NCT04419675

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 13, 2023

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

May 27, 2020

Last Update Submit

March 9, 2023

Conditions

Low Back PainType of Leg Pain (Radicular, Non-radicular)Lifestyle (Sedentary Behavior and Physical Activity)Start Back Screening Tool

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Recovery rate

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

    26 weeks after inclusion

  • Recovery rate

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

    52 weeks after inclusion

  • Pain with Numeric Pain Rating Scale

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

    measurement at baseline

  • Pain with Numeric Pain Rating Scale

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

    measurement at 6 weeks

  • Pain with Numeric Pain Rating Scale

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

    measurement at 12 weeks

  • Pain with Numeric Pain Rating Scale

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

    measurement at 26 weeks

  • Pain with Numeric Pain Rating Scale

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

    measurement at 52 weeks

Interventions

Observational Cohort, usual care = physical therapyOTHER

usual care = physical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Low back pain
  • Age 18 years or older

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Fysius Amersfoort

Amersfoort, Netherlands

Location

Fysius Arnhem

Arnhem, Netherlands

Location

Fysius Eindhoven

Eindhoven, Netherlands

Location

Fysius Nijmegen

Nijmegen, Netherlands

Location

Fysius Rotterdam

Rotterdam, Netherlands

Location

Fysius Winterswijk

Winterswijk, Netherlands

Location

MeSH Terms

Conditions

Low Back PainSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 5, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

March 13, 2023

Record last verified: 2021-10

Locations

NL(6)