The Course of Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Course of Low Back Pain: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419675
• Other study ID #: 109643
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2021
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Low back pain

• Age 18 years or older

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Observational Cohort, usual care = physical therapy
usual care = physical therapy

Locations

Country	Name	City	State
Netherlands	Fysius Amersfoort	Amersfoort
Netherlands	Fysius Arnhem	Arnhem
Netherlands	Fysius Eindhoven	Eindhoven
Netherlands	Fysius Nijmegen	Nijmegen
Netherlands	Fysius Rotterdam	Rotterdam
Netherlands	Fysius Winterswijk	Winterswijk

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Limitations	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
Primary	Functional Limitations	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
Primary	Functional Limitations	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
Primary	Functional Limitations	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
Primary	Functional Limitations	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
Primary	Recovery rate	Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)	26 weeks after inclusion
Primary	Recovery rate	Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)	52 weeks after inclusion
Primary	Pain with Numeric Pain Rating Scale	Numeric Pain Rating Scale (0= no pain, 10= maximum pain)	measurement at baseline
Primary	Pain with Numeric Pain Rating Scale	Numeric Pain Rating Scale (0= no pain, 10= maximum pain)	measurement at 6 weeks
Primary	Pain with Numeric Pain Rating Scale	Numeric Pain Rating Scale (0= no pain, 10= maximum pain)	measurement at 12 weeks
Primary	Pain with Numeric Pain Rating Scale	Numeric Pain Rating Scale (0= no pain, 10= maximum pain)	measurement at 26 weeks
Primary	Pain with Numeric Pain Rating Scale	Numeric Pain Rating Scale (0= no pain, 10= maximum pain)	measurement at 52 weeks