physical therapist (PS). All participants will complete questionnaires to obtain pain and functional scores and information on their typical physical activity level (approximate duration: 30 minutes). Bipolar skin electrodes will be placed on selected trunk muscles (approximate duration: 15 minutes) and participants will walk on a treadmill for 10 min (warm-up). Participants will be seated on a strength testing system and practice trunk flexion and extension movements for 1 min. Subsequently, subjects will be asked to perform isokinetic trunk flexion and extension tests at maximum effort. EMG signals of the trunk muscles will be recorded during the maximum isokinetic contractions (approximate duration: 20 minutes). Subsequently, subjects will lie supine on a bench with their legs and pelvis supported by the bench. Their upper legs will be secured to the bench using a 15 cm wide Velcro belt. Subjects will be asked to hold their trunk in a horizontal position as long as possible while EMG signals of the trunk muscles will be recorded (approximate duration: 5 minutes).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Basel Stadt
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Basel, Basel Stadt, Switzerland, 4031
- University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age ≥ 20 years
- age ≤ 55 years
- primarily seated occupational activities for at least 4 hours per working day
- patients:
- low back pain for at least 12 weeks
Exclusion Criteria:
- neurological symptoms
- diagnosed spinal damage
- cancer,or infectious diseases that could lead to chronic LBP
- other diseases that could affect physical performance
- surgery for chronic LBP
- pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Low back pain - no intervention
Patients who perform sitting occupational activities for at least 4 hours/day and have had low back pain for at least the previous 6 months
|
There is no intervention in this cross-sectional study
|
|
Healthy - no intervention
Healthy persons who perform sitting occupational activities for at least 4 hours/day
|
There is no intervention in this cross-sectional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Isokinetic trunk muscle flexion strength
Time Frame: 0 months
|
Maximum moment of isokinetic movement performed on a Biodex
|
0 months
|
|
Isokinetic trunk muscle extension strength
Time Frame: 0 months
|
Maximum moment of isokinetic movement performed on a Biodex
|
0 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk muscle activity
Time Frame: 0 months
|
The rate of change in frequency and intensity of the EMG signal during the strength endurance test for the Mm.
rectus abdominis, obliquus internus, obliquus externus, erector spinae longissimus, erector spinae iliocostalis, multifidus muscles
|
0 months
|
|
Isometric trunk muscle strength endurance
Time Frame: 0 months
|
Biering-Soerensen test completion time of the will be recorded when the upper part of the body descended below the horizontal line
|
0 months
|
|
Back pain
Time Frame: 0 months
|
visual analogue scale ranging from 0 (= no pain) to 10 (= worst pain)
|
0 months
|
|
Range of motion lumbar spine
Time Frame: 0 months
|
Range of motion lumbar spine using the Schober test
|
0 months
|
|
Typical physical activity
Time Frame: 0 months
|
Typical physical activity will be assessed using the self-administered short version of the German version of the International Physical Activity Questionnaire (IPAQ)
|
0 months
|
|
Disability
Time Frame: 0 months
|
Disability will be assessed using the Oswestry Disability Index (ODI)
|
0 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Annegret Muendermann, PhD, University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-01714
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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