NCT03494452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

February 27, 2018

Last Update Submit

September 27, 2019

Conditions

Keywords

electromyography, strength, strength endurance

Outcome Measures

Primary Outcomes (2)

  • Isokinetic trunk muscle flexion strength

    Maximum moment of isokinetic movement performed on a Biodex

    0 months

  • Isokinetic trunk muscle extension strength

    Maximum moment of isokinetic movement performed on a Biodex

    0 months

Secondary Outcomes (6)

  • Trunk muscle activity

    0 months

  • Isometric trunk muscle strength endurance

    0 months

  • Back pain

    0 months

  • Range of motion lumbar spine

    0 months

  • Typical physical activity

    0 months

  • +1 more secondary outcomes

Study Arms (2)

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

Healthy - no intervention

Healthy persons who perform sitting occupational activities for at least 4 hours/day

Other: No intervention

Interventions

There is no intervention in this cross-sectional study

Healthy - no interventionLow back pain - no intervention

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20 persons with LBP 20 age and sex matched healthy control persons

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Annegret Muendermann, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

April 11, 2018

Study Start

October 10, 2017

Primary Completion

December 31, 2018

Study Completion

May 31, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations