The Course of Low Back Pain

March 9, 2023 updated by: Radboud University Medical Center

The Course of Low Back Pain: a Prospective Cohort Study

This study aims to research the possible associations of education level, sedentary lifestyle, and type of low back pain (radicular vs non-radicular) with the course of low back pain and recovery rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

347

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

  • Netherlands
      • Amersfoort, Netherlands
        • Fysius Amersfoort
      • Arnhem, Netherlands
        • Fysius Arnhem
      • Eindhoven, Netherlands
        • Fysius Eindhoven
      • Nijmegen, Netherlands
        • Fysius Nijmegen
      • Rotterdam, Netherlands
        • Fysius Rotterdam
      • Winterswijk, Netherlands
        • Fysius Winterswijk

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with low back pain contacting physical therapy for treatment of low back pain

Description

Inclusion Criteria:

  • Low back pain
  • Age 18 years or older

Exclusion Criteria:

  • Pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Limitations
Time Frame: Measurement at baseline
Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
Measurement at baseline
Functional Limitations
Time Frame: Measurement at 6 weeks
Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
Measurement at 6 weeks
Functional Limitations
Time Frame: Measurement at 12 weeks
Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
Measurement at 12 weeks
Functional Limitations
Time Frame: Measurement at 26 weeks
Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
Measurement at 26 weeks
Functional Limitations
Time Frame: Measurement at 52 weeks
Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
Measurement at 52 weeks
Recovery rate
Time Frame: 26 weeks after inclusion
Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)
26 weeks after inclusion
Recovery rate
Time Frame: 52 weeks after inclusion
Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)
52 weeks after inclusion
Pain with Numeric Pain Rating Scale
Time Frame: measurement at baseline
Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measurement at baseline
Pain with Numeric Pain Rating Scale
Time Frame: measurement at 6 weeks
Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measurement at 6 weeks
Pain with Numeric Pain Rating Scale
Time Frame: measurement at 12 weeks
Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measurement at 12 weeks
Pain with Numeric Pain Rating Scale
Time Frame: measurement at 26 weeks
Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measurement at 26 weeks
Pain with Numeric Pain Rating Scale
Time Frame: measurement at 52 weeks
Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measurement at 52 weeks

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

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 (Actual)

June 1, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 3, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Storage at central data storage of Radboud University Medical Center

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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