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Non-malignant PainNCT05535335

Brief-Illness Perception Questionnaire (Brief-IPQ) Used in Patients With Chronic Non-malignant Pain

An observational study of Non-malignant Pain and Chronic Pain, run by Zealand University Hospital at 1 site in Denmark.

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

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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Non-malignant Pain, Chronic Pain
How many people
364 participants
Where
1 siteDenmark
Study dates
6 Jun 2020to 3 Apr 2022
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Zealand University Hospital

    Køge, Region Sjælland, 4600

Other trials in Denmark

About this study

Official title: Brief-Illness Perception Questionnaire (Brief-IPQ) Used as Prediction of Outcome in Patients With Chronic Non-malignant Pain After Treatment in a Multidisciplinary Pain Clinic

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.

Read the detailed description

Chronic pain conditions are frequent in the danish population. More than 1.2 million Danes over the age of 16 are living with chronic pain. Chronic pain affects the health-related quality of life and functioning and is associated with reduced work ability, lost earnings and disability. At the Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark, patients with chronic pain are received and treated based on the Bio-Psycho-Social Pain Model. The treatment of patients with complex chronic non-malignant pain can be complicated by psychological and / or social factors. The need for a screening of psychological factors in connection with the examination and planning of the pain management in the Interdisciplinary Pain Center is obvious as the patient's perception of illness and expectation of treatment have been shown to play a role in the treatment response. The Brief Illness Perception Questionnaire (Brief-IPQ) provides a quick assessment of the patient's disease perception and expectation of treatment and has proved useful in clinical practice. In this study, a Danish version of Brief-IPQ is used, which initially was taken from https://www.uib.no. Items as stated in research by L. van Oort et al (2011) have been adapted to the Danish version. A copy of the latest version can be obtained from Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark.

The study:

Participants:

Patients with chronic low back pain admitted to the Pain Centre after June 2021 at ZUHK.

  • Persons ≥18 years
  • Persons who suffers from chronic back pain and are admitted to the Pain Centre at Zealand University Hospital in Køge, Denmark
  • Persons who have completed the BIPQ both at first and at last visit in the Pain Centre

Numbers 100 patients with both pre and post admission IBPQ score

Timeframe The data will be analyzed when there is a full dataset on 100 patients admitted from June 2020

Location of the study The Pain Centre at Zealand University Hospital, Koege

The patients will answer the questionnaire including the following data online before visiting the pain Centre and after treatment. Thereby the investigators can estimate the result of treatment compared to the BIPQ score before entry to treatment statistically. and thereby generate estimates concerning the success of pain treatment measured by BIPQ.

  • The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire, to assess the confidence people with ongoing pain have in performing activities while in pain.
  • Pain during movement is measured by the Numeric Rating Scale (NRS) from 0 to 10
  • For measuring the patients fear of movement related pain (fear avoidance) the 17 items questionnaire Tampa Scale of Kinesiophobia (TSK) will be used. 0= No pain at all and 10= worse imaginable pain
  • Pain catastrophizing is measured by the Pain Catastrophizing Scale (PCS) and includes the following items rumination ("I can't stop thinking about how much it hurts"), magnification ("I worry that something serious may happen"), and helplessness ("There is nothing I can do to reduce the intensity of the pain"). The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52.
  • Placebo measured with BIPQ. The BIPQ investigates the following; cognitive meaning (consequences, time perspective, personally control, treatment control and identity), emotional meaning (concerns, emotions), understanding of the condition and finally the patient´s own evaluation of the three most important reasons for the condition 8.

A decrease in BIPQ score will be defined as the mean +/- 1SD as cut-off.

All data will be derived from the PainData database. An examination is made of whether the patient meets the inclusion or exclusion criteria

  • Data will be stored in an Excel file and the statistical analyses will performed using SPSS

Ethical aspects:

All information will be treated confidentially and all data will be anonymized by a secretary. The Investigator will keep an identification list of all patients who have been included. This list will include the patient's full name and CPR number. Collected data will be recorded in a Case Report Form. The results will be stored and analyzed using a computer and the anonymity of the patients will be preserved and local data law will be observed. Data will be stored in accordance with existing regulations. Data is stored in anonymized form and correlation and regression analysis will be performed after 6 months. The study is conducted in accordance with applicable clinical trial rules. Investigators are responsible for the handling and archiving of data in accordance with applicable rules in addition to the Act on the Processing of Personal Data and the Health Act. Data belong to the investigators. The project has been reported to the local ethic committee.

Keywords
Placebo, chronic pain
Medical subject headings
Chronic Pain

What is being measured

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

  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.

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

Timeline

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

  1. First posted10 Sep 2022
  2. Study start6 Jun 2020
  3. Primary completion3 Apr 2022
  4. Study completion3 Apr 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
364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05535335
Sponsor's protocol ID
REG-1303-2022
Status last verified
Mar 2022
First submitted
24 Mar 2022
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-malignant Pain and Chronic Pain, run by Zealand University Hospital at 1 site in Denmark.

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 2 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 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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?

Differences in illness perception (time frame: Change in Illness peception score Measured at admission and at discharge between the 12-6-2020 - 03-04-2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Sep 2022.

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