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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03494452
Other study ID # 2017-01714
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2017
Est. completion date May 31, 2019

Study information

Verified date September 2019
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland University Hospital Basel Basel Basel Stadt

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isokinetic trunk muscle flexion strength Maximum moment of isokinetic movement performed on a Biodex 0 months
Primary Isokinetic trunk muscle extension strength Maximum moment of isokinetic movement performed on a Biodex 0 months
Secondary 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 0 months
Secondary 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 0 months
Secondary Back pain visual analogue scale ranging from 0 (= no pain) to 10 (= worst pain) 0 months
Secondary Range of motion lumbar spine Range of motion lumbar spine using the Schober test 0 months
Secondary 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) 0 months
Secondary Disability Disability will be assessed using the Oswestry Disability Index (ODI) 0 months
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