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Low Back PainNCT04419675

The Course of Low Back Pain

An observational study of Low Back Pain and Type of Leg Pain (Radicular, Non-radicular), run by Radboud University Medical Center at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
347 participants
Where
6 sitesNetherlands
Study dates
1 Jun 2020to 1 Jun 2022
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: People with low back pain contacting physical therapy for treatment of low back pain

Who may be able to join

  • Low back pain
  • Age 18 years or older

Who cannot join

  • Pregnancy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Fysius Amersfoort

    Amersfoort

  • Fysius Arnhem

    Arnhem

  • Fysius Eindhoven

    Eindhoven

  • Fysius Nijmegen

    Nijmegen

  • Fysius Rotterdam

    Rotterdam

  • Fysius Winterswijk

    Winterswijk

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Observational Cohort, usual care = physical therapy
Medical subject headings
Low Back Pain, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational Cohort, usual care = physical therapyOther

    usual care = physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Limitations

    Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)

    Measured: Measurement at baseline

  2. Functional Limitations

    Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)

    Measured: Measurement at 6 weeks

  3. Functional Limitations

    Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)

    Measured: Measurement at 12 weeks

  4. Functional Limitations

    Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)

    Measured: Measurement at 26 weeks

  5. Functional Limitations

    Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)

    Measured: Measurement at 52 weeks

  6. Recovery rate

    Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)

    Measured: 26 weeks after inclusion

  7. Recovery rate

    Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)

    Measured: 52 weeks after inclusion

  8. Pain with Numeric Pain Rating Scale

    Numeric Pain Rating Scale (0= no pain, 10= maximum pain)

    Measured: measurement at baseline

  9. Pain with Numeric Pain Rating Scale

    Numeric Pain Rating Scale (0= no pain, 10= maximum pain)

    Measured: measurement at 6 weeks

  10. Pain with Numeric Pain Rating Scale

    Numeric Pain Rating Scale (0= no pain, 10= maximum pain)

    Measured: measurement at 12 weeks

  11. Pain with Numeric Pain Rating Scale

    Numeric Pain Rating Scale (0= no pain, 10= maximum pain)

    Measured: measurement at 26 weeks

  12. Pain with Numeric Pain Rating Scale

    Numeric Pain Rating Scale (0= no pain, 10= maximum pain)

    Measured: measurement at 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start1 Jun 2020
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
347 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419675
Sponsor's protocol ID
109643
Status last verified
Oct 2021
First submitted
27 May 2020
Last updated
13 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Storage at central data storage of Radboud University Medical Center

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain and Type of Leg Pain (Radicular, Non-radicular), run by Radboud University Medical Center at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Limitations (time frame: Measurement at baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04419675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.

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The Course of Low Back Pain (NCT04419675) | AzTrials