NCT05535335

Brief Summary

The investigators wish to investigate if there are any difference in the BIPQ score in persons with chronic low back pain from admission to the Pain Centre at Zealand University Hospital Koege (ZUH), and when discharged.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 6, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
Last Updated

September 10, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

March 24, 2022

Last Update Submit

September 6, 2022

Conditions

Non-malignant PainChronic Pain

Keywords

Placebo, chronic pain

Outcome Measures

Primary Outcomes (1)

  • Differences in illness perception

    Change in Brief Illness perception will be measured by using the Brief Illness perception questionnaire. The IPQ-B consists of nine items rated on a scale from 0 (minimum) to 10 (maximum). Illness perception Scores 0-24, low scores, 24-56 moderate, 56- 80 high scores.

    Change in Illness peception score Measured at admission and at discharge between the 12-6-2020 - 03-04-2022

Other Outcomes (5)

  • Differences in Fear Avoidance

    Change in Fear avoidance will be measured at admission and at discharge between the 12-6-2020 - 03-04-2022

  • Differences in Quality of life

    Change in Quality of life will be measured at admission and at discharge between the 12-6-2020 - 03-04-2022

  • Differences in Pain Self efficacy

    Change in Pain Selv Efficacy will be measured at admission and at discharge between the 12-6-2020 - 03-04-2022

  • +2 more other outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with chronic non-malignant pain conditions reffered to the multidisciplinary pain clinic with low back pain

You may qualify if:

  • Patients admitted to the multidisciplinary pain clinic at Zealand University Hospital with low back pain
  • Understand Danish spoken and written

You may not qualify if:

  • Patients with insufficient cognitive abilities
  • Patients who decline to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anja Geisler, phd.

    Koge Universitets Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

September 10, 2022

Study Start

June 6, 2020

Primary Completion

April 3, 2022

Study Completion

April 3, 2022

Last Updated

September 10, 2022

Record last verified: 2022-03

Locations

DK(1)