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Completed

NCT Number: NCT04419675

The Course of Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Behavior Lifestyle (Sedentary Behavior and Physical Activity) Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms Start Back Screening Tool Type of Leg Pain (Radicular, Non-radicular)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fysius Amersfoort, Amersfoort, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Low back pain
  • Age 18 years or older

Exclusion criteria

  • Pregnancy

Treatment and study plan

Observational Cohort, usual care = physical therapy

Other

usual care = physical therapy

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Recovery rate

    Time frame: 26 weeks after inclusion

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

  7. Recovery rate

    Time frame: 52 weeks after inclusion

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

  8. Pain with Numeric Pain Rating Scale

    Time frame: measurement at baseline

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

  9. Pain with Numeric Pain Rating Scale

    Time frame: measurement at 6 weeks

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

  10. Pain with Numeric Pain Rating Scale

    Time frame: measurement at 12 weeks

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

  11. Pain with Numeric Pain Rating Scale

    Time frame: measurement at 26 weeks

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

  12. Pain with Numeric Pain Rating Scale

    Time frame: measurement at 52 weeks

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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Course of Low Back Pain: a Prospective Cohort Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2020
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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