Low Back PainTRUSCNCT03494452
Trunk Muscle Strength, Strength Endurance and Activity in Persons With Low Back Pain
An observational study of Low Back Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The research questions are if persons with low back pain (LBP) have lower trunk muscle strength, lower trunk muscle strength endurance and lower trunk muscle activity than healthy controls and if functional limitations because of LBP are related to the level of muscle strength, strength endurance and activity. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2017to 31 May 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 20 persons with LBP 20 age and sex matched healthy control persons
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
The research questions are if persons with low back pain (LBP) have lower trunk muscle strength, lower trunk muscle strength endurance and lower trunk muscle activity than healthy controls and if functional limitations because of LBP are related to the level of muscle strength, strength endurance and activity. To investigate this investigators will carry out a clinical assessment including questionnaires and a biomechanical assessment comprising muscle strength tests, muscle strength endurance tests and electromyographic (EMG) analysis of selected trunk muscles.
Read the 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).
- Conditions
- Low Back Pain
- Being tested
- No intervention
- Keywords
- electromyography, strength, strength endurance
- 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.
No interventionOther
There is no intervention in this cross-sectional study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention | |
| Healthy - no intervention | Healthy persons who perform sitting occupational activities for at least 4 hours/day Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic trunk muscle flexion strength
Maximum moment of isokinetic movement performed on a Biodex
Measured: 0 months
Isokinetic trunk muscle extension strength
Maximum moment of isokinetic movement performed on a Biodex
Measured: 0 months
Secondary outcomes (6)
Trunk muscle activity
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
Measured: 0 months
Isometric trunk muscle strength endurance
Biering-Soerensen test completion time of the will be recorded when the upper part of the body descended below the horizontal line
Measured: 0 months
Back pain
visual analogue scale ranging from 0 (= no pain) to 10 (= worst pain)
Measured: 0 months
Range of motion lumbar spine
Range of motion lumbar spine using the Schober test
Measured: 0 months
Typical physical activity
Typical physical activity will be assessed using the self-administered short version of the German version of the International Physical Activity Questionnaire (IPAQ)
Measured: 0 months
Disability
Disability will be assessed using the Oswestry Disability Index (ODI)
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start10 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Muendermann, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494452
- Sponsor's protocol ID
- 2017-01714
- Other IDs
- 2017
- Acronym
- TRUSC
- Status last verified
- Sep 2019
- First submitted
- 27 Feb 2018
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Muscle Strength, Strength Endurance and Activity in Persons With Low Back Pain
- ClinicalTrials.gov ID
- NCT03494452
- Acronym / sponsor ID
- TRUSC / 2017-01714
- Conditions
- Low Back Pain
- Keywords
- electromyography, strength, strength endurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 11 Apr 2018 (actual)
- 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.
The research questions are if persons with low back pain (LBP) have lower trunk muscle strength, lower trunk muscle strength endurance and lower trunk muscle activity than healthy controls and if functional limitations because of LBP are related to the level of muscle strength, strength endurance and activity. To investigate this investigators will carry out a clinical assessment including questionnaires and a biomechanical assessment comprising muscle strength tests, muscle strength endurance tests and electromyographic (EMG) analysis of selected trunk muscles.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain - no intervention | – | Other: No interventionPatients who perform sitting occupational activities for at least 4 hours/day and have had low back pain for at least the previous 6 months |
| Healthy - no intervention | – | Other: No interventionHealthy persons who perform sitting occupational activities for at least 4 hours/day |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 persons with LBP 20 age and sex matched healthy control persons
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| No interventionThere is no intervention in this cross-sectional study | Other | Healthy - no intervention, Low back pain - no intervention |
Primary outcome
Isokinetic trunk muscle flexion strength
Time frame: 0 months
Maximum moment of isokinetic movement performed on a Biodex
Isokinetic trunk muscle extension strength
Time frame: 0 months
Maximum moment of isokinetic movement performed on a Biodex
6 secondary outcomes
Trunk muscle activity
Time frame: 0 months
Isometric trunk muscle strength endurance
Time frame: 0 months
Back pain
Time frame: 0 months
Range of motion lumbar spine
Time frame: 0 months
Typical physical activity
Time frame: 0 months
Disability
Time frame: 0 months
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 30 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Annegret Muendermann, PhD principal investigator
University Hospital, Basel, Switzerland
1 site 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, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 6 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Isokinetic trunk muscle flexion strength (time frame: 0 months). 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?
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 30 Sep 2019.