Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients

December 3, 2018 updated by: Christoph Maier, Prof. Dr., Ruhr University of Bochum
Main of the study is to assess the reliability of a new objective tool to measure lumbar spine motion. The data will be collected from healthy subjects and subjects with frequent or daily low back pain in the last three months. In addition we compare the results of the motion measurements with disability and pain questionnaires such as the Roland Morris, Oswestry Disability Index and the Brief Pain Inventory.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Northrine-Westfalia
      • Bochum, Northrine-Westfalia, Germany, 44789
        • Berufsgenossenschaftliches Universitätklinikum Bergmannsheil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Low back pain patients were recruited among in-and outpatients of the Department of Pain Medicine at the Bergmannsheil, Bochum. The subjects of the control groups were recruited by distributing flyers in sport groups and among hospital staff and friends.

Description

Inclusion Criteria:

  • older than 18 years, informed consent, sufficient German skills <30 days low back pain in the last 90 days (control group) >31days of low back pain in the last 90 days (low back pain group)

Exclusion Criteria:

  • neurological disorder (including multiple sclerosis, Stroke, Parkinson´s disease), Current pain >= 4 (NSR)/intake of analgesic in the last 24h/ previous low back surgery (control group), inability to perform choreography (LBP group)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group 1
Never low back pain in the last 3 months
Control group 2
occasionally (1-30days) low back pain in the last 3 months
Low back pain group 3
frequently (31-60days) low back pain in the last 3 months
Low back pain group 4
daily (61-90days) low back pain in the last 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reliability of measurement tool
Time Frame: February 2012-February 2013
reliability of measurement tool
February 2012-February 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4385-12

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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