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Trunk Muscle Strength, Strength Endurance and Activity in Persons With Low Back Pain (TRUSC)

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ClinicalTrials.gov Identifier: NCT03494452
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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. 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.

Condition or disease Intervention/treatment
Low Back Pain Other: No intervention

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).

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Trunk Muscle Strength, Strength Endurance and Activity in Persons With Low Back Pain
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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
Other: No intervention
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
Other: No intervention
There is no intervention in this cross-sectional study




Primary Outcome Measures :
  1. Isokinetic trunk muscle flexion strength [ Time Frame: 0 months ]
    Maximum moment of isokinetic movement performed on a Biodex

  2. Isokinetic trunk muscle extension strength [ Time Frame: 0 months ]
    Maximum moment of isokinetic movement performed on a Biodex


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Back pain [ Time Frame: 0 months ]
    visual analogue scale ranging from 0 (= no pain) to 10 (= worst pain)

  4. Range of motion lumbar spine [ Time Frame: 0 months ]
    Range of motion lumbar spine using the Schober test

  5. 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)

  6. Disability [ Time Frame: 0 months ]
    Disability will be assessed using the Oswestry Disability Index (ODI)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
20 persons with LBP 20 age and sex matched healthy control persons
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494452


Locations
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Switzerland
University Hospital Basel
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Annegret Muendermann, PhD University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03494452    
Other Study ID Numbers: 2017-01714
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
electromyography, strength, strength endurance
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations